FluQuadri

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15 µg (A/Michigan/45/2015, X-275); Influenza virus A/Switzerland/8060/2017 (H3N2) like strain 15 µg (A/Brisbane/1/2018 X-311); Influenza virus B/Colorado/06/2017 - like strain 15 µg (B/Maryland/15/2016 BX-69A; Victoria lineage); Influenza virus B/Phuket/3073/2013 - like strain 15 µg (B/Phuket/3073/2013 (Yamagata lineage))
Available from:
sanofi-aventis new zealand limited
INN (International Name):
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15 µg (A/Michigan/45/2015, X-275)
Dosage:
60 mcg
Pharmaceutical form:
Suspension for injection
Composition:
Active: Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15 µg (A/Michigan/45/2015, X-275) Influenza virus A/Switzerland/8060/2017 (H3N2) like strain 15 µg (A/Brisbane/1/2018 X-311) Influenza virus B/Colorado/06/2017 - like strain 15 µg (B/Maryland/15/2016 BX-69A; Victoria lineage) Influenza virus B/Phuket/3073/2013 - like strain 15 µg (B/Phuket/3073/2013 (Yamagata lineage)) Excipient: Octoxinol 9 Phosphate Buffered Saline
Prescription type:
Prescription
Manufactured by:
Sanofi Pasteur Inc
Therapeutic indications:
FluQuadri is indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluQuadri is indicated for use in adults and children 6 months and older.
Product summary:
Package - Contents - Shelf Life: Syringe, 0.5 mL in type I USP glass cylinder with 5 needles - 5 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 0.5 mL in type I USP glass cylinder - 5 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 0.5 mL in type I USP glass cylinder - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
TT50-9365
Authorization date:
2013-08-13

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FLUQUADRI™

FluQuadri™

Inactivated Quadrivalent Influenza Vaccine, Split Virion (Influenza Virus Haemagglutinin)

Consumer Medicine Information

What is in this leaflet

Read all of this leaflet carefully

before you are vaccinated.

Keep this leaflet. You may need

to read it again.

If you have any further questions,

ask your doctor or pharmacist.

This vaccine has been prescribed

for you. Do not pass it on to

others.

If any of the side effects gets

serious, or if you notice any side

effects not listed in this leaflet,

please tell your doctor or

pharmacist.

In this leaflet:

What FluQuadri is and what it is

used for

Before you are given FluQuadri

How FluQuadri is given

Possible side effects

Storing FluQuadri

Further information

What FluQuadri is and

what it is used for

FluQuadri is a vaccine. Vaccines are

used to protect you against infectious

diseases.

FluQuadri is recommended to help

protect you against influenza.

FluQuadri may be administered to

persons aged 6 months and older,

especially who run an increased risk

of influenza-associated

complications.

Influenza (flu) is a disease caused by

different types of virus. Influenza

viruses can spread rapidly, especially

in homes or institutions, where it can

be very easy for someone to catch flu

and spread the disease. The greatest

risk of catching flu is during the cold

months between May and October.

Your doctor will be able to

recommend the best time for you to

be vaccinated. Flu is present every

year, even when epidemics or

outbreaks are not reported.

The vaccine will only help to prevent

flu if it is caused by one of the four

strains of virus contained in the

vaccine, or other strains closely

related to them. FluQuadri not

prevent flu if you are incubating the

disease before vaccination or if it is

caused by another virus.

You should also note that many

germs can cause influenza-like

illness and the vaccine will not

protect you against these.

Previous injections of flu vaccine are

unlikely to give you protection

against the current strains of flu virus

which are most common this year, so

you will need to receive a vaccine

against flu every year especially if

you are at risk.

How It Works

FluQuadri works by helping the body

to make antibodies. These antibodies

help the body to recognise the flu

virus and prevent the infection. It

takes a few weeks for the body to

produce these antibodies. The

vaccine will protect you only against

the influenza viruses contained in the

vaccine (or other strains closely

related to them). It will not protect

you from viruses that are unrelated to

those contained in the vaccine.

Before you are given

FluQuadri

When you or your child

must not be given it

Do not have FluQuadri

If you or your child ever had a severe

allergic reaction to:

Any ingredients of FluQuadri

listed in the FURTHER

INFORMATION section.

If you or your child ever had a

severe allergic reaction after

getting any flu vaccine.

Before speaking to your doctor, if

you or your child has an acute

illness with or without high

temperature.

Take special care with

FluQuadri

Tell your doctor if you or your

child has or has had Guillain-

Barré syndrome (severe muscle

weakness) after getting a flu

vaccine

Tell your doctor if you or your

child has or has had an immune

response problem because the

immune response to the vaccine

may be diminished

Tell your doctor if you are

pregnant or breast feeding.

Tell your doctor if you or your

child are allergic to egg or egg

products

Your doctor will discuss the possible

risks and benefits of having

FluQuadri during pregnancy or

breastfeeding. Due to the known

FLUQUADRI™

adverse consequences of influenza

infection in pregnant women, health

authorities recommend vaccination

for pregnant women.

Your doctor should make sure the

benefits of vaccination outweigh the

risks when recommending

FluQuadri.

Taking other medicines

Medicines that may reduce your

immune response: such as

corticosteroids (for example

prednisone), medicines used to

treat cancer (chemotherapy),

radiotherapy or other medicines

affecting the immune system. Tell

your doctor if you have been

treated with such medicines.

Please tell your doctor or

pharmacist if you are taking or

have recently taken any other

medicines, including medicines

obtained without prescription.

Having other vaccines

Your doctor will advise you if

FluQuadri is to be given with

another vaccine.

How FluQuadri is

given

FluQuadri is administered to you by

your doctor, nurse or pharmacist.

Dose and Schedule

Adults and children 6 months and

older: A single 0.5 mL injection

Some children require a second

injection a month later.

Method of Administration

FluQuadri is injected into the

muscles of the upper arm

(preferably). For infants, the injection

is normally given into the muscle of

the thigh.

Possible side effects

Like all medicines, FluQuadri can

cause side effects, although not

everybody gets them.

The most common local side effects

of FluQuadri include:

pain, tenderness, redness

(erythema), swelling, bruising

(ecchymosis) and hardness

(induration) at the injection site

Systemic side effects include:

feeling unwell (malaise)

muscle aches (myalgia)

headache

shivering

fever

irritability, abnormal crying,

drowsiness, appetite loss,

vomiting (in children)

These side effects usually clear up

within a few days. If events

continue or become severe, please

tell your doctor or pharmacist.

Other side effects not listed above

have been reported occasionally with

other flu vaccines and not directly

with FluQuadri:

inflammation of nerves leading to

weakness, such as weakness of

facial muscles (facial palsy) or

visual disturbances (optic

neuritis/neuropathy)

fainting (syncope), dizziness,

tingling or numbness of hands or

feet (paraesthesia)

temporary inflammation of nerves

causing pain, paralysis and

sensitivity disorders (Guillain-

Barré syndrome [GBS])

fits (convulsions) with or without

fever

severe allergic reaction

(anaphylaxis)

temporary reduction in the

number of blood particles called

platelets (thrombocytopenia),

swollen glands in neck, armpit or

groin (lymphadenopathy)

If any of the side effects gets

serious, or if you notice any side

effects not listed in this leaflet,

please tell your doctor or

pharmacist.

Storing FluQuadri

FluQuadri is usually stored in the

doctor’s surgery or clinic, or at the

pharmacy. However, if you need to

store FluQuadri:

Keep out of reach and sight of

children.

Keep FluQuadri in the original

pack until it is time for it to be

given.

Keep it in the refrigerator,

store at 2C to 8C. Do not freeze

FluQuadri.

Do not use FluQuadri after the

expiry date which is stated on the

carton after EXP.

Do not have FluQuadri the

packaging is torn or shows signs of

tampering.

Medicines should not be disposed of

via wastewater or household waste.

Ask your pharmacist how to dispose

of medicines no longer required.

These measures will help to protect

the environment.

Further Information

What FluQuadri contains

Ingredients

Active Ingredients:

FluQuadri contains 4 killed influenza

virus strains:

A/Michigan/45/2015

(H1N1)pdm09-like virus

(A/Michigan/45/2015 X-275)

A/Switzerland/8060/2017

(H3N2)- like virus

(A/Brisbane/1/2018 X-311)

B/Phuket/3073/2013-like virus

(B/Phuket/3073/2013)

FLUQUADRI™

B/Colorado/06/2017-like virus

(B/Maryland/15/2016 BX-69A)

The other ingredients include sodium

chloride, dibasic sodium phosphate,

monobasic sodium phosphate,

octoxinol-9, water for injection, and

traces of formaldehyde.

Other Ingredients:

FluQuadri contains less than 1

microgram ovalbumin (egg protein)

per dose.

FluQuadri does not contain any

antibiotics or preservative.

What FluQuadri looks like

and contents of the pack

FluQuadri is supplied in:

Prefilled syringe (clear syringe

plunger rod), 0.5 mL, with or

without separate needles, for

persons 3 years and older.

Name and Address of

Australian Sponsor

sanofi-aventis australia pty ltd

Talavera Corporate Centre - Building

12-24 Talavera Road

Macquarie Park NSW 2113

Australia

Tel: 1800 818 806

Name and Address of New

Zealand Sponsor

sanofi-aventis new zealand limited

56 Cawley St

Ellerslie

Auckland

New Zealand

Tel: 0800 283 684

AUST R number

AUST R 213963 (FluQuadri)

Date of preparation

29 July 2021

fluq-ccdsv2-cmiv5-29jul21

Read the complete document

fluquadri-ccdsv2-dsv5-29jul21

NEW ZEALAND DATA SHEET – FLUQUADRI INFLUENZA VIRUS

HAEMAGGLUTININ

1

NAME OF THE MEDICINE

FluQuadri™

Inactivated Quadrivalent Influenza Vaccine, Split Virion (Influenza Virus Haemagglutinin)

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

FluQuadri for intramuscular injection is an inactivated influenza virus vaccine, prepared from

influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid

is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in

a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then

chemically disrupted using a non-ionic surfactant, octoxinol-9 (Triton

X-100), producing a

“split virus”. The split virus is further purified and then suspended in sodium phosphate-

buffered isotonic sodium chloride solution. Antigens from the four strains included in the

vaccine are produced separately and then combined to make the quadrivalent formulation.

It is formulated to contain the following four influenza strains recommended for the 2019

influenza season:

Active Substance

Quantity

(per 0.5mL dose)

A/Michigan/45/2015 (H1N1) pdm09-like virus (A/Michigan/45/2015 X-275)

15 micrograms HA**

A/Switzerland/8060/2017 (H3N2)- like virus (A/Brisbane/1/2018 X-311

15 micrograms HA**

B/Phuket/3073/2013-like virus (B/Phuket/3073/2013; Yamagata lineage)

15 micrograms HA**

B/Colorado/06/2017-like virus (B/Maryland/15/2016 BX-69A; Victoria lineage)

15 micrograms HA**

** haemagglutinin

FluQuadri contains 60 micrograms (µg) haemagglutinin (HA) per 0.5 mL dose in the

recommended ratio of 15 µg HA of each of the four strains.

The type and amount of viral antigens contained in FluQuadri conform to the annual

requirements of the Australian Influenza Vaccine Committee (AIVC) and the World Health

Organization (WHO) recommendations for the season.

Neither antibiotics nor preservative are used during manufacture.

FluQuadri is presented in prefilled syringes that are not made with natural rubber latex.

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

fluquadri-ccdsv2-dsv5-29jul21

3

PHARMACEUTICAL FORM

Sterile aqueous suspension for injection.

FluQuadri suspension for injection is clear and slightly opalescent in colour.

4

CLINICAL PARTICULARS

4.1

THERAPEUTIC INDICATIONS

FluQuadri is indicated for active immunisation of influenza disease caused by influenza A

subtype viruses and type B viruses contained in the vaccine.

FluQuadri is indicated for use in adults and children 6 months and older.

4.2

DOSE AND METHOD OF ADMINISTRATION

FluQuadri should be given in accordance with the national recommendation as per the current

Immunisation Handbook.

Administration should be carried out by the intramuscular route. The dose and schedule are as

follows:

Children and adults 6 months of age and older: 0.5 mL dose

For children under 9 years of age who have not been adequately primed based on influenza

vaccination history, a second dose should be administered approximately 4 weeks apart.

Inspect FluQuadri visually for particulate matter and/or discolouration prior to administration.

If any of these defects or conditions exist, the vaccine should not be administered.

Before administering a dose of vaccine, shake the prefilled syringe.

The syringe is for single use only and must not be reused. Discard any remaining unused

contents.

needle

size

length,

refer

national

recommendations

current

Immunisation Handbook.

FluQuadri should not be mixed with any other vaccine in the same syringe or vial.

The preferred site of administration is into the deltoid muscle in adults and children ≥ 12

months of age. The preferred site for infants and young children (6 months to < 12 months of

age) is the anterolateral aspect of the thigh. The vaccine should be administered into healthy

well developed muscle and should not be injected into the gluteal region where there may be a

risk of local neural, vascular and tissue injury.

fluquadri-ccdsv2-dsv5-29jul21

4.3

CONTRAINDICATIONS

FluQuadri should not be administered to anyone with a known systemic hypersensitivity

reaction, such as anaphylaxis, after previous administration of any influenza vaccine or to any

component of the vaccine (see Section 2 Qualitative and Quantitative Composition and

Section Section Section 6.1 List of Excipients).

Vaccination should be postponed in case of moderate or severe acute or febrile disease with or

without fever but a mild disease with low-grade fever is usually not a reason to postpone

vaccination.

4.4

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Do not administer intravenously.

Hypersensitivity

Prior

vaccine

injection,

known

precautions

should

taken

prevent

hypersensitivity reactions. This includes a review of the individual’s prior vaccination history

with respect to possible hypersensitivity to the vaccine or similar vaccines.

As each dose may contain traces of formaldehyde and octoxinol-9 which are used during

vaccine

production,

caution

should

exercised

when

vaccine

administered

individuals with hypersensitivity to either one of these products.

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

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

especially for individuals who have a known allergy to egg protein.

Neurological Disorders

Patients with a history of Guillain-Barré Syndrome (GBS) with an onset related in time to

influenza vaccination may be at increased risk of again developing GBS, but whether

vaccination specifically might increase the risk for recurrence is unknown. Because patients

with a history of GBS have an increased likelihood of again developing the syndrome, the

chance of them coincidentally developing the syndrome following influenza vaccination may

be higher than in individuals with no history of GBS. If GBS has occurred within 6 weeks

following previous influenza vaccination, the decision to give FluQuadri should be based on

careful consideration of the potential benefits and risks. Refer to the current Immunisation

Handbook for further details.

Immunosuppressive Treatments or Conditions

The immunogenicity of FluQuadri may be reduced by immunosuppressive treatment or in

individuals with immune deficiency syndromes. Vaccination of individuals with chronic

immunodeficiencies is recommended even though the antibody response may be limited.

fluquadri-ccdsv2-dsv5-29jul21

Protection

Influenza virus is remarkably unpredictable in that significant antigenic changes may occur

from time to time. It is known that influenza vaccines, as now constituted, are not effective

against all possible strains of influenza virus. Protection is limited to those strains of virus from

which the vaccine is prepared or to closely related strains.

As with any vaccine, vaccination with FluQuadri may not protect 100% of susceptible

individuals.

Bleeding disorder

Because any intramuscular injection can cause an injection-site haematoma in individuals with

any bleeding disorder, such as haemophilia or thrombocytopenia, or in individuals on

anticoagulant therapy, intramuscular injections with FluQuadri should not be administered to

such individuals unless the potential benefits outweigh the risk of administration. If the

decision is made to administer any product by intramuscular injection to such individuals, it

should be given with caution, with steps taken to avoid the risk of haematoma formation

following injection.

Syncope

Syncope (fainting) has been reported following vaccination with FluQuadri. Procedures should

be in place to prevent falling injury and manage syncopal reactions.

Use in the elderly

Safety and immunogenicity of FluQuadri were evaluated in adults 65 years of age and older

(See

Section

Pharmacodynamic

Properties,

Clinical

Trials).

Antibody

responses

FluQuadri are lower in individuals ≥ 65 years of age than in younger adults.

Paediatric use

Safety and effectiveness of FluQuadri in children below the age of 6 months have not been

established. Children in Study GRC88 aged between 6 and < 12 months were required to be

born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 2.5 kg.

Preterm infants (< 37 weeks gestation) are strongly recommended to receive influenza vaccine

each year, starting at ≥ 6 months of age. Refer to the current Immunisation Handbook.

Effects on laboratory tests

Interference of FluQuadri with laboratory and/or diagnostic tests has not been studied.

Following influenza vaccination, false positive results in serology tests using the ELISA

method to detect antibodies against HIV1, hepatitis C, and especially HTLV1 have been

observed. An appropriate Western Blot test should be used to confirm or disprove the results

of the ELISA test. The transient false-positive reactions could be due to a non-specific IgM

response induced by the vaccine.

fluquadri-ccdsv2-dsv5-29jul21

4.5

INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF

INTERACTIONS

FluQuadri should not be mixed with any other vaccine in the same syringe or vial.

Data evaluating the concomitant administration of FluQuadri with other vaccines are not

available.

If FluQuadri is to be given at the same time as another injectable vaccine(s), the vaccine(s)

should always be administered at different injection sites. Refer to the current Immunisation

Handbook for further details.

Although inhibition of hepatic clearance of phenytoin, theophylline and warfarin has been

reported after influenza vaccination, subsequent studies have not shown any evidence of

undesirable effects related to this phenomenon.

vaccine

used

individuals

deficient

producing

antibodies

immunosuppressive therapy, the expected immune response may not be obtained.

4.6

FERTILITY, PREGNANCY AND LACTATION

Effects on fertility

FluQuadri has not been evaluated for the possible effects on human fertility. A reproductive

toxicity study in which female rabbits were administered FluQuadri 24 and 10 days before

insemination showed no effects on female fertility (see Use in Pregnancy).

Use in pregnancy (Category A)

A developmental and reproductive toxicity study has been performed in female rabbits at a

dose approximately 20 times the human dose (on a mg/kg basis) and has revealed no evidence

of impaired female fertility or harm to the foetus due to FluQuadri.

In the developmental and reproductive toxicity study, female rabbits were administered

FluQuadri or control saline (each 0.5 mL/dose) by intramuscular injection 24 and 10 days

before insemination, and on Days 6, 12, and 27 of gestation. The administration of FluQuadri

did not result in systemic maternal toxicity (no adverse clinical signs and no change in body

weight or food consumption). In addition, no adverse effects on pregnancy, parturition,

lactation, or embryo-foetal or pre-weaning development were observed. There were no

vaccine-related foetal malformations or other evidence of teratogenesis noted in this study.

Data from studies involving large numbers of women (> 80,000) vaccinated during pregnancy

with inactivated influenza vaccines do not indicate any adverse foetal and maternal outcomes

attributable to the vaccine. FluQuadri should be given to a pregnant woman following an

assessment of the risks and benefits. Because of the known adverse consequences of influenza

infection in pregnant women, health authorities recommend vaccination of pregnant women.

fluquadri-ccdsv2-dsv5-29jul21

Use in lactation

It is not known whether FluQuadri is excreted in human milk hence, caution should be used

when administering vaccine to breastfeeding women.

4.7

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

No studies on the effects on the ability to drive or use machines have been performed.

4.8

ADVERSE EFFECTS (UNDESIRABLE EFFECTS)

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates

observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical

trial of another vaccine, and may not reflect the rates observed in practice.

The safety of FluQuadri was evaluated in 3,307 trial participants in 3 clinical trials in the United

States (1,223 children 6 to 35 months of age, 1,669 children 3 to 8 years of age, 190 adults ≥18

years of age, and 225 adults ≥65 years of age). For children requiring a second dose, the doses

were administered approximately 4 weeks apart. The most common injection-site reaction in

children and adults was pain. The most frequent systemic reaction in infants and toddlers (6 to

35 months receiving 0.25 mL) was irritability, while myalgia was the most frequent systemic

reaction reported in children (3 to 8 years) and adults.

In children, the most commonly reported unsolicited non-serious adverse events were cough,

vomiting, and pyrexia. In adults, oropharyngeal pain, rhinorrhoea, injection-site induration, and

headache were the most commonly reported unsolicited adverse events.

Across the 3 trials, one serious adverse event was thought to be caused by vaccination with

FluQuadri: a 13-month-old who experienced croup 3 days post-first vaccination; the participant

recovered within 18 days without sequelae and continued in the trial. In clinical trial QIV04

other serious adverse events considered to be possibly related to vaccination were; in the US-

licensed comparator 2010-2011 TIV group a 4-year-old who experienced a febrile convulsion

one day post-first vaccination, and in the unlicensed investigational TIV group an 11-month-

old who experienced a febrile convulsion on the day of second vaccination.

The frequency of the solicited injection-site and systemic reactions reported in the trials are

shown in Table 1 and Table 2.

fluquadri-ccdsv2-dsv5-29jul21

Table 1 - Percentage of Solicited Injection-Site Reactions and Systemic Adverse Events in

Children After Vaccination with FluQuadri (Safety Analysis Set)

a

Children 6 to 35 months of age

(0.25 mL)

Children 3 to 8 years of age

(0.5 mL)

FluQuadri

N

=1223

TIV-1

c

B (Victoria)

N

=310

TIV-2

d

B (Yamagata)

N

=308

FluQuadri

N

=1669

TIV-1

c

B (Victoria)

N

=424

TIV-2

d

B (Yamagata)

N

=413

Injection site reactions

Pain

57.0

52.3

50.3

66.6

64.6

63.8

Tenderness

54.1

48.4

49.7

Erythema

37.3

32.9

33.3

34.1

36.8

35.2

Swelling

21.6

19.7

17.3

24.8

25.4

25.9

Systemic reactions

Myalgia

26.7

26.6

e

25.0

e

38.6

34.1

38.4

Headache

e

12.2

e

23.1

21.2

24.4

Malaise

38.1

35.2

e

32.4

e

31.9

32.8

33.4

Irritability

54.0

52.8

53.5

Crying-

abnormal

41.2

36.5

29.9

Drowsiness

37.7

32.1

31.9

Appetite loss

32.3

33.3

25.0

Vomiting

14.8

11.3

13.9

Fever

14.3

16.0

13.0

a

The safety analysis set includes all persons who received study vaccine

b

N is the number of subjects in the safety analysis set

2010-2011 Fluzone TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria

lineage), licensed in the United States

Investigational TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/04/2006 (Yamagata lineage),

non-licensed

e

Assessed in children 24 months to 35 months of age

f

Assessed in children 6 months to 23 months of age

Table 2 - Percentage of Solicited Injection-Site Reactions and Systemic Adverse Events in

Adults After Vaccination with FluQuadri (Safety Analysis Set)

a

Adults 18 years of age and older

Adults 65 years of age and older

FluQuadri

N

=190

TIV-1

c

B (Victoria)

N

=190

TIV-2

d

B (Yamagata)

N

=190

FluQuadri

N

=225

TIV-1

e

B (Victoria)

N

=225

TIV-2

f

B (Yamagata)

N

=225

Injection site reactions

Pain

47.4

52.1

43.2

32.6

28.6

23.1

Erythema

fluquadri-ccdsv2-dsv5-29jul21

Adults 18 years of age and older

Adults 65 years of age and older

Swelling

Induration

Ecchymosis

Systemic reactions

Myalgia

23.7

25.3

16.8

18.3

18.3

14.2

Headache

15.8

18.4

18.0

13.4

11.6

11.6

Malaise

10.5

14.7

12.1

10.7

11.6

Shivering

Fever

a

The safety analysis set includes all persons who received study vaccine

b

N is the number of subjects in the safety analysis set

2009-2010 Fluzone TIV containing A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2), and B/Brisbane/60/2008 (Victoria

lineage), licensed in the United States

2008-2009 Fluzone TIV containing A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2), and B/Florida/04/2006 (Yamagata

lineage), licensed in the United States

2010-2011 Fluzone TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria

lineage), licensed in the United States

Investigational TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/04/2006 (Yamagata lineage),

non-licensed

A 0.5-mL Dose of FluQuadri in Children 6 Months through 35 Months of Age

GRC88 was an observer-blind multi-centre study conducted in the US, including healthy

children age between 6 and 35 months. Infants less than 12 months of age were of gestational

age ≥ 37 weeks and/or birth weight ≥ 2.5 kg. Participants were randomly assigned to receive

a FluQuadri dose of 0.25 mL (Group 1) or 0.5 mL (Group 2). For children requiring a second

dose, the same dose was administered 4 weeks after the first. Participants who received at

least one dose of study vaccine were included in the safety analysis set: Group 1 n = 949;

Group 2 n = 992.

The primary objective was to assess difference in fever rate ≥ 38°C (Group 2 minus Group

1). The difference, 0.84% (95% CI: -2.13%; 3.80%), met the prespecified non-inferiority

criterion (upper limit of the 2-sided 95% CI of the difference in fever rates < 5%).

The frequencies of solicited injection-site reactions occurring within 7 days after vaccination

(Group 1 vs. Group 2) were: tenderness (47% vs. 50%), erythema (23% vs. 24%), and

swelling (13% vs. 15%).

The frequency of systemic adverse reactions occurring within 7 days after vaccination (Group

1 vs. Group 2) were:

irritability (47% vs. 49%), abnormal crying (33% vs. 34%), drowsiness

(32% vs. 31%), appetite loss (27% vs. 28%), fever of ≥ 38°C (11% vs. 12%), and vomiting

(10% vs. 10%).

The frequency of solicited

systemic reactions tended to be higher in the subgroup aged 6 to <

24 months than the subgroup aged 24 to > 36 months. Group 1 (n = 533) vs. Group 2 (n =

561): fever 12% vs. 16%, vomiting 12% vs. 14%, abnormal crying 38% vs. 39%, drowsiness

34% vs. 35%, loss of appetite 27% vs. 31% and irritability 49% vs. 54%.

fluquadri-ccdsv2-dsv5-29jul21

Participants were monitored for unsolicited adverse events for the 28 days following

vaccination. Non-serious adverse events were reported in 44% of Group 1 and 40% of Group

2, the most commonly reported in both groups being cough and rhinorrhoea. Five serious

adverse events were reported in each group, one event of chronic urticaria occurring in Group

1 was considered vaccine related and an event of special interest. There were no deaths

reported during the trial period.

Adverse Reactions from Post-Marketing Surveillance

Currently, there are limited post-marketing data available for FluQuadri.

The following events have been spontaneously reported during the post-approval use of

Fluzone (TIV)1. Because these events are reported voluntarily from a population of uncertain

size, it is not always possible to reliably estimate their frequency or establish a causal

relationship to vaccine exposure. Adverse events were included based on one or more of the

following factors: severity, frequency of reporting, or strength of evidence for a causal

relationship to Fluzone.

Blood and Lymphatic System Disorders

: Thrombocytopenia, lymphadenopathy

Immune

System

Disorders

Anaphylaxis,

other

allergic/hypersensitivity

reactions

(including urticaria, angioedema)

Eye disorders

: Ocular hyperemia

Nervous

System

Disorders

Guillain-Barré

syndrome

(GBS),

convulsions,

febrile

convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy

(Bell’s

palsy),

optic

neuritis/neuropathy,

brachial

neuritis,

syncope

(shortly

after

vaccination), dizziness, paresthesia

Vascular Disorders

Vasculitis, vasodilation/flushing

Respiratory, Thoracic and Mediastinal Disorder

s: Dyspnea, pharyngitis, rhinitis, cough,

wheezing, throat tightness

Skin and Subcutaneous Tissue Disorders

: Stevens-Johnson syndrome

General Disorders and Administration Site Conditions

Pruritus, asthenia/fatigue, pain in

extremities, chest pain

Gastrointestinal Disorders

Vomiting

Reporting suspected adverse effects

Reporting suspected adverse reactions after registration of the medicinal product is important.

It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-

problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

Fluzone is the US-licensed TIV upon which manufacture of FluQuadri is based.

fluquadri-ccdsv2-dsv5-29jul21

4.9

OVERDOSE

For information on the management of overdose, contact the Poisons Information Centre, on

13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New

Zealand).

5

PHARMACOLOGICAL PROPERTIES

5.1

PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB

Mechanism of action

FluQuadri provides active immunisation against the four influenza virus strains (two A

subtypes and two B strains) contained in the vaccine. FluQuadri induces humoral antibodies

against the haemagglutinins. Specific levels of haemagglutination-inhibition (HI) antibody titre

post-vaccination with inactivated influenza virus vaccines have not been correlated with

protection from influenza illness, but HI antibody titres have been used as a measure of vaccine

activity. In some human challenge studies, HI antibody titres of ≥ 1:40 have been associated

with protection from influenza illness in up to 50% of participants. HI antibody titres ≥ 1:40

are generally obtained within 3 to 4 weeks. Annual influenza vaccination is recommended as

immunity declines during the year after vaccination and because circulating strains of influenza

virus may change from year to year.

Clinical trials

Immunogenicity of FluQuadri in Children 6 Months to 8 Years of Age

QIV04 (NCT01240746, see http://clinicaltrials.gov) was a phase III, randomised, observer-

blinded, active-controlled, 3-arm, multi-centre trial of children aged 6 months to 8 years

stratified into 2 age groups: 6 to 35 months of age and 3 to 8 years of age. The trial was

conducted in the United States during November 2010 – January 2012.

The aim was to compare the immunogenicity and safety of FluQuadri containing A/California

A/Victoria, B/Brisbane (Victoria lineage), and B/Florida (Yamagata lineage) with the 2010-

2011 seasonal trivalent inactivated influenza vaccine (TIV) containing B/Brisbane, and an

investigational TIV containing B/Florida. Each TIV contained the same A strains as FluQuadri.

The manufacturing process was the same for each vaccine and was based on the production

process for the US-licensed TIV (Fluzone

Participants were randomised to receive one of three vaccines (FluQuadri, 2010-2011 TIV, or

investigational TIV). Children 6 to 35 months of age were administered 0.25 mL of assigned

vaccine containing 7.5 µg of HA per strain. Children 3 to 8 years were administered 0.5 mL of

assigned vaccine containing 15 µg of HA per strain. As per recommendations of the United

States

Advisory

Committee

Immunization

Practices,

children

were

considered

adequately primed based on influenza vaccination history received one dose; all other children

received two doses with a four-week interval between vaccinations.

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