Nimenrix

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Neisseria meningitidis Group A polysaccharide 5 µg (polysaccharide conjugated to approx 15 mcg of tetanus toxoid); Neisseria meningitidis Group C polysaccharide 5 µg (polysaccharide conjugated to approx 15 mcg of tetanus toxoid); Neisseria meningitidis Group W135 polysaccharide 5 µg (polysaccharide conjugated to approx 7.5 mcg of tetanus toxoid); Neisseria meningitidis Group Y polysaccharide 5 µg (polysaccharide conjugated to approx 6.5 mcg of tetanus toxoid)
Available from:
Pfizer New Zealand Limited
INN (International Name):
Neisseria meningitidis Group A polysaccharide 5 µg (polysaccharide conjugated to approx 15 mcg of tetanus toxoid)
Pharmaceutical form:
Powder for injection with diluent
Composition:
Active: Neisseria meningitidis Group A polysaccharide 5 µg (polysaccharide conjugated to approx 15 mcg of tetanus toxoid) Neisseria meningitidis Group C polysaccharide 5 µg (polysaccharide conjugated to approx 15 mcg of tetanus toxoid) Neisseria meningitidis Group W135 polysaccharide 5 µg (polysaccharide conjugated to approx 7.5 mcg of tetanus toxoid) Neisseria meningitidis Group Y polysaccharide 5 µg (polysaccharide conjugated to approx 6.5 mcg of tetanus toxoid) Excipient: Sucrose Tetanus toxoid Trometamol hydrochloride Sodium chloride Water for injection
Prescription type:
Prescription
Manufactured by:
GlaxoSmithKline Biologicals SA
Therapeutic indications:
Nimenrix is indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal diseases caused by Neisseria meningitidis groups A, C, W-135 and Y
Product summary:
Package - Contents - Shelf Life: Combination pack, vial + syringe, with or without separate needles - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C - Combination pack, Vial + syringe, with or without separate needles - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C - Syringe, glass, 1.25 mL - Diluent-syringe - 1 dose units -   - Vial, glass, type 1 glass, 3 mL - Vaccine - 1 dose units -   - Vial, glass, type 1 glass, 3 mL - Vaccine - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C
Authorization number:
TT50-9534
Authorization date:
2014-04-02

Read the complete document

NIMENRIX

NIMENRIX

®

Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine

Consumer Medicine Information

What is in this leaflet

Please

read

this

leaflet

carefully

before you or your child are given

NIMENRIX.

This leaflet answers some common

questions about NIMENRIX. It does

contain

available

information. It does not take the place

talking

your

doctor

pharmacist.

All vaccines and medicines have risks

benefits.

Your

doctor

weighed the expected benefits of you

your

child

having

NIMENRIX

against the possible risks.

If you have any questions about

NIMENRIX,

ask

your

doctor,

nurse or pharmacist.

Keep this leaflet. You may need to

read it again.

What

NIMENRIX

is

used for

NIMENRIX is a vaccine used to help

prevent

meningococcal

disease,

caused

four

types

Neisseria

meningitidis

bacteria (types A, C, W

and Y)

.

NIMENRIX works by causing your

body to produce its own protection (or

antibodies),

against

these

types

meningococcal bacteria. NIMENRIX

cannot cause meningococcal disease.

most

common

types

meningococcal disease are meningitis

(infection of a lining around the brain

spinal

cord)

septicaemia

(blood infection).

Neisseria

bacteria

can less commonly infect the joints,

lungs or other organs.

Meningococcal disease is spread by

small droplets from the nose, mouth

or throat. Meningococcal disease is

generally

serious

sometimes

causes

long-term

effects

(e.g.

deafness, memory problems, loss of

fingers or toes), or death.

As with all vaccines, NIMENRIX

may not protect all people who are

vaccinated.

Also, NIMENRIX does not help to

protect against meningococcal disease

caused by other types of Neisseria, or

meningitis caused by other bacteria or

viruses.

NIMENRIX can be used in infants

from 6 weeks of age, children and

adults.

NIMENRIX may also be prescribed

for other people or situations.

If you are not sure whether you or

your

child

should

be

given

this

vaccine, talk to your doctor.

Before

you

or

your

child

is

given

NIMENRIX

WHEN

NIMENRIX

SHOULD

NOT BE GIVEN:

You or your child has had an

allergic reaction to NIMENRIX,

or any ingredient contained in

this vaccine.

The ingredients are listed at the

end of this leaflet.

Symptoms of an allergic reaction

may include:

shortness of breath

wheezing

difficulty

breathing

swelling

face,

lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

If you or your child have been

given

NIMENRIX

before

and

became unwell, tell your doctor

or nurse before the vaccine is

given.

You or your child has a severe

infection

with

a

high

temperature.

A minor infection, such as a cold,

should not be a problem, but talk

your

doctor

nurse

before

having the vaccine.

The expiry date printed on the

NIMENRIX pack has passed.

The NIMENRIX packaging is

torn

or

shows

signs

of

tampering.

BEFORE

BEING

GIVEN

NIMENRIX,

TELL

YOUR

DOCTOR OR NURSE IF:

You or your child have had a

serious reaction to any vaccine,

including.

an allergic reaction

difficulty breathing

swelling of the throat

fainting or collapse

shock-like

state

being

unresponsive

fits or convulsions

high temperature (greater than

40°C)

NIMENRIX

severe

skin

reaction

injection site

crying or screaming lasting for

more than 3 hours, in a child.

You or your child have allergies

to:

any medicines

any other substances, such as

foods, preservatives or dyes.

You or your child fainted with a

previous vaccine.

Fainting can occur following, or even

before any needle injection.

You or your child have these

medical conditions:

platelets

bleeding

disorder,

since

bleeding

occur

after

injection

NIMENRIX.

you or your child have any

condition,

treatment

medicines

that

affect

immune

response

infections. You or your child

may still have NIMENRIX if

your

doctor

nurse

recommends it, but may not be

protected

much

other

people

.

You

are

pregnant,

plan

to

become

pregnant

or

are

breastfeeding.

Your doctor will discuss the possible

risks

benefits

having

NIMENRIX

during

pregnancy

breastfeeding.

You or your child have had a

vaccine in the last 4 weeks, or

have

recently

taken

any

medicines, including medicines

that don’t need a prescription.

Some vaccines may be affected by

other

vaccines

medicines.

Your

doctor, pharmacist or nurse will be

able to tell you what to do

.

NIMENRIX

can

be

given

at

the

same time as the following vaccines:

Infants

from

6

weeks

up

to

12

months of age:

Combined

diphtheria,

tetanus,

acellular pertussis (DTaP), hepatitis

B, inactivated poliovirus (IPV) and

Haemophilus influenzae type b (Hib)

vaccines and 10-valent pneumococcal

conjugate vaccine.

Children from 12 months of age and

adults:

Hepatitis A and hepatitis b vaccines;

DTaP

vaccines,

including

combination

DTaP

vaccines

with

hepatitis

Hib;

measles-

mumps-rubella

(MMR)

vaccine,

including

combination

with

varicella (MMRV); seasonal flu and

valent

pneumococcal

conjugate

vaccines;

human

papillomavirus

bivalent

vaccine

(HPV2)

diphtheria

toxoid

acellular pertussis vaccine (Tdap) in

individuals aged 9 to 25 years.

If you have not told your doctor or

nurse about any of the above, tell

him or her before you or your child

is given NIMENRIX.

How

NIMENRIX

is

given

HOW IT IS GIVEN

Your

doctor

nurse

will

give

NIMENRIX

injection.

vaccine

injected

into

muscle,

usually in the thigh for babies from 6

to 12 weeks of age.

In children from 12 months of age and

adults, NIMENRIX can be injected

into the thigh or arm muscle.

WHEN IT IS GIVEN

Infants

6

weeks

to

less

than

6

months of age:

Your baby will receive two doses,

with the first dose given from 6 weeks

of age, and a 2 month interval before

the second dose. A third (booster)

dose is recommended at 12 months of

age.

Infants 6 months to less than 12

months of age:

Your baby will receive one dose

given from 6 months of age. A

booster dose is recommended at 12

months of age, with an interval of at

least 2 months after the initial dose.

Children from 12 months of age

and adults:

Most

people

will

given

NIMENRIX injection.

Some

people

increased

continued

risk

meningococcal

infection

given

initial

NIMENRIX injections; NIMENRIX

after another meningococcal vaccine;

and/or a booster dose of NIMENRIX.

Your doctor will advise if you or your

child need more than one NIMENRIX

injection.

IF

YOU

OR

YOUR

CHILD

MISS A DOSE

If a dose of NIMENRIX is missed,

talk

your

doctor

nurse

arrange

another

visit

soon

possible.

If you have any questions about

how this vaccine is to be given, talk

to

your

doctor,

nurse

or

pharmacist.

IF

YOU

TAKE

TOO

MUCH

(OVERDOSE)

For information on the management

overdose,

contact

National

Poisons

Centre

0800

(0800 POISON) (New Zealand).

When

you

or

your

child

are

given

NIMENRIX

THINGS YOU MUST DO

Keep a record of you or your child’s

vaccinations, and update this after

each injection.

Keep any follow-up visits with your

doctor or clinic.

If required, it is important for you or

your child to be given follow-up doses

NIMENRIX

make

sure

vaccine

best

chance

providing

protection

against

meningococcal disease

NIMENRIX

THINGS TO BE CAREFUL OF

Be

careful

driving

or

operating

machinery

until

you

know

how

NIMENRIX affects you.

In some people, vaccination can cause

dizziness or light headedness.

Side effects

Tell

your

doctor,

nurse

or

pharmacist as soon as possible if

you or your child does not feel well

after receiving NIMENRIX.

NIMENRIX, like all medicines and

vaccines, may cause unwanted side

effects in some people. Most of the

time

side

effects

serious;

however, sometimes they may need

medical treatment.

Do not be alarmed by the following

lists of side effects. You or your child

may not experience any of them.

Ask

your

doctor,

nurse

or

pharmacist to answer any questions

you may have.

Most

unwanted

side

effects

with

NIMENRIX are mild and clear up

within a few days. These effects, as

with other vaccines, generally occur

around the injection site.

Tell your doctor or nurse if you

notice

any

of

the

following

side

effects:

Very common (may occur in more

than 1 in 10 people)

pain, redness or swelling around

the injection site

loss of appetite

fever

drowsiness or feeling tired

headache

irritability/fussiness in a child

Common (may occur in up to 1 in

10 people)

diarrhoea, vomiting or nausea

bruising at the injection site

rash (in infants)

Uncommon (may occur in up to 1 in

100 people)

warmth,

itchiness,

lack

sensation, or a hard lump around

the injection site

dizziness

trouble sleeping

decreased sensation or itchiness of

the skin; rash

pain in a muscle, arm or leg

feeling unwell

crying in a child

large swelling of the vaccinated

limb associated with redness

As

with

all

vaccines

given

by

injection, there is a very small risk

of a serious allergic reaction. This

usually happens within hours, but

may

occur

days

to

weeks

after

vaccination.

If any of the following happen, tell

your doctor or nurse immediately,

or

go

to

the

Accident

and

Emergency

Department

at

your

nearest hospital:

swelling

limbs,

face,

eyes,

inside of nose, mouth or throat

shortness of breath, breathing or

swallowing difficulties

hives, itching (especially of the

hands or feet), reddening of skin

(especially

around

ears),

severe skin reactions

unusual tiredness or weakness that

is sudden and severe.

Tell

your

doctor,

nurse

or

pharmacist if you notice anything

else that is making you or your child

feel unwell.

Other side effects not listed above

may occur in some people.

There may also be some side effects

not yet known.

Storage

NIMENRIX is usually stored in the

doctor’s surgery or clinic, or at the

pharmacy.

However,

if

you

need

to

store

NIMENRIX:

keep

it

in

the

fridge,

stored

between 2ºC and 8ºC.

store it in the original pack, to

protect it from light.

keep it out of reach of children.

Do not freeze NIMENRIX, store it

in the bathroom, or leave it in the

car.

Ask your pharmacist what to do

with NIMENRIX that has expired

or not been used.

Product description

WHAT IT LOOKS LIKE

NIMENRIX comes as a white powder

in a vial, together with a pre-filled

syringe

glass

container

clear

liquid

(solvent).

powder

dissolved in the solvent by the doctor

or nurse, just before injection.

Ingredients

NIMENRIX

contains

agents

that

stimulate

immune

response

Neisseria meningitidis types A, C, W

and Y.

The vaccine also contains sucrose and

trometamol.

The solvent contains sodium chloride

(salt) and water for injection.

NIMENRIX vaccine does not contain

lactose, gluten, tartrazine or any other

azo dyes.

Supplier

NIMENRIX

only

available

prescribed by a doctor.

Pharmaceutical companies are not in

the position to give people medical

advice. Your doctor or pharmacist is

the best person to give you advice on

vaccination.

NIMENRIX

supplied

Zealand by:

NIMENRIX

Pfizer New Zealand Limited

PO Box 3998

Auckland, New Zealand

Toll Free number: 0800 736 363

This

leaflet

prepared

November 2019.

= Registered Trade Mark

NIMENRIX

is a registered

trademark of GlaxoSmithKline

Biologicals SA, licensed to Pfizer

Inc.

Read the complete document

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Page 1 of 30

NEW ZEALAND DATA SHEET

1. PRODUCT NAME

NIMENRIX

injection with diluent.

Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

After reconstitution, 1 dose (0.5 mL) contains:

Meningococcal polysaccharide - Group A

5 micrograms

Meningococcal polysaccharide - Group C

5 micrograms

Meningococcal polysaccharide - Group W-135

5 micrograms

Meningococcal polysaccharide - Group Y

5 micrograms

conjugated to tetanus toxoid carrier protein 44 micrograms

For the full list of excipients (see Section 6.1 List of excipients).

3. PHARMACEUTICAL FORM

Powder and solvent for solution for injection.

The powder or cake is white.

The solvent is clear and colourless.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

NIMENRIX is indicated for active immunisation of individuals from 6 weeks of age against

invasive meningococcal diseases caused by

Neisseria meningitidis

groups A, C, W-135 and

4.2 Dose and Method of Administration

Dosage

NIMENRIX should be used in accordance with available official recommendations.

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Age Group

Primary Immunisation

Booster

Infants from 6 weeks to less

than 6 months of age*

Two doses, each of 0.5 ml,

with the first dose given from

6 weeks of age, with an

interval of 2 months between

doses

At 12 months of age

Unvaccinated infants from

6 months to less than

12 months of age**

One dose of 0.5 ml given

from 6 months of age

At 12 months of age with

a minimum interval of at

least 2 months after the

primary dose

Children from 12 months of

age, adolescents and

adults**

One dose of 0.5 ml

Not routinely

administered

* See Section 5.1 Pharmacodynamic properties for further information.

**In some situations, consideration may be given to administering an additional primary dose or a booster

dose of NIMENRIX (see Section 4.4 Special warnings and precautions for use and Section 5.1

Pharmacodynamic properties for further information).

NIMENRIX may be given as a booster dose to individuals who have previously received

primary

vaccination

with

NIMENRIX

other

conjugated

plain

polysaccharide

meningococcal vaccines, see Sections 4.4 Special warnings and precautions for use and 5.1

Pharmacodynamic properties.

Special populations

Individuals who have underlying conditions predisposing them to meningococcal infection

due to anatomic or functional asplenia (such as sickle cell disease) may receive at least one

dose of NIMENRIX (see Sections 4.8 Undesirable effects and 5.1 Pharmacodynamic

properties).

Method of administration

NIMENRIX is for single use in one patient only.

NIMENRIX is for intramuscular injection only.

In infants, the recommended injection site the anterolateral aspect of the thigh. In

individuals from 1 year of age, the recommended injection site is the anterolateral aspect

of the thigh or deltoid muscle (see Sections 4.4 Special warnings and precautions for use

and 4.5 Interactions with other medicines and other forms of interaction).

For instructions on reconstitution of the vaccine before administration (see Section 6.6

Special precautions for disposal and other handling).

4.3 Contraindications

NIMENRIX should not be administered to subjects with hypersensitivity to the active

substances or to any of the excipients contained in the vaccine.

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4.4 Special Warnings and Precautions for Use

NIMENRIX should under no circumstances be administered intravascularly, intradermally

or subcutaneously.

It is good clinical practice to precede vaccination by a review of the medical history

(especially with regard to previous vaccination and possible occurrence of undesirable

effects) and a clinical examination.

As with all injectable vaccines, appropriate medical treatment and supervision should always

be readily available in case of a rare anaphylactic event following the administration of the

vaccine.

Intercurrent illness

As with other vaccines, NIMENRIX should be postponed in subjects suffering from an acute

severe febrile illness. The presence of a minor infection, such as a cold, should not result in

the deferral of vaccination.

Syncope

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic

response to the needle injection. It is important that procedures are in place to avoid injury

from faints.

Thrombocytopenia and coagulation disorders

As with other vaccines administered intramuscularly, NIMENRIX should be given with

caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may

occur following an intramuscular administration to these subjects.

Immunodeficiency

It may be expected that in patients receiving immunosuppressive treatment or patients with

immunodeficiency, an adequate immune response may not be elicited.

Persons with certain complement deficiencies and persons receiving treatment that inhibits

terminal complement activation (for example eculizumab) are at increased risk for invasive

disease caused by

Neisseria meningitidis

groups A, C, W-135 and Y even if they develop

antibodies following vaccination with NIMENRIX.

Special populations

Limited data are available on the safety and immunogenicity in individuals with increased

susceptibility to meningococcal infection due to anatomic or functional asplenia (such as

sickle cell disease). See Sections 4.2 Dose and method of administration, 4.8 Undesirable

effects, and 5.1 Pharmacodynamic properties.

Protection against meningococcal disease

NIMENRIX will only confer protection against

Neisseria meningitidis

groups A, C, W-135

and Y. The vaccine will not protect against other

Neisseria meningitidis

groups.

As with any vaccine, a protective immune response may not be elicited in all vaccine

recipients.

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Immune response in infants aged 6 months to less than 12 months

A single-dose administered at 6 months was associated with lower human complement serum

bactericidal assay (hSBA) titres to groups W-135 and Y compared with three doses

administered at 2, 4, and 6 months (see Section 5.1 Pharmacodynamic properties). The

clinical relevance of this finding is unknown. If an infant aged 6 months to less than 12

months is expected to be at immediate risk of invasive meningococcal disease due to

exposure to groups W-135 and Y, consideration may be given to administering a second

primary dose of NIMENRIX after an interval of 2 months.

Immune responses in toddlers aged 12-14 months

At 1 month post vaccination, toddlers aged 12-14 months had similar rabbit complement

serum bactericidal assay (rSBA) titres to groups A, C, W-135 and Y following one dose of

NIMENRIX or two doses of NIMENRIX given two months apart. At 1 year post vaccination,

the rSBA responses for groups A, C, W-135 and Y were similar in both the one and the two

dose groups (see Section 5.1 Pharmacodynamic properties).

Measured with hSBA, 1 month post vaccination, responses to groups W-135 and Y were

lower after a single dose than after 2 doses given two months apart, while responses to groups

A and C were similar in the two groups (see Section 5.1 Pharmacodynamic properties). At 1

year post vaccination, the hSBA responses for groups A, C, W-135 and Y were similar in

both the one and the two dose groups (see Section 5.1 Pharmacodynamic properties). The

clinical relevance of the findings is unknown. If a toddler is expected to be at particular risk

of invasive meningococcal disease due to exposure to groups W-135 and Y, consideration

may be given to administering a second dose after an interval of 2 months. Regarding waning

of antibody against group A or group C after a first dose of NIMENRIX in children aged 12-

23 months, see below, under Persistence of serum bactericidal antibody titres.

Persistence of serum bactericidal antibody titres

Persistence of antibodies has been evaluated up to 10 years after vaccination. The persistence

studies with NIMENRIX have shown a waning of serum bactericidal antibody titres against

group A when using hSBA (see Section 5.1 Pharmacodynamic properties). The clinical

relevance of this observation is unknown. However, if an individual is expected to be at

particular risk of exposure to group A and received a dose of NIMENRIX more than

approximately 1 year previously, consideration may be given to administering a booster dose.

Similar to the monovalent Men C comparator, a decline in antibody titres over time has been

observed. The clinical significance of this observation is unknown. A booster dose might be

considered in individuals remaining at high risk of exposure to meningococcal disease caused

by groups A, C, W-135 and Y (see Section 5.1, Pharmacodynamic properties).

Although NIMENRIX contains tetanus toxoid, this vaccine does not substitute for tetanus

immunisation.

Paediatric population

See Sections 4.1 Therapeutic indications; 4.2 Dose and method of administration; 4.4 Special

warnings and precautions for use (see under Protection against meningococcal disease); 4.5

Interactions with other medicines and other forms of interactions; 4.8 Adverse effects and

5.1 Pharmacodynamic properties.

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Elderly population

There are no data available.

4.5 Interactions with Other Medicines and Other Forms of Interaction

In infants, NIMENRIX can be given concomitantly with combined diphtheria, tetanus,

acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b

vaccines (DTaP/IPV/Hib/HepB), as well as 10-valent pneumococcal conjugate vaccine.

From age 1 year and above, NIMENRIX can be given concomitantly with any of the

following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles-mumps-

rubella (MMR) vaccine, measles-mumps-rubella-varicella (MMRV) vaccine, 10-valent

pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.

NIMENRIX can also be given concomitantly with combined diphtheria-tetanus-acellular

pertussis

(DTaP)

vaccines,

including

combination

DTaP

vaccines

with

hepatitis

inactivated

poliovirus

(IPV)

Haemophilus

influenzae

type

(Hib),

such

(DTaP/IPV/Hib/HepB) vaccine and 13-valent pneumococcal conjugate vaccine in the

second year of life.

In individuals aged 9 to 25 years, NIMENRIX can be given concomitantly with human

papillomavirus bivalent [Type 16 and 18] recombinant vaccine (HPV2).

Safety and immunogenicity of NIMENRIX was evaluated when sequentially administered

or co-administered with a DTaP/IPV/Hib/HepB vaccine in the second year of life. The

administration of NIMENRIX 1 month after the DTaP/IPV/Hib/HepB vaccine resulted in

lower MenA, MenC and MenW-135 GMTs as measured with rSBA. Clinical relevance of

this observation is unknown, since at least 99.4% of subjects (N=178) had rSBA titres ≥ 8

for each group (A, C, W-135, and Y). Whenever possible, NIMENRIX and a tetanus toxoid

(TT) containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, should be co-administered

or NIMENRIX should be administered at least 1 month before the TT-containing vaccine.

month

after

co-administration

with

combined

TT-containing

vaccine,

reduced

diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25

years, lower Geometric Mean antibody Concentrations (GMCs) were observed to each

pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin

[PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay

cut-off thresholds. The clinical relevance of these observations is unknown. There was no

impact of co-administration on immune responses to NIMENRIX or the tetanus or diphtheria

antigens included in Tdap.

One month after co-administration with a 10-valent pneumococcal conjugate vaccine in

toddlers aged 12 to 23 months, lower GMCs and opsonophagocytic assay (OPA) antibody

GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid

carrier protein). Clinical relevance of this observation is unknown. There was no impact of

co-administration on the other nine pneumococcal serotypes.

If NIMENRIX is to be given at the same time as another injectable vaccine, the vaccines

should always be administered at different injection sites.

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Page 6 of 30

As with other vaccines it may be expected that in patients receiving immunosuppressive

treatment an adequate response may not be elicited.

4.6 Fertility, Pregnancy and Lactation

Pregnancy

Pregnancy Category B2

There is limited experience with use of NIMENRIX in pregnant women.

Animal studies with NIMENRIX do not indicate direct or indirect harmful effects with

respect to pregnancy, embryo/foetal development, parturition or post-natal development (see

Section 5.3 Preclinical safety data).

NIMENRIX should be used during pregnancy only when clearly needed, and the possible

advantages outweigh the potential risks for the foetus.

Breast-feeding

The safety of NIMENRIX when administered to breastfeeding women has not been

evaluated. It is unknown whether NIMENRIX is excreted in human breast milk.

NIMENRIX should only be used during breast-feeding when the possible advantages

outweigh the potential risks.

Fertility

Animal studies with NIMENRIX do not indicate direct or indirect harmful effects with

respect to fertility (see Section 5.3 Preclinical safety data).

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects of NIMENRIX on the ability to drive and use machines have been

performed.

4.8 Undesirable Effects

Clinical Trial Data

The safety of NIMENRIX presented in the Table 1 below is based on two clinical study

datasets as follows:

A pooled analysis of data from 9,621 subjects administered a single dose of

NIMENRIX. This total included 3,079 toddlers (12 months to 23 months), 909

children between 2 and 5 years of age, 990 children between 6 and 10 years of age,

2,317 adolescents (11 to 17 years) and 2,326 adults (18 to 55 years). In a separate

study a single dose of NIMENRIX was administered to 274 individuals aged 56 years

and older.

Data from a study in infants aged 6 to 12 weeks at the time of the first dose (Study

MenACWY-TT-083), 1,052 subjects received at least one dose of

a primary series of

2 or 3 doses of NIMENRIX and 1,008 received a booster dose at approximately 12

months of age.

In an additional clinical study of age matched subjects who were either healthy or at increased

risk of meningococcal disease due to anatomical or functional asplenia (such as sickle cell

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Page 7 of 30

disease), the safety profile of NIMENRIX in at-risk children and adolescents was generally

similar to that observed in the non-asplenic population (see Section 5.1 Pharmacodynamic

properties).

Tabulated list of Adverse reactions

Adverse reactions reported are listed according to the following frequency:

Very common

≥ 1/10

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Very rare

< 1/10,000

Not known (cannot be estimated from the available data)

Table 1: Tabulated summary of adverse reactions by system organ class

System Organ Class

Frequency

Adverse reactions

Metabolism

nutrition

disorders

Very common

Appetite lost

Psychiatric disorders

Very common

Irritability

Uncommon

Insomnia

Crying

Nervous system disorders

Very common

Drowsiness

Headache

Uncommon

Hypoaesthesia

Dizziness

Gastrointestinal disorders

Common

Diarrhoea

Vomiting

Nausea*

Skin and subcutaneous tissue

disorders

Uncommon

Pruritus

Rash**

Musculoskeletal

connective tissue disorders

Uncommon

Myalgia

Pain in extremity

General

disorders

administration site conditions

Very common

Fever

Swelling

Pain at injection site

Redness at injection site

Fatigue

Common

Injection site haematoma*

Uncommon

Malaise

Injection site induration

Injection site pruritus

Injection site warmth

Injection site anaesthesia

Not known***

Extensive limb swelling at the

injection site, frequently

associated with erythema,

sometimes involving the

adjacent joint or swelling of

the entire injected limb

*Nausea and injection site haematoma occurred at a frequency of Uncommon in infants

**Rash occurred at a frequency of Common in infants

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Page 8 of 30

The adverse reactions headache, hypoaesthesia, dizziness, pruritus, myalgia, pain in extremity and fatigue were

not reported in the infant clinical study.

***ADR identified post-marketing

Local and general adverse reactions

In all age groups, the local adverse reactions of pain, redness and swelling at the injection

site were reported at a very common frequency after vaccination.

In the infant and toddler groups, the general adverse reactions of drowsiness, fever,

irritability/fussiness and loss of appetite were reported at a very common frequency after

vaccination.

In a separate infant study, 554 infants were primed with one or three doses of NIMENRIX

and 508 received booster doses in the second year of life. Local and general adverse reactions

in this study were similar in frequency to the larger infant study.

In the 12-14 months age group who received two doses of NIMENRIX given 2 months apart,

the first and second doses were associated with similar local and systemic reactogenicity.

The 2–5 year group reported general adverse reactions at a frequency ranging from common

(irritability, loss of appetite and fever) to very common (drowsiness).

In the 6-10, 11-17 and ≥ 18 years age groups, the general adverse reactions were reported at

a frequency ranging from common (gastrointestinal symptoms and fever) to very common

(headache and fatigue).

The local and general adverse reaction profile of a booster dose of NIMENRIX given to

subjects from 12 months of age after primary vaccination with NIMENRIX or other

conjugated or plain polysaccharide meningococcal vaccines, was similar to the local and

general adverse reaction profile observed after primary vaccination with NIMENRIX, except

gastrointestinal symptoms (including diarrhoea, vomiting, and nausea) which ranged from

common to very common among subjects 6 years of age and older (versus common after

primary vaccination).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows

continued

monitoring

benefit/risk

balance

medicine.

Healthcare

professionals

asked

report

suspected

adverse

reactions

http://nzphvc.otago.ac.nz/reporting/.

4.9 Overdose

No cases of overdose have been reported.

For advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764766).

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: bacterial vaccines, ATC code J07AH08.

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Mechanism of Action

Anti-capsular

meningococcal

antibodies

protect

against

meningococcal

disease

complement

mediated

bactericidal

activity.

NIMENRIX

induces

production

bactericidal antibodies against capsular polysaccharides of

Neisseria meningitidis

groups A,

C, W-135 and Y when measured by serum bactericidal antibody assays (SBA) using either

rSBA or hSBA.

By conjugating capsular polysaccharide to a protein carrier that contains T-cell epitopes,

meningococcal conjugate vaccines like NIMENRIX change the nature of the immune

response to capsular polysaccharide from T-cell independent to T-cell dependent.

CLINICAL TRIALS

Immunogenicity in infants

In Study MenACWY-TT-083, the immunogenicity of a 2-dose primary vaccination schedule

administered at 2 and 4 months of age was evaluated. Routinely used infant vaccines

DTaP/IPV/Hib/HepB and a 10-valent pneumococcal vaccine were co-administered. For

group C, rSBA and hSBA titres elicited by NIMENRIX were compared to a 2-dose priming

with licensed monovalent meningococcal conjugate group C vaccines, MenC-CRM and

MenC-TT

vaccines.

NIMENRIX

elicited

rSBA

hSBA

titres

against

four

meningococcal groups. The response against group C was non-inferior to the one elicited by

the licensed MenC-CRM and MenC-TT vaccines in terms of the percentage of subjects with

rSBA titres ≥8 at 1 month after the second dose.

For subjects initially vaccinated in infancy with NIMENRIX at 2 and 4 months of age and

receiving a NIMENRIX booster dose at 12 months of age, the increase in rSBA and hSBA

titres 1 month post-booster dose ranged between 15 and 80-fold for all groups and more than

99.0% of all infants achieved post-booster titres above 8 for both assays. The observed

booster response for group C was similar to that observed in subjects primed and boosted

with a monovalent MenC conjugate vaccine (TT or CRM conjugated). Results are shown in

Table 2.

Table 2:

rSBA and hSBA titres following two doses of NIMENRIX (or MenC-CRM or MenC-

TT) given 2 months apart with the first dose administered to infants 6-12 weeks of age and

following a booster at 12 months of age (Study MenACWY-TT-083)

Meningococcal

group

Vaccine

group

Time

point

rSBA*

hSBA**

(95%

(95% CI)

(95% CI)

(95% CI)

A

NIMENRIX

Post

dose 2

97.4%

(95.4;

98.6)

(182; 227)

96.5%

(93.0; 98.6)

(131; 188)

Booster

dose

99.6%

(98.4;

99.9)

1561

(1412;

1725)

99.5%

(97.4;100)

1007

(836;1214)

C

NIMENRIX

Post

dose 2

98.7%

(97.2;

99.5)

(540; 693)

98.6%

(96.0; 99.7)

1308

(1052; 1627)

Booster

dose

99.8%

(98.8;

100)

1177

(1059;

1308)

99.5%

(97.5; 100)

4992

(4086; 6100)

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In Study MenACWY-TT-087, infants received either a single primary dose at 6 months

followed by a booster dose at 15-18 months or three primary doses at 2, 4, and 6 months

followed by a booster dose at 15-18 months. All subjects also received DTaP-IPV/Hib and

10-valent pneumococcal conjugate vaccines at all time points. A single primary dose

administered at 6 months of age elicited robust rSBA titres to the four meningococcal groups,

as measured by the percentage of subjects with rSBA titres ≥8, that were comparable to

responses after the last dose of a three-dose primary series. A booster dose produced robust

responses, comparable between the two dosing groups, against all four meningococcal

groups. Results are shown in Table 3.

Table 3: rSBA* and hSBA** titres following a single dose of NIMENRIX in infants at 6 months

of age and pre-and post- booster at 15-18 months of age (Study MenACWY-TT-087)

Meningo-

coccal

group

Time point

rSBA*

hSBA**

N

≥8

(95% CI)

GMT

(95% CI)

N

≥8

(95% CI)

GMT

(95% CI)

Post dose

98.8%

(95.6; 99.9)

1333

(1035; 1716)

98.3%

(90.9; 100)

(206; 355)

Pre booster

81.7%

(74.0; 87.9)

(84.4; 186)

66.2%

(54.0; 77.0)

20.8

(13.5; 32.2)

Post

booster

99.3%

(96.1; 100)

2762

(2310; 3301)

100%

(95.7; 100)

1416

(1140; 1758)

Post dose

99.4%

(96.6; 100)

(482; 726)

100%

(94.6;100)

(382; 717)

MenC-

CRM

vaccine

Post

dose 2

99.6%

(98.4;

99.9)

(850;

1079)

100%

(98.2; 100)

3188

(2646; 3841)

Booster

dose

98.4%

(96.8;

99.4)

1051

(920;

1201.1)

100%

(98.3; 100)

5438

(4412; 6702)

MenC-TT

vaccine

Post

dose 2

100%

(99.2;

100)

1188

(1080;

1307)

100%

(98.4; 100)

2626

(2219; 3109)

Booster

dose

100%

(99.2;

100)

1960.2

(1776;

2163)

100%

(98.3; 100)

5542

(4765; 6442)

W-135

NIMENRIX

Post

dose 2

99.1%

(97.8;

99.8)

1605

(1383;

1862)

100%

(98.3; 100)

(644; 882)

Booster

dose

99.8%

(98.8;

100)

2777

(2485;

3103.6)

100%

(98.3; 100)

5128

(4504; 5826)

Y

NIMENRIX

Post

dose 2

98.2%

(96.6;

99.2)

(419; 558)

97.7%

(94.6; 99.2)

(276; 390)

Booster

dose

99.4%

(99.1;

99.9)

881.3

(788; 986)

100%

(98.3; 100)

2954

(2498; 3493)

The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort.

*rSBA analysis performed at Public Health England (PHE) laboratories in UK

**hSBA analysis performed at GSK laboratories

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Pre booster

65.6%

(56.9; 73.7)

27.4

(20.6; 36.6)

96.2%

(89.2; 99.2)

(108.5; 209.5)

Post

booster

99.3%

(96.1; 100)

2525

(2102; 3033)

100%

(96.1; 100)

13360

(10953; 16296)

W-135

Post dose

93.9%

(89.0; 97.0)

1256

(917; 1720)

87.2%

(74.3; 95.2)

(78.4; 238)

Pre booster

77.9%

(69.8; 84.6)

63.3

(45.6; 87.9)

100%

(93.3; 100)

(328; 559)

Post

booster

100%

(97.4; 100)

3145

(2637; 3750)

100%

(93.9; 100)

9016

(7045; 11537)

Post dose

98.8%

(95.6; 99.9)

1470

(1187; 1821)

92.3%

(81.5; 97.9)

(118; 323)

Pre Booster

88.5%

(81.8; 93.4)

(76.4; 148)

98.4%

(91.2; 100)

(292; 518)

Post

booster

100%

(97.4; 100)

2749

(2301; 3283)

100%

(94.8; 100)

5978

(4747; 7528)

The analysis of immunogenicity was conducted on the ATP cohort.

*rSBA analysis performed at PHE laboratories in UK

** hSBA analysis performed at Neomed, Canada

blood sampling performed 1 month post vaccination

Measurement of hSBA titres was a secondary endpoint in Study MenACWY-TT-087.

Although similar responses to groups A and C were observed with both dosing schedules, a

single primary dose in infants at 6 months was associated with lower hSBA titres to groups

W-135 and Y as measured by the percentage of subjects with hSBA titres ≥8 [87.2% (95%

CI: 74.3, 95.2) and 92.3% (95% CI: 81.5, 97.9), respectively] compared with three primary

doses at 2, 4, and 6 months of age [100% (95% CI: 96.6, 100) and 100% (95% CI: 97.1, 100),

respectively] (see Section 4.4 Special warnings and precautions for use ). After a booster

dose, the hSBA titres to all four serogroups were comparable between the two dosing

schedules (Table 3).

Immunogenicity in toddlers aged 12-23 months

In clinical studies MenACWY-TT-039 and MenACWY-TT-040, the immune response to

vaccination with either one dose of NIMENRIX or a licensed meningococcal C-CRM197

conjugate (MenC-CRM) vaccine was evaluated.

NIMENRIX elicited SBA titres against the four meningococcal groups, with group C rSBA

titres that were comparable to those elicited by a licensed meningococcal C-CRM

conjugate (MenC-CRM) vaccine in terms of the percentage of subjects with rSBA titres ≥8.

In Study MenACWY-TT-039, hSBA was also measured as a secondary endpoint. Results

are shown in Table 4.

Table 4: Bactericidal antibody responses SBA*

titres following a single dose of NIMENRIX

(or MenC-CRM) in toddlers aged 12-23 months (Studies MenACWY-TT-039/040)

Menin

gococc

al

group

Vaccine

Group

Study MenACWY-TT-039

(1)

Study MenACWY-TT-040

(2)

rSBA*

hSBA*

rSBA*

N

≥8

(95%CI)

GMT

(95%CI)

N

≥8

(95%CI)

GMT

(95%CI)

N

≥8

(95%CI)

GMT

(95%CI)

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Page 12 of 30

NIMEN

99.7%

(98.4; 100)

2205

(2008; 2422)

77.2%

(72.4; 81.6)

19.0

(16.4;

22.1)

98.4%

(95.3;

99.7)

3170

(2577; 3899)

NIMEN

99.7%

(98.4; 100)

(437; 522)

98.5%

(96.6; 99.5)

(175; 219)

97.3%

(93.7;

99.1)

(672; 1021)

MenC-

97.5%

(92.9; 99.5)

(170; 265)

81.9%

(73.7; 88.4)

40.3

(29.5;

55.1)

98.2%

(93.8;

99.8)

(521; 918)

W-135

NIMEN

100%

(99.0; 100)

2682

(2453; 2932)

87.5%

(83.5 ; 90.8)

48.9

(41.2;

58.0)

98.4%

(95.4;

99.7)

4022

(3269; 4949)

NIMEN

100%

(99.0; 100)

2729

(2473; 3013)

79.3%

(74.5; 83.6)

30.9

(25.8;

37.1)

97.3%

(93.8;

99.1)

3168

(2522; 3979)

The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohorts.

blood sampling performed 42 to 56 days post vaccination

blood sampling performed 30 to 42 days post vaccination

* SBA analyses performed at GSK laboratories

N = number of subjects with available results

GMT = geometric mean antibody titre

Study

MenACWY-TT-104,

NIMENRIX

elicited

rSBA

titres

against

four

meningococcal groups following one or two doses administered 2 months apart that were

similar in terms of the percentage of subjects with rSBA titre ≥8 and GMT. Results are shown

in Table 5.

Table 5: rSBA and hSBA titres following one or two doses of NIMENRIX with the first dose

administered to in toddlers aged 12-14 months (Study MenACWY-TT-104

)

Menin

go-

coccal

group

Nimenri

x dose

group

Time

point

(1)

rSBA*

hSBA*

N

≥8

(95% CI)

GMT

(95% CI)

N

≥8

(95% CI)

GMT

(95% CI)

A

1 dose

1 Month

Post dose 1

97.8%

(94.4; 99.4)

1437

(1118; 1847)

95.9%

(88.6; 99.2)

(86.8; 161)

1 Year

Post dose 1

63.5%

(55.7; 70.8)

62.7

(42.6; 92.2)

35.7%

(24.6; 48.1)

(4.1; 8.9)

2 doses

1 Month

Post dose 1

96.8%

(92.8; 99.0)

1275

(970; 1675)

97.0%

(89.5; 99.6)

(98.1; 180)

1 Month

Post dose 2

98.0%

(94.3; 99.6)

1176

(922; 1501)

97.0%

(89.5; 99.6)

(126; 230)

1 Year

Post dose 2

70.6%

(62.4; 77.9)

76.6

(50.7; 116)

35.5%

(23.7; 48.7)

(4.2; 10.0)

C

1 dose

1 Month

Post dose 1

95.0%

(90.7; 97.7)

(346; 592)

98.7%

(93.1; 100)

(105; 220)

1 Year

Post dose 1

49.1%

(41.3; 56.9)

16.2

(12.4; 21.1)

80.3%

(69.1; 88.8)

35.2

(22.5; 55.2)

2 doses

1 Month

Post dose 1

95.5%

(91.0; 98.2)

3696

(281; 48)

95.7%

(88.0; 99.1)

(110; 236)

1 Month

Post dose 2

98.7%

(95.3; 99.8)

(522; 783)

100%

(94.8; 100)

1753

(1278; 2404)

1 Year

Post dose 2

55.2%

(46.7; 63.6)

21.2

(15.6; 28.9)

90.5%

(80.4; 96.4)

73.4

(47.5; 113.4)

W-135

1 dose

1 Month

Post dose 1

95.0%

(90.8; 97.7)

2120

(1601; 2808)

62.5%

(50.3; 73.6)

27.5

( 16.1; 46.8)

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Page 13 of 30

Menin

go-

coccal

group

Nimenri

x dose

group

Time

point

(1)

rSBA*

hSBA*

N

≥8

(95% CI)

GMT

(95% CI)

N

≥8

(95% CI)

GMT

(95% CI)

1 Year

Post dose 1

65.3%

(57.5; 72.5)

57.2

(39.9; 82.0)

95.8%

(88.3; 99.1)

(150; 291)

2 doses

1 Month

Post dose 1

94.9%

(90.3; 97.8)

2030

(1511; 2728)

68.9%

(55.7; 80.1)

26.2

(16.0; 43.0)

1 Month

Post dose 2

100%

(97.6; 100)

3533

(2914; 4283)

97.1%

(90.1; 99.7)

(550; 1041)

1 Year

Post dose 2

77.6%

(69.9; 84.2)

(82.7; 183)

98.5%

(91.7; 100.0)

(168; 321)

Y

1 dose

1 Month

Post dose 1

92.8%

(88.0; 96.1)

(705; 1285)

67.6%

(55.5; 78.20)

41.2

(23.7; 71.5)

1 Year

Post dose 1

73.1%

(65.7; 79.6)

76.8

(54.2; 109)

91.9%

(82.2; 97.3)

(97.2; 215)

2 doses

1 Month

Post dose 1

93.6%

(88.6; 96.9)

933.3

(692; 1258)

64.3%

(50.4; 76.6)

31.9

(17.6; 57.9)

1 Month

Post dose 2

99.3%

(96.3; 100)

1134

(944; 1360)

95.3%

(86.9; 99.0)

(339; 775)

1 Year

Post dose 2

79.7%

(72.2; 86.0)

(77.5; 163)

87.9%

(76.7; 95.0)

(88.5; 234)

The analysis of immunogenicity was conducted on the ATP cohort

(1)

blood sampling performed 21-48 days post vaccination and 44-60 weeks post vaccination

rSBA analysis performed at PHE laboratories

**hSBA analysis performed at GSK laboratories

In Study MenACWY-TT-104, hSBA titres were measured as a secondary endpoint. In terms

of the percentage of subjects with hSBA titres ≥8, at 1 month post vaccination, hSBA titres

against groups W-135 and Y were higher after two doses of NIMENRIX than after one dose,

while the hSBA titres against groups A and C were similar in the two dose groups. At 1 year

post vaccination, the percentage of subjects with hSBA titres ≥8 for all four meningococcal

groups were similar in both the one and two dose groups (Table 5).

Immunogenicity in children aged 2-10 years

In two comparative studies of non-inferiority conducted in subjects aged 2-10 years, one dose

of NIMENRIX was compared to either the licensed ACWY-PS vaccine (Study MenACWY-

TT-038 ) or a licensed MenC-CRM vaccine (Study MenACWY-TT-081).

In Study MenACWY-TT-038, a single dose of NIMENRIX was demonstrated to be non-

inferior to the licensed ACWY-PS vaccine in terms of vaccine response to the four

meningococcal groups as shown in Table 6.

Table 6: rSBA* titres following a single dose of NIMENRIX or ACWY-PS vaccine in

children aged 2-10 years Study MenACWY-TT-038)

Mening

ococcal

group

NIMENRIX

(1)

ACWY-PS vaccine

(1)

N

VR

(95%CI)

GMT

(95%CI)

N

VR

(95%CI)

GMT

(95%CI)

89.1%

(86.3 91.5)

6343

(5998; 6708)

64.6%

(57.4; 71.3)

2283

(2023; 2577)

96.1%

(94.4; 97.4)

4813

(4342; 5335)

89.7%

(85.1; 93.3)

1317

(1043; 1663)

W-135

97.4%

(95.9; 98.4)

11543

(10873; 12255)

82.6%

(77.2; 87.2)

2158

(1815; 2565)

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92.7%

(90.5; 94.5)

10825

(10233; 11452)

68.8%

(62.5; 74.6)

2613

(2237; 3052)

The analysis of immunogenicity was conducted on the ATP cohort.

Blood sampling performed 1 month post vaccination

VR: vaccine response, defined as the proportion of subjects with:

rSBA titres ≥ 32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8)

at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (i.e.,

pre vaccination rSBA titre ≥8)

*rSBA analysis performed at GSK laboratories

N = number of subjects with available results

GMT = geometric mean antibody titre

In Study MenACWY-TT-081, a single dose of NIMENRIX (N=268) was demonstrated to

be non-inferior to a licensed MenC-CRM vaccine (N=92) in 2 to 10 year olds in terms of

group C vaccine response one month post-vaccination [94.8% (95% CI: 91.4; 97.1) and

95.7% (95% CI: 89.2; 98.8) respectively]. Group C geometric mean titres (GMTs) were

lower for the NIMENRIX group [2795 (95% CI: 2393; 3263)] versus the MenC-CRM group

[5292 (95% CI: 3815; 7340)].

Immunogenicity in adolescents aged 11-17 years and adults aged over 18 years

In two clinical studies, one dose of NIMENRIX was compared to one dose of ACWY-PS

vaccine administered to adolescents aged 11-17 years (study MenACWY-TT-036) and in

adults aged 18-55 years (study MenACWY-TT-035).

In both adolescents and adults, NIMENRIX was demonstrated to be immunologically non-

inferior to the ACWY-PS vaccine in terms of vaccine response. The rSBA titres to the four

meningococcal groups elicited by NIMENRIX were either similar to or higher than those

elicited by the ACWY-PS vaccine as shown in Table 7.

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Table 7: rSBA* titres following a single dose of NIMENRIX or ACWY-PS in adolescents

aged 11-17 years and adults aged ≥ 18-55 years (Studies MenACWY-TT-035/036)

Meningo-

coccal

group

Vaccine

group

Study MenACWY-TT-036

(11-17 years)

(1)

Study MenACWY-TT-035

(18-55 years)

(1)

N

VR

(95% CI)

GMT

(95% CI)

N

VR

(95% CI)

GMT

(95% CI)

A

NIMENRI

X

85.4%

(82.1; 88.2)

5928

(5557; 6324)

80.1%

(77.0; 82.9)

3625

(3372; 3897)

ACWY-

PS

vaccine

77.5%

(70.9; 83.2)

2947

(2612; 3326)

69.8%

(63.8; 75.4)

2127

(1909; 2370)

C

NIMENRI

X

97.4%

(95.8; 98.5)

13110

(11939; 14395)

91.5%

(89.4; 93.3)

8866

(8011; 9812)

ACWY-

PS

vaccine

96.7%

(93.3; 98.7)

8222

(6807; 9930)

92.0%

(88.3; 94.9)

7371

(6297; 8628)

W-135

NIMENRI

X

96.4%

(94.6; 97.7)

8247

(7639; 8903)

90.2%

(88.1; 92.1)

5136

(4699; 5614)

ACWY-

PS

vaccine

87.5%

(82.3; 91.6)

2633

(2299; 3014)

85.5%

(80.9; 89.4)

2461

(2081; 2911)

Y

NIMENRI

X

93.8%

(91.6; 95.5)

14086

(13168; 15069)

87.0%

(84.6; 89.2)

7711

(7100; 8374)

ACWY-

PS

vaccine

78.5%

(72.5; 83.8)

5066

(4463; 5751)

78.8%

(73.6; 83.4)

4314

(3782; 4921)

The analysis of immunogenicity was conducted on the ATP cohorts.

Blood sampling performed 1 month post vaccination

VR: vaccine response, defined as

the proportion of subjects with:

rSBA titres ≥ 32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8)

or at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (i.e.,

pre vaccination rSBA titre ≥8)

* rSBA analysis performed at GSK laboratories

N = number of subjects with available results

GMT = geometric mean antibody titre

Persistence of immune response

Persistence of immune response in toddlers aged 12-23 months at vaccination

In children vaccinated at toddler age, the persistence of rSBA and hSBA titres was evaluated

up to 4 years in Study MenACWY-TT-048 . Results are shown in Table 8.

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Table 8: rSBA and hSBA titres up to 4 years following NIMENRIX (or MenC-CRM) in

toddlers aged 12-23 months (Study MenACWY-TT-048)

Mening

ococcal

group

Vaccine

group

Time-

point

(Years)

rSBA*

hSBA**

N

≥8

(95%CI)

GMT

(95%CI)

N

≥8

(95%CI)

GMT

(95%CI)

A

NIMENRIX

59.9%

(53.7; 65.9)

19.3

(15.7; 23.6)

35.9%

(29.9; 42.1)

(4.8; 7.0)

74.1%

(67.9; 79.7)

(77.6; 148)

28.8%

(22.6; 35.6)

(4.0; 6.0)

C

NIMENRIX

35.9%

(30.1; 42.0)

(8.1; 11.7)

78.3%

(72.7; 83.2)

37.8

(29.4; 48.6)

40.4%

(34.0; 47.2)

12.3

(9.8; 15.3)

73.2%

(66.7; 79.1)

32.0

(23.8; 43.0)

MenC-CRM

vaccine

13.0%

(4.9; 26.3)

(4.2; 7.7)

41.9%

(24.5; 60.9)

(3.7; 10.3)

35.6%

(21.9; 51.2)

13.5

(7.4; 24.5)

46.9%

(29.1; 65.3)

11.3

(4.9; 25.6)

W-135

NIMENRIX

49.8%

(43.6; 56.0)

24.9

(19.2; 32.4)

82.3%

(77.0; 86.8)

52.0

(41.4; 65.2)

49.3%

(42.6; 56.1)

30.5

(22.4; 41.5)

80.6%

(73.7; 86.3)

47.1

(35.7; 62.2)

Y

NIMENRIX

53.8%

(47.6; 60.0)

22.3

(17.6; 28.4)

72.0%

(66.0; 77.5)

33.2

(25.9; 42.5)

58.2%

(51.5; 64.7)

36.2

(27.1; 48.4)

65.4%

(56.5; 73.5)

29.8

(20.2; 44.1)

The analysis of immunogenicity was conducted on the ATP cohort for persistence adapted for each time-point.

* rSBA analysis performed at Health Protection Agency (HPA) laboratories in UK

** hSBA analysis performed at GSK laboratories

N = number of subjects with available results

GMT = geometric mean antibody titre

rSBA and hSBA titres were determined over a period of 10 years in children initially

vaccinated with one dose of NIMENRIX or MenC-CRM at 12 to 23 months of age in Study

MenACWY-TT-027. Persistence of SBA titres was evaluated in two extension studies:

MenACWY-TT-032 (up to 5 years) and MenACWY-TT-100 (up to 10 years). Study

MenACWY-TT-100 also evaluated the response to a single booster dose of NIMENRIX

administered 10 years following the initial vaccination with NIMENRIX or MenC-CRM.

Results are shown in Table 9 (see section 4.4 Special warnings and precautions for use).

Table 9: rSBA and hSBA titres following a single dose of NIMENRIX (or MenC-CRM) in

toddlers aged 12-23 months, persistence up to 10 years, and post-booster administered 10

years following initial vaccination (Studies MenACWY-TT-027/032/100)

Mening

ococcal

group

Vaccine

group

Time-point

rSBA*

hSBA**

N

≥8

(95%CI)

GMT

(95%CI)

N

≥8

(95%CI)

GMT

(95%CI)

A

NIMEN

RIX

Month 1

100%

(98.4; 100)

3707

(3327; 4129)

91.2%

(86.7; 94.6)

59.0

(49.3; 70.6)

Year 4

64.4%

(48.8; 78.1)

35.1

(19.4; 63.4)

52.3%

(36.7; 67.5)

(5.4; 14.2)

Year 5

73.5%

(58.9; 85.1)

37.4

(22.1; 63.2)

35.6%

(21.9; 51.2)

(3.4; 7.8)

Year 10

(Pre-booster)

66.1%

(53.0; 77.7)

28.9

(16.4; 51.0)

25.4%

(15.0; 38.4)

(3.0; 5.9)

(Post-

booster)

(3,4)

98.4%

(91.3; 100)

5122

(3726; 7043)

100%

(94.2; 100)

1534

(1112; 2117)

C

NIMEN

RIX

Month 1

100%

(98.3; 100)

(779; 991)

99.1%

(96.8; 99.9)

(165; 219)

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Year 4

97.8%

(88.2; 99.9)

(62.7; 192)

97.8%

(88.2; 99.9)

(214; 640)

Year 5

77.6%

(63.4; 88.2)

48.9

(28.5; 84.0)

91.7%

(80.0; 97.7)

(124; 379)

Year 10

(Pre-booster)

82.3%

(70.5; 90.8)

(71.1; 231)

91.7%

(81.6; 97.2)

(197; 619)

(Post-

booster)

(3,4)

100%

(94.2; 100)

7164

(5478; 9368)

100%

(93.9; 100)

33960

(23890; 48274)

MenC-

CRM

vaccine

Month 1

98.5%

(92.1; 100)

(297; 580)

72.1%

(59.9; 82.3)

21.2

(13.9; 32.3)

Year 4

80.0%

(44.4; 97.5)

(22.6; 832)

70.0%

(34.8; 93.3)

91.9

(9.8; 859)

Year 5

63.6%

(30.8; 89.1)

26.5

(6.5; 107)

90.9%

(58.7; 99.8)

(21.2; 557)

Year 10

(Pre-booster)

87.5%

(61.7; 98.4)

86.7

(29.0; 259)

93.3%

(68.1; 99.8)

(40.0; 344)

(Post-

booster)

(3,4)

100%

(79.4; 100)

5793

(3631; 9242)

100%

(78.2; 100)

42559

(20106; 90086)

W-135

NIMEN

RIX

Month 1

100%

(98.4; 100)

5395

(4870; 5976)

79.7%

(73.0; 85.3)

38.8

(29.7; 50.6)

Year 4

60.0%

(44.3; 74.3)

50.8

(24.0; 108)

84.4%

(70.5; 93.5)

76.9

(44.0; 134)

Year 5

34.7%

(21.7; 49.6)

18.2

(9.3; 35.3)

82.6%

(68.6; 92.2)

59.7

(35.1; 101)

Year 10

(Pre-booster)

30.6%

(19.6; 43.7)

15.8

(9.1; 27.6)

44.2%

(30.5; 58.7)

(4.9; 12.2)

(Post-

booster)

(3,4)

100%

(94.2; 100)

25911

(19120;

35115)

100%

(94.2; 100)

11925

(8716; 16316)

Y

NIMEN

RIX

Month 1

100%

(98.4; 100)

2824

(2529; 3153)

66.7%

(59.7; 73.1)

24.4

(18.6; 32.1)

Year 4

62.2%

(46.5; 76.2)

44.9

(22.6; 89.3)

87.8%

(73.8; 95.9)

74.6

(44.5; 125)

Year 5

42.9%

(28.8; 57.8)

20.6

(10.9; 39.2)

80.0%

(65.4; 90.4)

70.6

(38.7; 129)

Year 10

(Pre-booster)

45.2%

(32.5; 58.3)

27.4

(14.7; 51.0)

42.9%

(29.7; 56.8)

(5.5; 15.1)

(Post-

booster)

(3,4)

98.4%

(91.3; 100)

7661

(5263; 11150)

100%

(94.1; 100)

12154

(9661; 15291)

The analysis of immunogenicity conducted on the ATP cohorts for 1 month and 5 years post vaccination and

the booster ATP cohort

(1) Study MenACWY-TT-027

(2) Study MenACWY-TT-032

(3) Study MenACWY-TT-100

(4) Blood sampling was performed 1 month after a booster dose at Year 10.

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE

laboratories in UK for subsequent sampling time points.

** hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in Study

MenACWY-TT 100.

Persistence of booster response

Study MenACWY-TT-102 evaluated the persistence of SBA titres up to 6 years after a

booster dose of NIMENRIX or MenC-CRM

administered in Study MenACWY-TT-048

to children who initially received the same vaccine at 12 to 23 months of age in Study

MenACWY-TT-039. A single booster dose was administered 4 years after the initial

vaccination. Results are shown in Table 10 (see Section 4.4 Special warnings and precautions

for use).

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Table 10:

rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in

toddlers aged 12-23 months, persistence at 4 years and response following a booster 4 years after

initial vaccination, and persistence up to 6 years following booster vaccination (Studies

MenACWY-TT-039/048/102)

Meningo

-coccal

group

Vaccine

group

Time point

rSBA*

hSBA**

N

≥8

(95% CI)

GMT

(95% CI)

N

≥8

(95% CI)

GMT

(95% CI)

A

NIMENRIX

Month 1

99.7%

(98.4; 100)

2205

(2008; 2422)

77.2%

(72.4; 81.6)

19.0

(16.4; 22.1)

Year 4

(Pre-Nimenrix

booster)

74.5%

(68.1; 80.2)

(80.3; 156)

28.9%

(22.5; 35.9)

(3.9; 5.9)

(Post-

booster)

(2,3)

100%

(98.3; 100)

7173

(6389; 8054)

99.5%

(97.3; 100)

1343

(1119; 1612)

5 years after

booster dose

89.8%

(83.4; 94.3)

(163; 322)

53.3%

(44.6; 62.0)

13.2

(9.6; 18.3)

6 years after

booster dose

92.5%

(86.7; 96.4)

(214; 413)

58.5%

(49.5; 67.0)

14.4

(10.5; 19.7)

C

NIMENRIX

Month 1

99.7%

(98.4; 100)

(437; 522)

98.5%

(96.6; 99.5)

(175; 219)

Year 4

(Pre-Nimenrix

booster)

39.9%

(33.3; 46.8)

12.1

(9.6; 15.2)

73.0%

(66.3; 79.0)

31.2

(23.0; 42.2)

(Post-

booster)

(2,3)

100%

(98.3; 100)

4512

(3936; 5172)

100%

(98.3; 100)

15831

(13626; 18394)

5 years after

booster dose

80.3%

(72.6; 86.6)

66.0

(48.1; 90.5)

99.3%

(96.0; 100)

(261; 435)

6 years after

booster dose

71.6%

(63.2; 79.1)

39.6

(28.6; 54.6)

97.7%

(93.4; 99.5)

(195; 345)

MenC-CRM

vaccine

Month 1

97.5%

(92.9; 99.5)

(170; 265)

81.9%

(73.7; 88.4)

40.3

(29.5; 55.1)

Year 4

(Pre-MenC-

booster)

37.2%

(23.0; 53.3)

14.3

(7.7; 26.5)

48.4%

(30.2; 66.9)

11.9

(5.1; 27.6)

(Post-

booster)

(2,3)

100%

(91.8; 100)

3718

(2596; 5326)

100%

(89.4; 100)

8646

(5887; 12699)

5 years after

booster dose

78.3%

(56.3; 92.5)

47.3

(19.0; 118)

100%

(85.2; 100)

(139; 420)

6 years after

booster dose

65.2%

(42.7; 83.6)

33.0

(14.7; 74.2)

95.7%

(78.1; 99.9)

(94.1; 305)

W-135

NIMENRIX

Month 1

100%

(99.0; 100)

2682

(2453; 2932)

87.5%

(83.5; 90.8)

48.9

(41.2; 58.0)

Year 4

(Pre-Nimenrix

booster)

48.8%

(41.9; 55.7)

30.2

(21.9; 41.5)

81.6%

(74.7; 87.3)

48.3

(36.5; 63.9)

(Post-

booster)

(2,3)

100%

(98.3; 100)

10950

(9531; 12579)

100%

(98.1; 100)

14411

(12972; 16010)

5 years after

booster dose

88.3%

(81.7; 93.2)

(130; 261)

100%

(97.3; 100)

(276; 388)

6 years after

booster dose

85.8%

(78.7; 91.2)

(118; 251)

98.5%

(94.7; 99.8)

(255; 388)

Y

NIMENRIX

Month 1

100%

(99.0; 100)

2729

(2473; 3013)

79.3%

(74.5; 83.6)

30.9

(25.8; 37.1)

Year 4

(Pre-Nimenrix

booster)

58.2%

(51.3; 64.9)

37.3

(27.6; 50.4)

65.9%

(56.8; 74.2)

30.2

(20.2; 45.0)

(Post-

booster)

(2,3)

100%

(98.3; 100)

4585

(4129; 5093)

100%

(97.9; 100)

6776

(5961; 7701)

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Table 10:

rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in

toddlers aged 12-23 months, persistence at 4 years and response following a booster 4 years after

initial vaccination, and persistence up to 6 years following booster vaccination (Studies

MenACWY-TT-039/048/102)

Meningo

-coccal

group

Vaccine

group

Time point

rSBA*

hSBA**

N

≥8

(95% CI)

GMT

(95% CI)

N

≥8

(95% CI)

GMT

(95% CI)

5 years after

booster dose

92.7%

(87.0; 96.4)

(191; 368)

97.8%

(93.7; 99.5)

(321; 495)

6 years after

booster dose

94.0%

(88.6; 97.4)

(189; 359)

97.7%

(93.5; 99.5)

(253; 394)

The analysis of immunogenicity was conducted on the ATP cohort for each time point.

(1) Study MenACWY-TT-039

(2) Study MenACWY-TT-048

(3) Blood sampling was performed 1 month after a booster dose at Year 4.

(4) Study MenACWY-TT-102

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE

laboratories in UK for the subsequent sampling time points.

**hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in Study

MenACWY-TT-102.

In study MenACWY-TT-088, the persistence of SBA titres was evaluated up to 68 months

after vaccination in children 2-10 years of age initially vaccinated in Study MenACWY-TT-

081. Results are show in Table 11 below.

Table 11: rSBA and hSBA titres up to 68 months following NIMENRIX (or MenC-CRM) in

children aged 2-10 years of age at time of vaccination (Study MenACWY-TT-088)

Menin

gococc

al

group

Vaccine

group

Time-

point

(months)

rSBA*

hSBA**

N

≥8

(95%CI)

GMT

(95%CI)

N

***

≥8

(95%CI)

GMT

(95%CI)

A

NIMENRIX

86.5%

(80.9; 91.0)

(144; 267)

25.6%

(16.9; 35.8)

(3.3; 6.3)

86.5% (80.6;

91.2)

(93.5; 179)

40.6%

(33.1; 48.4)

(5.4; 8.9)

C

NIMENRIX

64.6%

(57.4; 71.3)

34.8

(26.0; 46.4)

95.6%

(89.0; 98.8)

75.9

(53.4; 108)

39.9% (32.6;

47.5)

14.2

(10.8; 18.7)

75.6%

(68.5; 81.8)

28.4

(21.2; 37.9)

MenC-CRM

vaccine

76.8%

(65.1; 86.1)

86.5

(47.3; 158)

90.9%

(75.7; 98.1)

82.2

(34.6; 196)

62.3% (49.0;

74.4)

44.5

(23.7; 83.6)

75.4%

(62.2; 85.9)

34.3

(19.0; 61.9)

W-135

NIMENRIX

77.2%

(70.6; 82.9)

(149; 307)

84.9%

(75.5; 91.7)

69.9

(48.2; 101)

52.8%

(45.2; 60.3)

59.2

(39.3; 89.2)

78.6%

(71.4; 84.7)

56.7

(41.5; 77.3)

Y

NIMENRIX

81.3%

(75.1; 86.6)

(165; 314)

81.3%

(71.8; 88.7)

79.2

(52.5; 119)

71.3%

(64.1; 77.9)

(96.0; 202)

73.0%

(65.3; 79.7)

56.3

(39.5; 80.3)

The analysis of immunogenicity was conducted on the ATP cohort for persistence adapted for each time-point.

*rSBA analysis performed at PHE laboratories in UK

** hSBA analysis performed at GSK laboratories

*** at Month 32, a subset of subjects has been tested for hSBA

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In Study MenACWY-TT-028, the persistence of hSBA titres was evaluated 1 year after

vaccination in children aged 6-10 years of age who were initially vaccinated with either

NIMENRIX or ACWY-PS vaccine in Study MenACWY-TT-027. Results are shown in

Table 12.

Table 12: hSBA* titres following a single dose of NIMENRIX (or ACWY-PS in children aged

6-10 and persistence 1 year following vaccination (Studies MenACWY-TT-027/028)

Mening

ococcal

group

Vaccine

group

1

month

postvaccination

(Study

MenACWY-TT-027)

1 year persistence (Study MenACWY-

TT-028)

(95%CI)

(95%CI)

(95%CI)

(95%CI)

A

NIMENRIX

80.0 %

(71.1; 87.2)

53.4

(37.3; 76.2)

16.3%

(9.8; 24.9)

(2.7; 4.4)

ACWY-PS

vaccine

25.7%

(12.5;43.3)

(2.6;6.5)

5.7%

(0.7;19.2)

(1.9;3.3)

C

NIMENRIX

89.1%

(81.3;94.4)

(99.3;244)

95.2%

(89.2;98.4)

(95.4;176)

ACWY-PS

vaccine

39.5%

(24.0;56.6)

13.1

(5.4;32.0)

32.3%

(16.7;51.4)

(3.5;17.3)

W-135

NIMENRIX

95.1%

(89.0;98.4)

(99.9;178)

100%

(96.5;100)

(218;302)

ACWY-PS

vaccine

34.3%

(19.1;52.2)

(3.3;9.9)

12.9%

(3.6;29.8)

(2.0;5.8)

Y

NIMENRIX

83.1%

(73.7;90.2)

95.1

(62.4;145)

99.1%

(94.9;100)

(213;330)

ACWY-PS

vaccine

43.8%

(26.4;62.3)

12.5

(5.6;27.7)

33.3%

(18.6;51.0)

(4.3;19.9)

The analysis of immunogenicity was conducted on the ATP cohort for persistence at Year 1.

hSBA analysis was not performed for children aged 2 to <6 years (at time of vaccination).

* hSBA analysis performed at GSK laboratories

SBA titres were determined over a period of 10 years in children initially vaccinated with

one dose of NIMENRIX or ACWY-PS at 2 to 10 years of age in Study MenACWY-TT-027.

Persistence of SBA titres was evaluated in two extension studies: MenACWY-TT-032 (up

to 5 years) and MenACWY-TT-100 (up to 10 years). Study MenACWY-TT-100 also

evaluated the response to a single booster dose of NIMENRIX administered 10 years

following the initial vaccination with NIMENRIX or ACWY-PS. Results are shown in Table

13 (see section 4.4 Special warnings and precautions for use).

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Page 21 of 30

Table 13:

rSBA and hSBA titres following a single dose of NIMENRIX (or ACWY-PS) in children aged

2- 10 years, persistence up to 10 years, and post-booster administered 10 years following initial

vaccination (Studies MenACWY-TT-027/032/100)

Meningo-

coccal

group

Vaccine

group

Time point

rSBA*

hSBA**

N

≥8

(95% CI)

GMT

(95% CI)

N

≥8

(95% CI)

GMT

(95% CI)

A

NIMENR

IX

Month 1

100%

(98.4; 100)

7301

(6586; 8093)

81.1%

(72.5; 87.9)

57.0

(40.3; 80.6)

Year 5

90.8%

(83.3; 95.7)

(98.2; 203)

Year 6

79.6%

(70.3; 87.1)

(66.0; 174)

41.1%

(30.8; 52.0)

(4.8; 8.8)

Year 10

(Pre-booster)

89.0%

(79.5; 95.1)

96.3

(57.1; 163)

33.9%

(22.3; 47.0)

(3.3; 6.2)

(Post-booster)

(3,4)

95.9%

(88.6; 99.2)

4626

(3041; 7039)

100%

(95.1; 100)

1213

(994; 1481)

ACWY-

PS

vaccine

Month 1

100%

(95.2; 100)

2033

(1667; 2480)

25.7%

(12.5; 43.3)

(2.6; 6.5)

Year 5

15.4%

(1.9; 45.4)

(3.7; 6.0)

Year 6

12.5%

(2.7; 32.4)

(3.5; 9.6)

33.3%

(14.6; 57.0)

(3.0; 11.7)

Year 10

(Pre-booster)

23.5%

(6.8; 49.9)

(3.3; 19.3)

29.4%

(10.3; 56.0)

(2.4; 15.7)

(Post-booster)

(3,4)

100%

(80.5; 100)

6414

(3879; 10608)

100%

(80.5; 100)

(131; 340)

C

NIMENR

IX

Month 1

100%

(98.4; 100)

2435

(2106; 2816)

89.7%

(82.3; 94.8)

(101; 237)

Year 5

90.8%

(83.3; 95.7)

79.7

(56.0; 113)

Year 6

82.7%

(73.7; 89.6)

(121; 308)

93.8%

(87.0; 97.7)

(261; 700)

Year 10

(Pre-booster)

85.1%

(75.0; 92.3)

(106; 310)

91.8%

(83.0; 96.9)

(129; 380)

(Post-booster)

(3,4)

100%

(95.1; 100)

4020

(3319; 4869)

100%

(94.9; 100)

15544

(11735; 20588)

ACWY-

PS

vaccine

Month 1

100%

(95.1; 100)

(555; 1014)

39.5%

(24.0; 56.6)

13.1

(5.4; 32.0)

Year 5

100%

(75.3; 100)

(56.4; 291)

Year 6

79.2%

(57.8; 92.9)

98.7

(42.2; 231)

100%

(85.8; 100)

(122; 451)

Year 10

(Pre-booster)

76.5%

(50.1; 93.2)

96.2

(28.9; 320)

100%

(80.5; 100)

99.1

(35.8; 274)

(Post-booster)

(3,4)

100%

(80.5; 100)

15101

(7099; 32122)

94.1

(71.3; 99.9)

44794

(10112; 198440)

W-135

NIMENR

IX

Month 1

100%

(98.4; 100)

11777

(10666; 13004)

95.3%

(89.4; 98.5)

(101; 178)

Year 5

78.6%

(69.1; 86.2)

(128; 340)

Year 6

73.5%

(63.6; 81.9)

(155; 454)

81.5%

(72.1; 88.9)

62.5

(42.0; 93.1)

Year 10

(Pre-booster)

68.9%

(57.1; 79.2)

(109; 392)

61.0%

(47.4; 73.5)

17.5

(10.5; 29.2)

(Post-booster)

(3,4)

100%

(95.1; 100)

27944

(22214; 35153)

100%

(95.1; 100)

6965

(5274; 9198)

Month 1

100%

(95.2; 100)

2186

(1723; 2774)

34.3%

(19.1; 52.2)

(3.3, 9.9)

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Page 22 of 30

Table 13:

rSBA and hSBA titres following a single dose of NIMENRIX (or ACWY-PS) in children aged

2- 10 years, persistence up to 10 years, and post-booster administered 10 years following initial

vaccination (Studies MenACWY-TT-027/032/100)

ACWY-

PS

vaccine

Year 5

(0.0; 24.7)

(4.0; 4.0)

Year 6

12.5%

(2.7; 32.4)

(3.7; 15.6)

30.4%

(13.2; 52.9)

(2.9; 16.9)

Year 10

(Pre-booster)

23.5%

(6.8; 49.9)

15.4

(4.2; 56.4)

26.7%

(7.8; 55.1)

(2.0; 8.5)

(Post-booster)

(3,4)

94.1%

(71.3; 99.9)

10463

(3254; 33646)

100%

(78.2; 100)

(101; 395)

Y

NIMENR

IX

Month 1

100%

(98.4; 100)

6641

(6044; 7297)

83.0%

(73.8; 89.9)

93.7

(62.1; 141)

Year 5

78.6%

(69.1; 86.2)

(88.0; 233)

Year 6

71.4%

(61.4; 80.1)

(82.6; 225)

65.2%

(54.3; 75.0)

40.3

(23.9; 68.1)

Year 10

(Pre-booster)

67.6%

(55.7; 78.0)

98.5

(54.3; 179)

72.3%

(59.8; 82.7)

35.7

(21.0; 60.6)

(Post-booster)

(3,4)

100%

(95.1; 100)

7530

(5828; 9729)

100%

(95.1; 100)

11127

(8909; 13898)

ACWY-

PS

vaccine

Month 1

100%

(95.2; 100)

1410

(1086; 1831)

43.8%

(26.4; 62.3)

12.5

(5.6; 27.7)

Year 5

7.7%

(0.2; 36.0)

(2.7; 11.1)

Year 6

20.8%

(7.1; 42.2)

11.6

(4.7; 28.7)

25.0%

(9.8; 46.7)

(2.7; 19.8)

Year 10

(Pre-booster)

17.6%

(3.8; 43.4)

10.2

(3.5; 30.2)

35.7%

(12.8; 64.9)

(2.5; 24.4)

(Post-booster)

(3,4)

100%

(80.5; 100)

6959

(3637; 13317)

100%

(80.5; 100)

(215; 960)

The analysis of immunogenicity was conducted on the ATP cohort for each time point.

Study MenACWY-TT-027

Study MenACWY-TT-032

Study MenACWY-TT-100

Blood sampling was performed 1 month after a booster dose at Year 10.

Includes children aged 6 to <11 years. hSBA analysis was not performed for children aged 2 to <6 years

(at time of vaccination).

Per the protocol for Study MenACWY-TT-032, hSBA was not measured for this age group at Year 5.

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE

laboratories in UK for subsequent sampling time points.

**hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in Study

MenACWY-TT-100.

rSBA titres were determined over a period of 10 years in subjects initially vaccinated with

one dose of NIMENRIX or ACWY-PS at 11 to 17 years of age in Study MenACWY-TT-

036. Persistence of rSBA titres was evaluated in two extension studies: MenACWY-TT-043

(up to 5 years) and MenACWY-TT-101 (at 10 years). Study MenACWY-TT-101 also

evaluated the response to a single booster dose of NIMENRIX administered 10 years

following the initial vaccination with NIMENRIX or ACWY-PS.

Results are shown in Table

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Page 23 of 30

Table 14: rSBA* titres following a single dose of NIMENRIX (or ACWY-PS) in adolescents

aged 11-17 years, persistence up to 10 years, and post-booster administered 10 years

following initial vaccination (Studies MenACWY-TT-036/043/101)

Mening

ococcal

group

Time-

point

NIMENRIX

ACWY-PS vaccine

N

≥8

(95%CI)

GMT

(95%CI)

N

≥8

(95%CI)

GMT

(95%CI)

Month

100%

(99.5; 100)

5929

(5557;

6324)

99.6%

(97.5; 100)

2947

(2612; 3326)

Year 3

92.9%

(90.1; 95.1)

(381; 527)

82.7%

(75.6; 88.4)

(147; 288)

Year 5

97.5 %

(94.5; 99.1)

(531; 781)

93.0

(85.4; 97.4)

(202; 433)

Year

(Pre-

booster)

85.2%

(78.8; 90.3)

(181; 340)

80.4%

(66.9; 90.2)

(80.5; 253)

(Post-

booster)

3,4)

100%

(97.7; 100)

3760

(3268;

4326)

100%

(93.0; 100)

2956

(2041; 4282)

Month

100%

(99.5; 100)

13110

(11939;

14395)

100%

(98.4; 100)

8222

(6808; 9930)

Year 3

91.1%

(88.1; 93.6)

(309; 446)

86.0%

(79.4; 91.1)

(262; 580)

Year 5

88.6 %

(83.8; 92.3)

(194; 318)

87.1

(78.0; 93.4)

(224; 599)

Year

(Pre-

booster)

90.1%

(84.5; 94.2)

(182; 329)

82.4%

(69.1; 91.6)

(86.1; 365)

(Post-

booster)

3,4)

100%

(97.7; 100)

8698

(7391

10235)

100%

(93.0; 100)

3879

(2715; 5544)

W-135

Month

99.9%

(99.2; 100)

8247

(7639;

8903)

100%

(98.4; 100)

2633

(2299; 3014)

Year 3

82.0%

(78.1; 85.4)

(268; 426)

30.0%

(22.8; 38.0)

16.0

(10.9; 23.6)

Year 5

86.0%

(80.9; 90.2)

(324; 588)

34.9

(24.9; 45.9)

19.7

(11.8; 32.9)

Year

(Pre-

booster)

71.6%

(64.0; 78.4)

(97.6; 217)

43.1%

(29.3; 57.8)

16.4

(9.2; 29.4)

(Post-

booster)

3,4)

100%

(97.7; 100)

11243

(9367;

13496)

100%

(93.0; 100)

3674

(2354; 5734)

Month

100%

(99.5; 100)

14087

(13168;

15069)

100%

(98.4; 100)

5066

(4463; 5751)

Year 3

93.1%

(90.3; 95.3)

(620; 884)

58.0%

(49.7; 66.0)

69.6

(44.6; 109)

Year 5

96.6%

(93.4; 98.5)

1000

(824; 1214)

66.3

(55.3; 76.1)

(71.2; 219)

Year

(Pre-

booster)

90.7%

(85.2; 94.7)

(333; 599)

49.0%

(34.8; 63.4)

32.9

(17.1; 63.3)

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Page 24 of 30

(Post-

booster)

3,4)

100%

(97.7; 100)

7585

(6748;

8525)

98.0%

(89.6; 100)

3296

(1999; 5434)

The analysis of immunogenicity was conducted on the ATP cohort for each time point.

(1) Study MenACWY-TT-036

(2) Study MenACWY-TT-043

(3) Study MenACWY-TT-101

(4) Blood sampling was performed 1 month after a booster dose at Year 10.

* rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE

laboratories in UK for the subsequent sampling time points.

Study

MenACWY-TT-059,

hSBA

persistence

evaluated

years

after

vaccination in adolescents and adults aged 11-25 years initially vaccinated in Study

MenACWY-TT-052.

For all meningococcal groups, the persistence of hSBA titres elicited by NIMENRIX was

similar to or higher than those induced by the ACWY-DT vaccine as shown in Table 15.

Table 15: hSBA* titres following a single dose of NIMENRIX (or ACWY-DT) in adolescents

and

adults

aged

11-25

years

and

persistence

up

to

5

years

following

vaccination

(Studies MenACWY-TT-052/059)

Meningococcal

group

Vaccine

group

Timepoint

N

8 (95%CI)

GMT (95%CI)

NIMENRIX

Month 1

82.0% (77.6; 85.9)

58.7 (48.6; 70.9)

Year 1

29.1% (24.4; 34.2)

5.4 (4.5; 6.4)

Year 5

48.9 % (40.4; 57.5)

8.9 (6.8; 11.8)

ACWY-DT

Month 1

73.8% (64.4; 81.9)

42.5 (28.5; 63.3)

Year 1

31.5% (23.0; 41.0)

6.0 (4.3; 8.5)

Year 5

44.4% (29.6; 60.0)

7.9 (4.8; 13.2)

NIMENRIX

Month 1

96.1% (93.5; 97.9)

532 (424; 668)

Year 1

94.9% (92.0; 97.0)

172 (142; 207)

Year 5

92.9% (87.3; 96.5)

94.6 (65.9; 136)

ACWY-DT

Month 1

99.1% (95.2; 100)

317 (217; 462)

Year 1

73.3% (63.8; 81.5)

46.7 (30.2; 72.1)

Year 5

79.5% (64.7; 90.2)

30.6 (17.3; 54.4)

W-135

NIMENRIX

Month 1

91.0% (87.4; 93.9)

117 (96.8; 141)

Year 1

98.5% (96.5; 99.5)

197 (173; 225)

Year 5

87.0% (80.2; 92.1)

103 (76.3; 140)

ACWY-DT

Month 1

75.0% (65.1; 83.3)

70.4 (43.7; 113)

Year 1

75.7% (66.5; 83.5)

48.9 (32.5; 73.8)

Year 5

84.1% (69.9; 93.4)

70.4 (37.2; 133)

NIMENRIX

Month 1

95.1% (92.3; 97.0)

246 (208; 291)

Year 1

97.8% (95.6; 99.0)

272 (237; 311)

Year 5

94.4% (89.2; 97.5)

225 (174; 290)

ACWY-DT

Month 1

81.1% (72.5; 87.9)

103 (67.5; 159)

Year 1

86.6% (78.9; 92.3)

101 (69.6; 146)

Year 5

90.9% (78.3; 97.5)

129 (77.4; 216)

The analysis of immunogenicity was conducted on the ATP cohort for persistence adapted for each time

point.

(1) Study MenACWY-TT-052

(2) Study MenACWY-TT-059

* hSBA analysis performed at GSK laboratories

rSBA titres were determined over a period of 10 years in subjects initially vaccinated with

one dose of NIMENRIX or ACWY-PS at 11 to 55 years of age in Study MenACWY-TT-

015. Persistence of rSBA titres was evaluated in two extension studies: MenACWY-TT-

020 (up to 5 years) and MenACWY-TT-099 (up to 10 years). Study MenACWY-TT-099

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Page 25 of 30

also evaluated the response to a single booster dose of NIMENRIX administered 10 years

following the initial vaccination with NIMENRIX or ACWY-PS.

Results are shown in

Table 16.

Table 16: rSBA* titres following a single dose of NIMENRIX or ACWY-PS in adolescents and

adults aged 11-55 years, persistence up to 10 years, and post-booster administered 10 years

following initial vaccination (Studies MenACWY-TT-015/020/099

Meningo-

coccal

group

Time point

NIMENRIX

ACWY-PS vaccine

N

≥8

(95% CI)

GMT

(95% CI)

N

≥8

(95% CI)

GMT

(95% CI)

A

Month 1

100%

(98.9; 100)

4945

(4452, 5493)

100%

(96.8, 100)

2190

(1858, 2582)

Year 4

95.3%

(84.2; 99.4)

(226; 590)

76.5%

(50.1; 93.2)

(31.0; 351)

Year 5

84.3%

(71.4; 93.0)

(108; 335)

57.9%

(33.5; 79.7)

37.0

(12.6; 109)

Year 10

(Pre-booster)

78.1%

(70.7; 84.3)

(108; 219)

71.2%

(56.9; 82.9)

75.1

(41.4; 136)

(Post-

booster)

(3,4)

100%

(97.6; 100)

4060

(3384; 4870)

100%

(93.2; 100)

3585

(2751; 4672)

C

Month 1

99.7%

(98.4; 100)

10074

(8700, 11665)

100%

(96.8; 100)

6546

(5048; 8488)

Year 4

76.7%

(61.4; 88.2)

(61.6; 258)

41.2%

(18.4; 67.1)

16.7

(5.7; 48.7)

Year 5

72.5%

(58.3; 84.1)

78.5

(41.8; 147)

38.9%

(17.3; 64.3)

17.3

(6.0; 49.7)

Year 10

(Pre-booster)

90.9%

(85.2; 94.9)

(141; 264)

88.5%

(76.6; 95.6)

(110; 412)

(Post-

booster)

(3,4)

100%

(97.6; 100)

13824

(10840; 17629)

98.1%

(89.7; 100)

3444

(1999; 5936)

W-135

Month 1

99.7%

(98.4; 100)

8577

(7615; 9660)

100%

(96.8; 100)

2970

(2439; 3615)

Year 4

90.7%

(77.9; 97.4)

(128; 450)

17.6%

(3.8; 43.4)

(3.6; 19.5)

Year 5

86.3%

(73.7; 94.3)

(146; 543)

31.6%

(12.6; 56.6)

15.4

(5.7; 41.9)

Year 10

(Pre-booster)

71.4%

(63.6; 78.4)

(107; 258)

21.2%

(11.1; 34.7)

10.9

(6.1; 19.3)

(Post-

booster)

(3,4)

100%

(97.6; 100)

23431

(17351; 31641)

98.1%

(89.7; 100)

5793

(3586; 9357)

Y

Month 1

100%

(98.9; 100)

10315

(9317; 11420)

100%

(96.8; 100)

4574

(3864; 5414)

Year 4

86.0%

(72.1; 94.7)

(230; 853)

47.1%

(23.0; 72.2)

30.7

(9.0; 105)

Year 5

92.2%

(81.1; 97.8)

(439; 1351)

63.2%

(38.4; 83.7)

74.1

(21.9; 250)

Year 10

(Pre-booster)

86.4%

(79.9; 91.4)

(255; 519)

61.5%

(47.0; 74.7)

56.0

(28.8; 109)

(Post-

booster)

(3,4)

100%

(97.6; 100)

8958

(7602; 10558)

100%

(93.2; 100)

5138

(3528; 7482)

The analysis of immunogenicity was conducted on the ATP cohorts for 1 month and 5 years post vaccination

and the booster ATP cohort.

Study MenACWY-TT-015

(2) Study MenACWY-TT-020

(3) Study MenACWY-TT-099

(4) Blood sampling was performed 1 month after a booster dose at Year 10.

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE

laboratories in UK for the subsequent sampling time points.

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In a descriptive study conducted in 194 adults aged 56 years and older (Study MenACWY-

TT-085), NIMENRIX was immunogenic, with a vaccine response rate ≥ 63.4% and with ≥

97.4% of subjects with rSBA titres ≥ 8 against all four meningococcal groups. Moreover, at

least 93.2% of subjects achieved the more conservative threshold of protection of rSBA

titres ≥ 128.

Immune memory

In Study MenACWY-TT-014, the induction of immune memory was assessed 1 month after

the administration of a fifth of the dose of ACWY-PS vaccine (10 µg of each polysaccharide)

to children in the third year of life. These children were initially vaccinated in study

MenACWY-TT-013 with either NIMENRIX or a licensed MenC-CRM vaccine at the age of

12 to 14 months.

One month after the challenge dose, the GMTs elicited by the subjects initial vaccination

with NIMENRIX increased 6.5 to 8-fold, indicating that NIMENRIX induces immune

memory to all four groups A, C, W-135 and Y. The post-challenge rSBA-MenC GMT was

similar in both study groups, indicating that NIMENRIX induces an analogous immune

memory to group C as the licensed MenC-CRM vaccine. Results are shown in Table 17.

Table 17: rSBA* titres 1 month after a challenge vaccination in subjects initially vaccinated

with NIMENRIX or a MenC-CRM vaccine at the age of 12 to 14 months (Study MenACWY-

TT-014)

Meningococcal

group

Vaccine group

Pre-challenge

Post-challenge

(95%CI)

(95%CI)

A

NIMENRIX

(325; 911)

3322

(2294; 4810)

C

NIMENRIX

(105; 289)

5966

(4128; 8621)

MenC-CRM

34.4

(15.8; 75.3)

5265

(3437; 8065)

W-135

NIMENRIX

(394; 1052)

11058

(8587; 14240)

Y

NIMENRIX

(274; 706)

5737

(4216; 7806)

The analysis of immunogenicity was conducted on the ATP cohort.

* rSBA analysis performed at GSK laboratories

Booster response for subjects previously vaccinated with a conjugate meningococcal vaccine

against Neisseria meningitidis

NIMENRIX booster vaccination in subjects previously primed with a monovalent (MenC-

CRM) or a quadrivalent conjugate meningococcal vaccine (MenACWY-TT) was studied in

subjects from 12 months of age onwards who received a booster vaccination. Robust

anamnestic responses to the antigen(s) in the priming vaccine were observed (see Tables 9,

10, 13, 14, and 15).

Response to NIMENRIX in subjects previously vaccinated with a plain polysaccharide

meningococcal vaccine against Neisseria meningitidis

Study

MenACWY-TT-021

conducted

subjects

aged

years,

immunogenicity of NIMENRIX administered between 30 and 42 months after vaccination

with

ACWY-PS

vaccine

compared

immunogenicity

NIMENRIX

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Page 27 of 30

administered to age-matched subjects who had not been vaccinated with any meningococcal

vaccine in the preceding 10 years. The rSBA GMTs were significantly lower in the subjects

who had received a dose of ACWY-PS vaccine 30-42 months prior to NIMENRIX . The

clinical relevance of this observation is unknown since all subjects achieved rSBA titres ≥ 8

for all four meningococcal groups regardless of meningococcal vaccination history. Results

are shown in Table 18.

Table 18: rSBA* titres 1 month after NIMENRIX vaccination in subjects according to their

meningococcal vaccine history (Study MenACWY-TT-021)

Mening

ococcal

group

Subjects vaccinated 30 to 42 months

previously with ACWY-PS

Subjects who had not received a

meningococcal vaccine in the preceding

10 years

N

≥8

(95%CI)

GMT

(95%CI)

N

≥8

(95%CI)

GMT

(95%CI)

100%

(97.5; 100)

6869

(6045; 7805)

100%

(94.8; 100)

13015

(10722; 15798)

100%

(97.8; 100)

1946

(1583; 2391)

100%

(95.2; 100)

5495

(4266; 7076)

W-135

100%

(97.8; 100)

4636

(3942; 5451)

100%

(95.2; 100)

9078

(7088; 11627)

100%

(97.8; 100)

7800

(6683; 9104)

100%

(95.2; 100)

13895

(11186; 17261)

The analysis of immunogenicity was conducted on the ATP cohort.

* rSBA analysis performed at GSK laboratories

Response to NIMENRIX in subjects at increased risk for meningococcal infections

Study

MenACWY-TT-084

evaluated

immunogenicity

doses

NIMENRIX given two months apart in 43 at-risk subjects aged 2-17 years (at increased risk

for meningococcal disease, i.e., asplenic subjects, and hyposplenic subjects) compared to 43

healthy age-matched subjects.

One month after the first vaccine dose, vaccine response rates (rSBA titre ≥1:32 or a ≥4-fold

increase in rSBA titre from baseline) for groups A, C, W-135, and Y, respectively, were

100%, 92.5%, 100% and 97.5% in the at-risk group and were 97.5%, 97.5%, 97.5%, and

100% for healthy subjects. After the second vaccine dose, vaccine response rates in both

at-risk and healthy subjects were 100% for each of the four meningococcal groups.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on local tolerance, acute

toxicity, repeated dose toxicity, developmental/reproductive toxicity and fertility studies.

The carcinogenic potential of NIMENRIX has not been investigated.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

The powder for reconstitution contains the excipients trometamol and sucrose. The diluent

contains 0.9% sodium chloride in water for injections. No preservative or adjuvant is added.

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6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other

medicinal products.

6.3 Shelf Life

The shelf-life of NIMENRIX is four years from the date of manufacture when stored at

temperatures between 2°C to 8°C. The expiry date of the vaccine is marked on the label and

packaging. After reconstitution, the vaccine should be used promptly.

shelf-life

after

reconstitution

medicinal

product

(see

Section

Special

precautions for disposal and other handling).

6.4 Special Precautions for Storage

NIMENRIX must be stored between 2°C to 8°C. The sterile 0.9% saline diluent may be

refrigerated or stored at ambient temperatures, but must not be frozen. The vaccine should

be stored in the original package in order to protect from light.

6.5 Nature and Contents of Container

NIMENRIX is supplied in a glass vial (type 1 glass) with a stopper (butyl rubber), together

with 0.5mL solvent in a pre-filled syringe with a stopper (butyl rubber).

Pack sizes of 1 and 10 with or without separate needles.

Not all pack sizes or presentations may be marketed.

6.6 Special Precautions for Disposal and Other Handling

Instructions for reconstitution of the vaccine with the solvent presented in pre-filled

syringe

NIMENRIX must be reconstituted by adding the entire contents of the pre-filled syringe of

solvent to the vial containing the powder.

To attach the needle to the syringe, refer to the below picture.

Needle

Syringe

Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the

syringe cap by twisting it anticlockwise.

Needle protector

Syringe plunger

Syringe barrel

Syringe cap

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To attach a screw-thread needle to the syringe, twist the needle clockwise into the syringe

until you feel it lock (see picture). A needle without a screw-thread may also be used. In this

case, the needle should be attached without screwing.

Remove the needle protector, which on occasion can be a little stiff.

Add the solvent to the powder. After the addition of the solvent to the powder, the mixture

should be well shaken until the powder is completely dissolved in the solvent.

The reconstituted vaccine is a clear colourless solution.

The reconstituted vaccine should be inspected visually for any foreign particulate matter

and/or variation of physical aspect prior to administration. In the event of either being

observed, discard the vaccine.

After

reconstitution,

vaccine

should

used

promptly.

Although

delay

recommended, stability has been demonstrated for 8 hours at 30°C after reconstitution. If not

used within the 8 hours, do not administer the vaccine.

A new needle should be used to administer the vaccine.

Any unused product or waste material should be disposed of in accordance with local

requirements.

7. MEDICINE SCHEDULE

Prescription medicine; except when administered to a person 16 years of age or over by a

registered pharmacist who has successfully completed a vaccinator training course approved

by the Ministry of Health and who is complying with the immunisation standards of the

Ministry of Health.

8. SPONSOR

Pfizer New Zealand Limited

P O Box 3998 Auckland, New Zealand, 1140.

Toll Free Number: 0800 736 363

9. DATE OF FIRST APPROVAL

16 October 2014

10. DATE OF REVISION OF TEXT

10 May 2021

= Registered Trade Mark

NIMENRIX

is a registered trademark of GlaxoSmithKline Biologicals SA, licensed to

Pfizer Inc.

SUMMARY TABLE OF CHANGES

Section Changed

Summary of new information

Update to shelf-life

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6.5, 6.6

Removal of information relating to the ampoule presentation

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