Boostrix-IPV

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Diphtheria toxoid, adsorbed 2 IU (2.5LfU); Pertactin 2.5 µg; Pertussis filamentous haemagglutinin 8 µg; Pertussis toxoid, adsorbed 8 µg;  ; Polio virus type 1 40 DAgU; Polio virus type 2 8 DAgU; Polio virus type 3 32 DAgU; Tetanus toxoid 20 IU (5LfU)
Available from:
GlaxoSmithKline (NZ) Ltd
INN (International Name):
Diphtheria toxoid, adsorbed 2.5 Lf U (2IU)
Dosage:
0.5 mL
Pharmaceutical form:
Suspension for injection
Composition:
Active: Diphtheria toxoid, adsorbed 2 IU (2.5LfU) Pertactin 2.5 µg Pertussis filamentous haemagglutinin 8 µg Pertussis toxoid, adsorbed 8 µg   Polio virus type 1 40 DAgU Polio virus type 2 8 DAgU Polio virus type 3 32 DAgU Tetanus toxoid 20 IU (5LfU) Excipient: Aluminium Sodium chloride Water for injection
Units in package:
Syringe, glass, 0.5mL, 1 dose unit
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
GSK Vaccines GmbH
Therapeutic indications:
BOOSTRIX®-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of four years onwards. BOOSTRIX®-IPV is not intended for primary immunisation.
Product summary:
Package - Contents - Shelf Life: Syringe, glass, 0.5mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours not refrigerated stored below 21°C - Syringe, glass, 10 x 0.5mL doses - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours not refrigerated stored below 21°C
Authorization number:
TT50-6346/1
Authorization date:
2003-07-18

BOOSTRIX

-IPV

Combined diphtheria-Tetanus-acellular pertussis (dTpa) and Inactivated Poliovirus

Vaccine

CONSUMER MEDICINE INFORMATION LEAFLET

WHAT IS IN THIS LEAFLET

This leaflet answers some of the common questions about BOOSTRIX-IPV vaccine. It does not

contain all the available information. It does not take the place of talking to your doctor, nurse or

pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the possible

risks of having BOOSTRIX-IPV against the expected benefits.

If you have any concerns about receiving BOOSTRIX-IPV talk to your doctor, nurse or

pharmacist.

Keep this leaflet with this vaccine. You may need to read it again

WHAT BOOSTRIX-IPV IS USED FOR

BOOSTRIX-IPV is a vaccine used as a booster to prevent four diseases, diphtheria, tetanus,

pertussis (whooping cough) and poliomyelitis (polio) in adults and children aged 4 years and older

who have been previously vaccinated against these diseases. The vaccine works by causing the

body to produce its own protection (antibodies) against these diseases.

Diphtheria, tetanus, and pertussis are all serious life-threatening diseases caused by bacterial

infection. Poliomyelitis is an infectious diseases caused by viral infection.

Diphtheria

Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become

inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The

bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and

death. The risk of serious complications and death is greater in the very young and elderly.

Tetanus (Lockjaw)

Tetanus bacteria enter the body through wounded skin. Wounds that are especially prone to

infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse

manure or wood splinters. The bacteria release a toxin (poison), which can cause muscle

stiffness, painful muscle spasms, fits and death. The spasms can be strong enough to cause

bone fractures of the spine. The death rate is 10% of cases.

Pertussis (Whooping cough)

Pertussis is a highly infectious illness. The disease affects the breathing tract causing severe

spells

coughing

that

interfere

with

normal

breathing.

coughing

often

accompanied by a ‘whooping’ sound. The cough may last for 1-2 months or longer. Pertussis

can also cause middle ear infections, long-lasting bronchitis, pneumonia, fits, brain damage

and death. The risk of severe complications and death is greatest in infants under 6 months of

age. The death rate is 0.5% for infants under 6 months of age.

Poliomyelitis (Polio)

Polio is a viral infection that can have variable effects. Often it causes only a mild

illness but in some people it causes permanent injury or death.

In its severest form, polio infection causes paralysis of the muscles, including those needed for

breathing and walking. Polio infection can leave a person unable to breathe without the help

of an iron lung machine, unable to walk without leg braces, or confined to a wheel chair. The

limbs affected by the disease may be painfully deformed.

Vaccination is the best way to protect against these diseases. BOOSTRIX-IPV vaccine cannot

give you or your child diphtheria, tetanus, pertussis or polio infection. The vaccine will not protect

against diseases caused by other types of bacteria, viruses or organisms.

A primary course of tetanus, diphtheria, pertussis and polio vaccine is usually given during early

childhood with doses given at 2, 4, 6 and one further dose at 4 years of age.

BEFORE VACCINATION

BOOSTRIX-IPV SHOULD NOT BE GIVEN IF:

you or your child has had an allergic reaction to BOOSTRIX-IPV, or any ingredient contained

in this vaccine. The ingredients in BOOSTRIX-IPV are listed at the end of this leaflet. Signs

of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the

face or tongue.

If you or your child had BOOSTRIX-IPV before and became unwell, tell your doctor, nurse or

pharmacist before the next dose is given.

you or your child experienced a disease of the brain within 7 days after previous vaccination

with a pertussis containing vaccine.

you or your child had a low blood platelet count or bled or bruised more easily following earlier

immunisation against diphtheria and/or tetanus even if only for a short time

you or your child has had an allergic reaction to any other diphtheria, tetanus, pertussis or

inactivated polio containing vaccine (such as INFANRIX

, Triple Antigen™, Tripacel™ or

IPOL™ vaccine).

you or your child suffered from problems associated with your nervous system following earlier

immunisation against diphtheria and/or tetanus even if only for a short time

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 to your doctor or nurse about this before vaccination.

you or your child has not received a complete course of diphtheria or tetanus vaccine

previously.

you or your child suffer from neurological disorders, including infantile spasms, uncontrolled

epilepsy or progressive encephalopathy (a brain disease).

the expiry date printed on the pack has passed.

the packaging is torn or shows signs of tampering.

If you are not sure whether your child should have BOOSTRIX-IPV vaccine, talk to your

doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it

specifically for you/your child.

BEFORE BOOSTRIX-IPV IS GIVEN TELL YOUR DOCTOR OR NURSE IF:

you or your child has any medical problems such as:

brain disease or central nervous system (CNS) disease (ie. epilepsy etc.)

a bleeding problem or bruises easily

lowered immunity due to medical treatment or a medical condition

a tendency to febrile convulsions (seizures/fits due to a fever or high body temperature)

a family history of Sudden Infant Death Syndrome (SIDS)

allergy to the antibiotics: neomycin sulfate and polymyxin sulfate.

you or your child has not previously received the full course of diphtheria and tetanus

vaccination. BOOSTRIX-IPV will not work in this situation.

after having BOOSTRIX-IPV or another pertussis-containing vaccine (such as INFANRIX

Triple Antigen™) you or your child had any problems, especially:

a high temperature (40.0

C) within 2 days of vaccination

a collapse or shock-like state within 2 days of vaccination

crying lasting 3 hours or more within 2 days of vaccination

convulsions (seizures/fits) with or without a fever within 3 days of vaccination

you are or think you may be pregnant or if you intend to become pregnant. Your doctor will

discuss with you the possible risks and benefits of receiving BOOSTRIX-IPV during pregnancy

(in particular during the 3

trimester)

you are breast feeding. It is not known if BOOSTRIX-IPV passes into breast milk

you or your child has allergies to any other medicines or substances, such as dyes, foods or

preservatives

you or your child fainted with a previous injection. Fainting can occur following, or even before,

any needle injection.

TAKING OTHER MEDICINES

Tell your doctor or nurse if you/your child is having any prescription or OTC (over-the-counter)

medicines. In particular, mention if you/your child is being given medicines which suppress the

immune system, such as high-dose steroids.

Some vaccines may be affected by other medicines. Your doctor, nurse or pharmacist will be able

to tell you what to do if BOOSTRIX-IPV is to be given with another medicine.

HAVING OTHER VACCINES

Tell your doctor or nurse if you or your child has received another vaccine recently.

Some vaccines may be affected by other vaccines. Your doctor, nurse or pharmacist will be able

to tell you what to do if BOOSTRIX-IPV is to be given with another vaccine.

USE IN CHILDREN

BEFORE BOOSTRIX-IPV IS GIVEN TELL YOUR DOCTOR OR NURSE IF:

Your child is less than 4 years of age. The vaccine is only intended for use in children aged 4

years and above and in adults.

HOW BOOSTRIX-IPV IS GIVEN

The doctor or nurse will give BOOSTRIX-IPV as an injection. If you have any concerns about

how this vaccine is to be given, talk to your doctor, nurse or pharmacist.

HOW MUCH IS GIVEN

The dose of BOOSTRIX-IPV is 0.5mL.

HOW IT IS GIVEN

BOOSTRIX-IPV will be injected in the upper arm muscle. Each dose of BOOSTRIX-IPV is for

single use only. Any residual vaccine must be discarded.

The vaccine should never be given intravenously.

WHEN IT IS GIVEN

BOOSTRIX-IPV is generally given whenever a booster dose of diphtheria, tetanus and polio

vaccine is required and where a booster for pertussis is desired.

BOOSTRIX-IPV may also be given in the case of a tetanus-prone injury where a booster for

diphtheria, pertussis and polio is also required, provided no previous dose of tetanus vaccine was

given within five years previously.

SIDE EFFECTS

Tell your doctor or nurse as soon as possible if you or your child does not feel or look well

during or after having had a dose of BOOSTRIX-IPV vaccine.

BOOSTRIX-IPV helps protect most children and adults from diphtheria, tetanus, pertussis and

poliovirus infection, but it may have unwanted side effects in a few people. All medicines and

vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some

side effects may need medical treatment. The chance of you or your child having a serious side

effect is very much less than the chance of having a permanent injury from the natural infections.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Most unwanted effects with BOOSTRIX-IPV are mild and usually clear up within a few days. These

effects, as with other vaccines, generally occur around the injection site.

As with all injectable vaccines, severe allergic reactions (anaphylactic and anaphylactoid reactions)

may very rarely occur (with up to 1 in 10,000 doses of the vaccine). These can be recognised by:

itchy rash of the hands and feet

swelling of the eyes and face

difficulty in breathing or swallowing

sudden drop in blood pressure and loss of consciousness

These reactions will usually occur before leaving the doctor’s surgery. However, if you or your child

gets any of these symptoms you should contact a doctor urgently.

Side effects that occurred in children from 4 to 9 years of age

Very common (these may occur with more than 1 in 10 doses of the vaccine):

sleepiness

swelling, pain, redness at the injection site

Common (these may occur with up to 1 in 10 doses of the vaccine):

loss of appetite

irritability

headache

fever (more than 37.5°C)

bleeding at the injection site

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

swollen glands in the neck, armpit or groin

sleeping problems, apathy, tiredness

dry throat

vomiting, diarrhoea,

nausea, stomach pain or discomfort

Side effects that occurred in adults, teenagers and children from the age of 10 years

onwards

Very common (these may occur with more than 1 in 10 doses of the vaccine):

headache

swelling, pain, redness at the injection site

tiredness

Common (these may occur with up to 1 in 10 doses of the vaccine):

fever (more than 37.5°C)

bruising at the injection site

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

oral herpes

swollen glands in the neck, armpit or groin

decreased appetite

tingling or numbness of the hands or feet

fever (more than 39.0°C)

sleepiness

dizziness

asthma

itching

joint pain, muscle pain

chills

pain

The following side effects are not specific for any age group:

swelling of the face, mouth, tongue or throat which may cause difficulty in swallowing or

breathing

fits (with or without fever)

hives

hard lump at the injection site

extensive swelling of the vaccinated limb

unusual weakness

Other side effects not listed above, can also occur during or soon after a dose of BOOSTRIX-IPV.

Check with your doctor or nurse if you or your child has any other effects.

Do not be alarmed by this list of possible side effects. You or your child may not experience any of

them.

STORAGE

BOOSTRIX-IPV vaccine is usually stored at the doctor’s clinic or surgery, or at the pharmacy. But

if you need to store BOOSTRIX-IPV always:

Keep BOOSTRIX-IPV in the refrigerator stored between +2

C and +8

C. THE PACK SHOULD

NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.

Keep the vaccine out of the reach of children.

BOOSTRIX-IPV should be used immediately after opening.

Keep BOOSTRIX-IPV in the original pack until it is time for it to be given.

PRODUCT DESCRIPTION

WHAT IT LOOKS LIKE

BOOSTRIX-IPV comes in a prefilled syringe. It is a white, slightly milky liquid.

INGREDIENTS

The active ingredients of BOOSTRIX-IPV are non-infectious substances from tetanus, diphtheria

bacteria, purified proteins of pertussis bacteria and inactivated poliovirus. The vaccine cannot

cause these diseases. Each 0.5mL dose contains:

2 IU of diphtheria toxoid

20 IU of tetanus toxoid

8 mcg of pertussis toxoid, 8 mcg of filamentous haemagglutinin and 2.5 mcg of pertactin

40 D-antigen units of poliovirus Type 1, 8 D-antigen units of poliovirus Type 2 and 32 D-antigen

units of poliovirus Type 3

The inactive ingredients in the vaccine are: aluminium hydroxide, aluminium phosphate, sodium

chloride (salt), polysorbate 80, neomycin (traces), polymyxin (traces), formaldehyde (traces) and

water.

BOOSTRIX-IPV does not contain any infectious material.

FURTHER INFORMATION

BOOSTRIX-IPV is only available if prescribed by a doctor.

BOOSTRIX-IPV comes in a prefilled syringe in packs of 1 or 10.

DISTRIBUTOR

Distributed In New Zealand by:

GlaxoSmithKline NZ Ltd

Private Bag 106600

Downtown Auckland

Ph: (09) 367 2900

Fax (09) 367 2910

This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way.

BOOSTRIX

is a registered trade mark of the GlaxoSmithKline group of companies.

Date of Preparation: 24 May 2016, Version 3.0

NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

BOOSTRIX-IPV Combined diphtheria-tetanus-acellular pertussis (dTpa) and enhanced

inactivated polio suspension for injection

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

BOOSTRIX-IPV contains diphtheria toxoid, tetanus toxoid, and three purified pertussis

antigens

pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN/69

kiloDalton outer membrane protein)

adsorbed on aluminium salts. It also contains three

types of inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3:

Saukett strain).

1 dose (0.5 mL) contains:

Diphtheria toxoid

not less than 2 International Units (IU) (2.5 Lf)

Tetanus toxoid

not less than 20 International Units (IU) (5 Lf)

Bordetella pertussis antigens

Pertussis toxoid

8 micrograms

Filamentous Haemagglutinin

8 micrograms

Pertactin

2.5 micrograms

Inactivated poliovirus

type 1 (Mahoney strain)

40 D-antigen unit

type 2 (MEF-1 strain)

8 D-antigen unit

type 3 (Saukett strain)

32 D-antigen unit

adsorbed on aluminium hydroxide, hydrated (Al(OH)

0.3 milligrams Al

and aluminium phosphate (AlPO

0.2 milligrams Al

propagated in VERO cells

The final vaccine also contains aluminium hydroxide and aluminium phosphate as adjuvants,

sodium chloride, Medium 199, water for injections, and traces of formaldehyde, polysorbate

80, neomycin sulfate and polymyxin sulfate.

The manufacture of this product includes exposure to bovine derived materials. No

evidence exists that any case of vCJD (considered to be the human form of bovine

spongiform encephalopathy) has resulted from the administration of any vaccine product.

For the full list of excipients, see section 6.1 List of excipients.

3.

PHARMACEUTICAL FORM

Suspension for injection.

BOOSTRIX-IPV is a turbid white suspension presented in a prefilled syringe. Upon storage,

a white deposit and clear supernatant can be observed. This is a normal finding.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

BOOSTRIX-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis

and poliomyelitis of individuals from the age of four years onwards (see section 4.2 Dose

and method of administration).

BOOSTRIX-IPV is not intended for primary immunisation.

4.2

Dose and method of administration

Dose

A single 0.5 mL dose of the vaccine is recommended.

BOOSTRIX-IPV may be administered from the age of four years onwards. BOOSTRIX-IPV

should be administered in accordance with official recommendations and/or local practice

regarding the use of vaccines that provide low (adult) dose diphtheria toxoid plus tetanus

toxoid in combination with pertussis and poliomyelitis antigens.

BOOSTRIX-IPV can be used in the management of tetanus prone injuries in persons who

have previously received a primary vaccination series of tetanus toxoid vaccine. Tetanus

immunoglobulin should be administered concomitantly in accordance with official

recommendations.

Repeat vaccination against diphtheria, tetanus and poliomyelitis should be performed at

intervals as per official recommendations.

Method of administration

BOOSTRIX-IPV is for deep intramuscular injection preferably in the deltoid region.

4.3

Contraindications

BOOSTRIX-IPV should not be administered to subjects with known hypersensitivity after

previous administration of diphtheria, tetanus, pertussis or poliomyelitis vaccines or to any

component of the vaccine (see section 6.1 List of excipients).

BOOSTRIX-IPV contains traces of neomycin and polymyxin. The vaccine should not be

used in subjects with known hypersensitivity to neomycin and polymyxin.

BOOSTRIX-IPV is contraindicated if the subject has experienced an encephalopathy of

unknown aetiology, occurring within 7 days following previous vaccination with pertussis-

containing vaccine. In these circumstances, pertussis vaccination should be discontinued

and the vaccination course should be continued with diphtheria, tetanus and poliomyelitis

vaccines.

BOOSTRIX-IPV should not be administered to subjects who have experienced neurological

complications following an earlier immunisation against diphtheria and/or tetanus (for

convulsions or hypotonic-hyporesponsive episodes, see section 4.4 Special warnings and

precautions for use).

4.4

Special warnings and precautions for use

Vaccination should be preceded by a review of the medical history (especially with regard to

previous vaccination and possible occurrence of undesirable events).

As with other vaccines, administration of BOOSTRIX-IPV should be postponed in subjects

suffering from acute severe febrile illness. The presence of a minor infection is not a

contraindication.

If any of the following events are known to have occurred in temporal relation to receipt of

pertussis-containing vaccine in infancy, the decision to give doses of pertussis-containing

vaccines should be carefully considered:

Temperature of

40.0°C within 48 hours of vaccination, not due to another

identifiable cause.

Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours

of vaccination.

Persistent, inconsolable crying lasting

3 hours, occurring within 48 hours of

vaccination.

Convulsions with or without fever, occurring within 3 days of vaccination.

There may be circumstances, such as a high incidence of pertussis, when the potential

benefits outweigh possible risks.

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

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

vaccine.

In children with progressive neurological disorders, including infantile spasms, uncontrolled

epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw)

immunisation until the condition is corrected or stable. However, the decision to give

pertussis vaccine must be made on an individual basis after careful consideration of the risks

and benefits.

BOOSTRIX-IPV should be administered with caution to subjects with thrombocytopenia or a

bleeding disorder since bleeding may occur following an intramuscular administration to

these subjects. Firm pressure should be applied to the injection site (without rubbing) for at

least two minutes.

BOOSTRIX-IPV should in no circumstances be administered intravascularly.

A history or a family history of convulsions and a family history of an adverse event following

DTP vaccination do not constitute contra-indications.

Human Immunodeficiency Virus (HIV) infection is not considered as a contraindication. The

expected immunological response may not be obtained after vaccination of

immunosuppressed patients.

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.

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

4.5

Interaction with other medicines and other forms of interaction

Concomitant use with other inactivated vaccines and with immunoglobulin is unlikely to

result in interference with the immune responses.

When considered necessary, BOOSTRIX-IPV can be given concomitantly with other

vaccines or immunoglobulins.

As with other vaccines, patients receiving immunosuppressive therapy or patients with

immunodeficiency may not achieve an adequate response.

4.6

Fertility, pregnancy and lactation

Pregnancy

The use of BOOSTRIX-IPV may be considered during the third trimester of pregnancy.

For data relating to the prevention of pertussis disease in infants born to women vaccinated

during pregnancy, see section 5.1 Pharmacodynamic properties.

Safety data from a prospective observational study where BOOSTRIX (dTpa component of

BOOSTRIX-IPV) was administered to pregnant women during the third trimester (793

pregnancy outcomes) as well as data from post-marketing surveillance where pregnant

women were exposed to BOOSTRIX-IPV or to BOOSTRIX indicate no vaccine related

adverse effect on pregnancy or on the health of the foetus/newborn child.

As with other inactivated vaccines, it is not expected that the polio antigens contained in

BOOSTRIX-IPV would harm the foetus.

Human data from prospective clinical studies on the use of BOOSTRIX-IPV during the first

and second trimester of pregnancy are not available.

Limited data indicate that maternal antibodies may reduce the magnitude of the immune

response to some vaccines in infants born from mothers vaccinated with BOOSTRIX-IPV

during pregnancy. The clinical relevance of this observation is unknown.

Non-clinical data obtained with BOOSTRIX-IPV reveal no specific hazard for humans based

on conventional studies of embryo-foetal development in rats and rabbits, and also of

parturition and postnatal toxicity in rats (up to the end of the lactation period).

BOOSTRIX-IPV may be used during pregnancy when the possible advantages outweigh the

possible risks for the foetus.

Breast-feeding

The safety of BOOSTRIX-IPV when administered to breast-feeding women has not been

evaluated.

It is unknown whether BOOSTRIX-IPV is excreted in human breast milk.

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

outweigh the potential risks.

Fertility

No human data available. Non-clinical data obtained with BOOSTRIX-IPV reveal no specific

hazard for humans based on conventional studies of female fertility in rats and rabbits.

4.7

Effects on ability to drive and use machines

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

4.8

Undesirable effects

Summary of the safety profile

The safety profile presented below is based on data from clinical trials where BOOSTRIX-

IPV was administered to 908 children (from 4 to 9 years of age) and 955 adults, adolescents

and children (above 10 years of age).

The most common events occurring after vaccine administration were local injection site

reactions (pain, redness and swelling) reported by 31.3 – 82.3% of subjects overall. These

had their onset within the first day after vaccination. All resolved without sequelae.

Tabulated list of adverse reactions

Adverse reactions reported are listed according to the following frequency:

Very common ≥1/10

Common ≥1/100 and <1/10

Uncommon ≥1/1000 and <1/100

Rare ≥1/10,000 and <1/1000

Very rare <1/10,000

Children from 4 to 9 years of age

Blood and lymphatic system disorders

Uncommon: lymphadenopathy

Metabolism and nutrition disorders

Common: anorexia

Psychiatric disorders

Common: irritability

Uncommon: sleep disorder, apathy

Nervous system disorders

Very common: somnolence

Common: headache

Respiratory, thoracic and mediastinal disorders

Uncommon: dry throat

Gastrointestinal disorders

Uncommon: diarrhoea, vomiting, abdominal pain, nausea

General disorders and administration site conditions

Very common: injection site reactions (including pain, redness and swelling)

Common: fever ≥ 37.5 °C (including fever > 39°C), injection site reactions (such as

haemorrhage)

Uncommon: fatigue

Adults, adolescents and children from the age of 10 years onwards

Infections and infestations

Uncommon: oral herpes

Blood and lymphatic system disorders

Uncommon: lymphadenopathy

Metabolism and nutrition disorders

Uncommon: decreased appetite

Nervous system disorders

Very common: headache

Uncommon: paraesthesia, somnolence, dizziness

Respiratory, thoracic and mediastinal disorders

Uncommon: asthma

Gastrointestinal disorders

Common: gastrointestinal disorders

Skin and subcutaneous tissue disorders

Uncommon: pruritus

Musculoskeletal and connective tissue disorders

Uncommon: myalgia, arthralgia

General disorders and administration site conditions

Very common: injection site reactions (including pain, redness and swelling), fatigue

Common: fever ≥ 37.5 °C, injection site reactions (such as haematoma)

Uncommon: fever > 39 °C, chills, pain

The following adverse reactions were additionally reported during clinical trials with

GlaxoSmithKline’s other reduced-antigen content diphtheria-tetanus-acellular pertussis

vaccine (BOOSTRIX) where BOOSTRIX was administered to 839 children (from 4 to 9 years

of age) and 1931 adults, adolescents and children (above 10 years of age):

Children from 4 to 9 years of age

Infections and infestations

Uncommon: upper respiratory tract infection

Nervous system disorders

Uncommon: disturbances in attention

Eye disorders

Uncommon: conjunctivitis

Gastrointestinal disorders

Common: gastrointestinal disorders

Skin and subcutaneous tissue disorders

Uncommon: rash

General disorders and administration site conditions

Uncommon: injection site reactions (such as induration), pain

Adults, adolescents and children from the age of 10 years onwards

Infections and infestations

Uncommon: upper respiratory tract infection, pharyngitis

Nervous system disorders

Uncommon: syncope

Respiratory, thoracic and mediastinal disorders

Uncommon: cough

Gastrointestinal disorders

Common: nausea

Uncommon: diarrhoea, vomiting

Skin and subcutaneous tissue disorders

Uncommon: hyperhidrosis, rash

Musculoskeletal and connective tissue disorders

Uncommon: joint stiffness, musculoskeletal stiffness

General disorders and administration site conditions

Very common: malaise

Common: injection site reactions (such as injection site mass and injection site abscess

sterile)

Uncommon: influenza like illness

Subjects fully primed with 4 doses of DTPa followed by BOOSTRIX-IPV at around 4-8 years

of age show no increased reactogenicity after the second BOOSTRIX-IPV dose

administered 5 years later.

Subjects fully primed with 4 doses of DTPw followed by a BOOSTRIX-IPV around 10 years

show

increase

local

reactogenicity

after

additional

Boostrix

dose

administered 10 years later.

Post Marketing Data

Immune system disorders

Very rare: allergic reactions, including anaphylactic and anaphylactoid reactions

General disorders and administration site conditions

Rare: injection site induration

The following adverse reactions were additionally reported during post marketing

surveillance after vaccination with GlaxoSmithKline’s other reduced-antigen content

diphtheria-tetanus-acellular pertussis vaccine (BOOSTRIX):

Blood and lymphatic system disorders

Rare: angioedema

Nervous system disorders

Rare: convulsions (with or without fever)

Skin and subcutaneous tissue disorders

Rare: urticaria

General disorders and administration site conditions

Rare: extensive swelling of the vaccinated limb, asthenia

Reporting of suspected adverse reactions

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

allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions via:

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

4.9

Overdose

Cases of overdose have been reported during post-marketing surveillance. Adverse events

following overdosage, when reported, were similar to those reported with normal vaccine

administration.

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 combined, ATC code: J07CA.

Mechanism of action

Not applicable.

Clinical efficacy and safety

One month post vaccination with BOOSTRIX-IPV, immune responses in 1608 subjects were

the following:

Antigen

Response

(% vaccinees)

Adults, adolescents and

children from the age of 4

years onwards*

Diphtheria

0.1 IU/ml

83.5 – 100%

Tetanus

0.1 IU/ml

99.6 – 100%

Pertussis

Pertussis toxoid

Filamentous

haemagglutinin

Pertactin

Vaccine response

Vaccine response

Vaccine response

84.0 – 94.0%

90.1 – 97.2%

90.4 – 96.7%

Inactivated poliomyelitis

Type 1

Type 2

Type 3

Seroprotection

Seroprotection

Seroprotection

99.6 – 100%

99.6 – 100%

99.1 – 100%

*In clinical studies, seroprotection and vaccine response rates to all antigens after a booster dose of BOOSTRIX-

IPV were similar to the licensed controlled vaccines studied.

As with other adult-type Td vaccines, BOOSTRIX-IPV induces higher seroprotection rates

and higher titres of both anti-D and anti-T antibodies in children and adolescents as

compared to adults.

The pertussis antigens contained in BOOSTRIX-IPV are an integral part of the paediatric

acellular

pertussis

combination

vaccine

(INFANRIX),

which

efficacy

after

primary

vaccination has been demonstrated in the following 3-dose primary studies:

a prospective blinded household contact study performed in Germany (3, 4, 5

months schedule).

Based on data collected from secondary contacts in households where there was an index

case with typical pertussis, the protective efficacy of the vaccine was 88.7%.

an NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule).

The vaccine efficacy was found to be 84%. In a follow-up of the same cohort, efficacy

persisted

undiminished

up to

years

after completion

primary vaccination

without

administration of a booster dose against pertussis.

This study assessed duration of protection of INFANRIX given in a 3-dose schedule to

infants. A similar duration of protection cannot be assumed to apply to older children or

adults given a single dose of BOOSTRIX-IPV, regardless of previous vaccination against

pertussis.

Although

protective

efficacy

BOOSTRIX-IPV

been

demonstrated

adolescents

adult

groups,

vaccinees

these

groups

received

BOOSTRIX-IPV achieved anti-pertussis antibody titres greater than those in the German

household contact study where the protective efficacy of INFANRIX was 88.7%.

There are currently no data which demonstrate a reduction of transmission of pertussis after

immunisation with BOOSTRIX-IPV. However, it could be expected that immunisation of

immediate close contacts of newborn infants, such as parents, grandparents healthcare

workers and childcare workers would reduce exposure of pertussis to infants not yet

adequately protected through immunisation.

Effectiveness in the protection against pertussis disease in infants born to women

vaccinated during pregnancy

BOOSTRIX

BOOSTRIX-IPV

vaccine

effectiveness

(VE)

evaluated

three

observational studies, in UK, Spain and Australia. The vaccine was used during the third

trimester of pregnancy to protect infants below 3 months of age against pertussis disease,

as part of a maternal vaccination programme.

Details of each study design and results are provided below.

Study location

Vaccine

Study design

Vaccination Effectiveness (VE)

BOOSTRIX-

Retrospective,

screening method

88% (95% CI: 79, 93)

Spain

BOOSTRIX

Prospective,

matched case-

control

90.9% (95% CI: 56.6, 98.1)

Australia

BOOSTRIX

Prospective,

matched case-

control

69% (95% CI: 13, 89)

CI: confidence interval

If maternal vaccination occurs within two weeks before delivery, VE in the infant may be

lower than the figures in the table.

Persistence of immunity to diphtheria, tetanus, pertussis and polio

Five years following vaccination with BOOSTRIX-IPV, the following seroprotection /

seropositivity rates were observed in 344 children from the age of 4 onwards:

Antigen

Seroprotection/seropositivity

Children from the age

of 4 years onwards (%

vaccinees)

Diphtheria

0.1 IU/ml

89.4%

0.016 IU/ml*

98.2%

Tetanus

0.1 IU/ml

98.5%

Pertussis

Pertussis toxoid

Filamentous

haemagglutinin

Pertactin

5 EL.U/ml

40.9%

99.7%

97.1%

Poliovirus type 1

Poliovirus type 2

Poliovirus type 3

≥ 8 ED50

98.8%

99.7%

97.1%

*Percentage of subjects with antibody concentrations associated with protection against disease (

0.1 IU/ml by

ELISA assay or

0.016 IU/ml by an in-vitro Vero-cell neutralisation assay).

The following seroprotection / seropositivity rates for diphtheria, tetanus and pertussis were

observed 3 to 3.5 years, 5 to 6 years and 10 years following vaccination with BOOSTRIX

(dTpa component of BOOSTRIX-IPV) in children, adolescents and adults:

Antigen

Seroprotection/

seropositivity

Adults and adolescents from the age of 10

years onwards (% vaccinees)

3-3.5 years

persistence

5 years

persistence

10 years

persistence

Adult

Adole-

scent

Adult

Adole-

scent

Adult

Adole-

scent

Diphtheria

0.1 IU/ml*

71.2%

91.6%

84.1%

86.8%

64.6%

82.4%

0.016 IU/ml*

97.4%

100%

94.4%

99.2%

89.9%

98.6%

Tetanus

0.1 IU/ml

94.8%

100%

96.2%

100%

95.0%

97.3%

Pertussis

Pertussis

toxoid

Filamentous

haemaggluti

Pertactin

5 EL.U/ml

90.6%

100%

94.8%

81.6%

100%

99.2%

89.5%

100%

95.0%

76.8%

100%

98.1%

85.6%

99.4%

95.0%

61.3%

100%

96.0%

* Percentage of subjects with antibody concentrations associated with protection against disease (

0.1 IU/ml by

ELISA assay or

0.016 IU/ml by an in-vitro Vero-cell neutralisation assay).

BOOSTRIX-IPV administered in subjects ≥40 years of age with an incomplete, unknown or

no history of a primary series of diphtheria and tetanus toxoid vaccination history induced an

antibody response against pertussis and protected against tetanus and diphtheria in the

majority of cases.

Two subsequent doses maximised the vaccine response against diphtheria and tetanus

when administered at one and six months.

Vaccination with second dose of BOOSTRIX-IPV

The immunogenicity of BOOSTRIX-IPV, administered 5 years after a previous booster dose

of BOOSTRIX-IPV at 4 to 8 years of age, has been evaluated. One month post vaccination,

> 99 % of subjects were seropositive against pertussis and seroprotected against diphtheria,

tetanus and all three polio types.

The immunogenicity of BOOSTRIX, administered 10 years after a previous booster dose

with BOOSTRIX or reduced-antigen content diphtheria, tetanus and acellular pertussis

vaccines has been evaluated in adults. One month after the decennial BOOSTRIX dose,

>99 % of subjects were seroprotected against diphtheria and tetanus and all were

seropositive for antibodies against pertussis antigens PT, FHA and PRN.

5.2

Pharmacokinetic properties

Evaluation of pharmacokinetic properties is not required for vaccines.

5.3

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety

and toxicity.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Medium 199 (as stabilizer containing amino acids, mineral salts, vitamins and other

substances)

Sodium chloride

Water for injections.

6.2

Incompatibilities

BOOSTRIX-IPV should not be mixed with other vaccines in the same syringe.

6.3

Shelf life

The shelf life of the vaccine is 3 years.

The expiry date of the vaccine is indicated on the label and packaging.

6.4

Special precautions for storage

BOOSTRIX-IPV should be stored at +2°C to +8°C.

The vaccine should not be frozen. Discard if it has been frozen.

6.5

Nature and contents of container

BOOSTRIX-IPV is presented in a pre-filled syringe in pack sizes of 1 or 10. Syringes come

with or without needles.

The prefilled syringes are made of neutral glass type I, which conforms to European

Pharmacopoeia Requirements.

Not all pack sizes may be distributed in New Zealand.

6.6

Special precautions for disposal and other handling

Prior to vaccination, the vaccine should be well shaken in order to obtain a homogeneous

turbid white suspension and visually inspected for any foreign particulate matter and/or

variation of physical aspect prior to administration. In the event of either being observed,

discard the vaccine.

Upon removal from refrigerator, the vaccine is stable for 8 hours at + 21°C.

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

local requirements.

7.

MEDICINE SCHEDULE

Prescription Medicine

8.

SPONSOR

GlaxoSmithKline NZ Limited

Private Bag 106600

Downtown

Auckland

NEW ZEALAND

Phone:

(09) 367 2900

Facsimile:

(09) 367 2910

9.

DATE OF FIRST APPROVAL

Date of publication in the New Zealand Gazette of consent to distribute the

medicine: 18 August 2005

10.

DATE OF REVISION OF THE TEXT

14 February 2019

Summary table of changes:

Section changed

Summary of new information

Relocation of statement regarding use of Boostrix-

IPV in the third trimester

Addition of cross reference to section 5.1

Addition of data regarding protection against

pertussis disease in infants born to women

vaccinated during pregnancy

Version 8.0

Trade marks are owned by or licensed to the GSK group of companies.

© 2019 GSK group of companies or its licensor.

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