Consumer medicine information

Afluria Quad

Influenza virus vaccine, split virion, quadrivalent (inactivated)

BRAND INFORMATION

Brand name

Afluria Quad

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Afluria Quad.

What is in this leaflet

This leaflet answers some common questions about Afluria® Quad 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, including vaccines, have risks and benefits. Your doctor considers the risks of you or your child having Afluria® Quad vaccine and the benefits they expect it will have.

If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.

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

What Afluria® Quad vaccine is used for

Afluria® Quad vaccine helps prevent influenza, often called “the flu”. Influenza is caused by infection with specific influenza viruses. New types of influenza viruses can appear each year. Afluria® Quad vaccine contains fragments of four different types of influenza virus. Each year the Australian Influenza Vaccine Committee decides which four types of viruses are most suitable to include in the vaccine.

The virus in the vaccine has been killed. Therefore the vaccine cannot give you or your child “the flu”.

Note: the vaccine will not protect you or your child from the other influenza viruses that Afluria® Quad vaccine does not contain.

Afluria® Quad vaccine is a prescription only medicine. This year (2020) the viruses are A/Brisbane/02/2018 (H1N1)pdm09 – like virus, A/South Australia/34/2019 (H3N2) – like virus, B/Washington/02/2019 and B/Phuket/3073/2013 – like virus.

Vaccination against influenza is recommended every year, for anyone wanting to lower their chance of catching influenza.

How Afluria® Quad vaccine works

Afluria® Quad vaccine works by causing your body to protect itself against infection by the influenza viruses, types A and B, that are in the vaccine. The vaccine stimulates the body to make substances, called antibodies. Antibodies fight the influenza virus. If you have been vaccinated, when you come into contact with the influenza viruses in the vaccine, your body is usually able quickly to destroy the virus. This prevents you from getting influenza.

Your body takes a few weeks after vaccination to fully develop protection against the influenza virus.

Protection against influenza generally requires one dose of Afluria® Quad vaccine. Some people including children who have not received influenza vaccination before may require two doses.

Most people make satisfactory antibodies against the influenza virus. However, as with all vaccines, 100% protection cannot be guaranteed.

The chance of having a severe unwanted reaction after having Afluria® Quad vaccine is very small. Whereas, the risks of not being vaccinated against influenza may be very serious.

Before you or your child are given Afluria® Quad vaccine

When you or your child must not be given Afluria® Quad vaccine

Your child must not be given Afluria® Quad vaccine if they are under 5 years old. For the 2020 influenza season, Afluria® Quad vaccine is only for use in children aged 5 years and over.

Do not have Afluria® Quad vaccine if you or your child has previously had a severe allergic reaction to:

  • any influenza vaccine
  • any of the ingredients listed at the end of this leaflet.

Symptoms of a severe allergic reaction may include:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body.

Do not have Afluria® Quad vaccine if you or your child have/has a temperature higher than 38.5ºC.

Do not have Afluria® Quad vaccine after the expiry date printed on the packaging.

If you are not sure whether you or your child should have Afluria® Quad vaccine, talk to your doctor, nurse or pharmacist.

Before you or your child are given Afluria® Quad vaccine

Tell your doctor if in the past you or your child have/has reacted to vaccination with any of the following:

  • severe allergic reaction
  • difficulty breathing
  • swelling of the throat
  • fainting or collapse
  • fits or convulsions
  • high temperature (greater than 38.5°C)
  • severe skin reaction at the injection site, including severe bruising.

Tell your doctor if you or your child have/has an infection or temperature higher than 38.5°C. Your doctor may decide to delay vaccination until the illness has passed. A minor illness such as a cold is not usually a reason to delay vaccination.

Tell your doctor if in the past you or your child have/has had any medical conditions, especially the following:

  • low immunity due to ill-health, for example some blood disorders, malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
  • low immunity due to treatment with medicines such as corticosteroids, cyclosporin or other medicines, used to treat cancer (including radiation therapy)
  • allergies or allergic reactions, including: runny, blocked or itchy nose; itchy rash or hives; swelling of the face, lips, mouth or tongue
  • Guillain-Barré Syndrome (GBS), an illness which affects the nervous system and causes paralysis.

Tell your doctor if you or your child have allergies to:

  • any other medicines
  • any other substances, such as latex, foods, preservatives or dyes.

Tell your doctor if you are pregnant, or are planning to become pregnant. Your doctor will discuss the potential risks and benefits of having Afluria® Quad vaccine during pregnancy and advise on the timing of Afluria® Quad vaccination with regards to pregnancy.

Tell your doctor if you are breast-feeding. Your doctor will discuss the potential risks and benefits of having Afluria® Quad vaccine while you are breast-feeding.

Taking other medicines

Tell your doctor, nurse or pharmacist if you or your child are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Afluria® Quad vaccine may interfere with each other.

The following medicines or treatments may affect how well Afluria® Quad vaccine works:

  • medicines which affect the body’s immune response, such as corticosteroids, cyclosporin or
  • some treatments for cancer (including radiation therapy).

Your doctor, nurse or pharmacist will help you decide whether or not you or your child should have the vaccine.

Having other vaccines

Tell your doctor if you or your child have had any vaccines in the last 4 weeks.

Afluria® Quad vaccine can be given at the same time as other vaccines.

Your doctor will tell you if Afluria® Quad vaccine is to be given at the same time as another vaccine.

How Afluria® Quad vaccine is given

How it is given

Afluria® Quad vaccine is given by a doctor, nurse or pharmacist, as an injection into the muscle or under the skin of your upper arm.

Afluria® Quad vaccine should be given at facilities able to manage any allergic reaction. Allergy to Afluria® Quad vaccine is uncommon, but allergy to any vaccine may occur.

How much is given

Afluria® Quad vaccine is given once every year, as follows:

  • Adults and children 5 years and over: one injection of 0.5 mL

For children 5 to under 9 years old who are receiving influenza vaccine for the first time, it is recommended that a follow-up (booster) dose of Afluria® Quad vaccine is given 4 weeks after the first dose.

If the follow-up dose is missed, talk to your doctor and arrange another visit as soon as possible.

Overdose is unlikely as your doctor or nurse gives you or your child the injection and it is pre-packed in individual single-use syringes.

If you have any concerns, ask your doctor, nurse or pharmacist.

When it is given

Afluria® Quad vaccine is usually given before the start of the influenza season.

Vaccination should be repeated every year as new types of influenza virus can appear each year.

After having Afluria® Quad vaccine

Things you or your child must do

Keep an updated record of you and your child's vaccinations.

Keep any follow-up appointments with your doctor or clinic.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you or your child feel unwell after having the vaccine.

Afluria® Quad vaccine may have unwanted side effects in a few people. All medicines, including vaccines, can have side effects. Sometimes they are serious, most of the time they are not. You or your child may need medical treatment for some of the side effects.

The 2010 formulation of Fluvax® trivalent (three strain) influenza vaccine (manufactured by Seqirus Pty Ltd) was associated with increased reports of febrile convulsions in children younger than 5 years.

Your child must not be given Afluria® Quad vaccine if they are under 5 years old as safety in this age group has not been established.

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

The following are the more common side effects of Afluria® Quad vaccine. Mostly these are mild and short-lived.

Tell your doctor, nurse or pharmacist if you or your child notice any of the following and they worry you:

  • reaction around the injection site such as tenderness, bruising, redness, warmth, pain, swelling or the formation of hard lumps
  • flu-like symptoms, such as headache, tiredness, fever, sore throat, runny nose, blocked nose, sneezing, cough, chills
  • vomiting, nausea, diarrhoea
  • aching muscles.

The following may be serious side effects and you or your child may need urgent medical attention. However, these side effects are rare.

Tell your doctor immediately if you or your child notice any of the following:

  • tingling or numbness.

The following are very serious side effects and you or your child may need urgent medical attention or hospitalisation. All of these side effects are rare.

If any of the following happen to you or your child, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • An allergic reaction: Typical symptoms include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body
  • shortness of breath, wheezing or trouble breathing
  • a fit, convulsion or seizure, including convulsion associated with fever
  • bleeding or bruising more easily than normal
  • little or no urine
  • severe stabbing or throbbing nerve pain
  • neck stiffness, headache and high temperature associated with hallucinations, confusion, paralysis of part or all of the body, disturbances of behaviour, speech and eye movements, and sensitivity to light.

Very rarely, a serious disorder called Guillain-Barré syndrome (GBS) may occur. GBS is an autoimmune syndrome caused by your body’s own immune system. GBS may make you feel weak; you may have difficulty moving around or you may experience numbness and tingling in your limbs.

Other side effects not listed may occur in some people. Tell your doctor, nurse or pharmacist if you or your child notice anything that makes you or your child feel unwell.

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

Storing Afluria® Quad vaccine

Afluria® Quad vaccine is usually stored in the doctor’s surgery or clinic, or at the pharmacy.

If you need to store Afluria® Quad vaccine:

  • Keep it where children cannot reach it
  • Keep it in the refrigerator, between 2°C and 8°C. Do not freeze Afluria® Quad vaccine. Protect it from light.
    Note:
    Freezing destroys the vaccine.
  • Keep Afluria® Quad vaccine in the original pack until it is time for it to be given.

Afluria® Quad vaccine should not be used after the expiry date on the packaging.

Product description

What it looks like

Afluria® Quad vaccine is supplied in a glass pre-filled disposable syringe with or without a needle for single use only. Your doctor, nurse or pharmacist will give you or your child the injection.

Afluria® Quad vaccine is supplied in pack sizes of one or ten syringes. Not all presentations or pack sizes may be marketed.

Ingredients

Active ingredients:

Purified, inactivated virus fragments from influenza types:

  • H1N1 strain 15 micrograms
  • H3N2 strain 15 micrograms
  • B strain 15 micrograms
  • B strain 15 micrograms

for the Southern Hemisphere winter season 2020.

Other ingredients

  • Sodium chloride
  • Dibasic sodium phosphate
  • Monobasic sodium phosphate
  • Potassium chloride
  • Monobasic potassium phosphate
  • Calcium chloride dihydrate
  • Water for injections

Afluria® Quad vaccine may also contain trace amounts of detergent (sodium taurodeoxycholate), egg protein (ovalbumin), sucrose, neomycin sulfate, polymyxin B sulfate, propiolactone and hydrocortisone.

Afluria® Quad vaccine does not contain lactose, gluten, tartrazine, any azo dyes, or latex.

Ask your doctor, nurse or pharmacist if you are unsure about anything or want more information about Afluria® Quad vaccine.

Name and Address of Sponsor

Seqirus Pty Ltd
ABN 26 160 735 035
63 Poplar Road
Parkville
Victoria 3052
AUSTRALIA

Registration numbers

AUST R 262428

AUST R 294907

Date of preparation

07 October 2019

AFLURIA® and Fluvax® are registered trademarks of Seqirus UK Limited or its affiliates.

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Afluria Quad

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

S4

 

1 Name of Medicine

Afluria Quad.
Inactivated quadrivalent influenza vaccine (split virion) suspension for injection; containing influenza virus haemagglutinin as active ingredient.

6.7 Physicochemical Properties

Not applicable.

2 Qualitative and Quantitative Composition

For season 2020.
This is a purified, inactivated, split virion (split virus) vaccine. Each 0.5 mL dose contains antigens for the 2020 influenza season representative of the following types:
A/Brisbane/02/2018 (H1N1) pdm09 - like virus (A/Brisbane/02/2018 (IVR-190)): 15 microgram HA* per dose.
A/South Australia/34/2019 (H3N2) - like virus (A/South Australia/34/2019 (IVR-197)): 15 microgram HA* per dose.
B/Washington/02/2019 - like virus (B/Victoria/705/2018 BVR-11): 15 microgram HA* per dose.
B/Phuket/3073/2013 - like virus (B/Phuket/3073/2013 (BVR-1B)): 15 microgram HA* per dose.
*HA = haemagglutinin.
Afluria Quad is manufactured in eggs and trace amounts of sodium taurodeoxycholate (TDOC) (≤5 microgram), ovalbumin (< 1 microgram/0.5 mL dose), sucrose, neomycin sulfate, polymyxin B sulfate, propiolactone and hydrocortisone may be present. For the full list of excipients, see Section 6.1 List of Excipients.
The type and amount of viral antigens in Afluria Quad vaccine conform to the requirements of the Australian Influenza Vaccine Committee for the winter of 2020. The strains chosen for vaccine manufacture are endorsed by the Australian Influenza Vaccine Committee as being antigenically equivalent to the reference virus.
The vaccine is prepared from virus grown in the allantoic cavity of embryonated eggs, purified by zonal centrifugation, inactivated by propiolactone and disrupted by TDOC. Afluria Quad vaccine conforms in safety and sterility to the requirements of the British Pharmacopoeia.

3 Pharmaceutical Form

Suspension for injection. Afluria Quad vaccine is a clear to slightly opaque liquid with some sediment that resuspends upon shaking.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Afluria Quad vaccine has been shown to induce antibodies to the viral surface glycoprotein, haemagglutinin. These antibodies are important in the prevention of natural infection.
Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus. In some human studies, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects. Antibodies against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.
Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus change from year to year.

Clinical trials.

Adult studies.

One clinical study has been completed with Afluria Quad vaccine in adults 18 years and older.
QIV-01 (NCT02214225, see http://clinicaltrials.gov) was a randomised, double blind, active comparator controlled trial conducted in the US in adults aged 18 years and older. Subjects in the per protocol population that was used for the primary immunogenicity analysis received one dose of either Afluria Quad vaccine (N = 1691) or one of two formulations of comparator trivalent influenza vaccine (TIV-1 N = 854 or TIV-2 N = 850), each containing an influenza type B virus that corresponded to one of the two B viruses in Afluria Quad vaccine (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The mean age of the enrolled population was 58 years. 57% were female, 82% were white and 16% black/ African American. The age subgroups were 18 to < 65 years and ≥ 65 years with a mean age of 43 years and 73 years, respectively. Postvaccination immunogenicity was evaluated on sera obtained 21 days after administration of a single dose of Afluria Quad vaccine or TIV.
The coprimary endpoints were HI geometric mean titre (GMT) ratios (adjusted for baseline HI titres) and the difference in seroconversion rates for each vaccine strain, 21 days after the vaccination. Prespecified noninferiority criteria required that the upper bound of the 2-sided 95% CI of the GMT ratio (TIV/Afluria Quad vaccine) did not exceed 1.5 and the upper bound of the 2-sided 95% CI of the seroconversion rate difference (TIV minus Afluria Quad vaccine) did not exceed 10% for each strain.
Serum HI antibody responses to Afluria Quad vaccine were noninferior to both TIVs for all influenza strains. Additionally, noninferiority was demonstrated for both endpoints in both age subgroups, adults aged 18 to < 65 years and ≥ 65 years (see Table 4), for all strains. Antibody responses were lower in adults aged ≥ 65 years.
Superiority of the immune response to each of the influenza B strains contained in Afluria Quad vaccine was shown relative to the antibody response after vaccination with TIV formulations not containing that B lineage strain. Superiority against the alternate B strain was also demonstrated for each of the influenza B strains in both age subgroups; 18 to < 65 years and ≥ 65 years.
Post hoc analyses of immunogenicity by gender did not demonstrate significant differences between males and females. The study population was not sufficiently diverse to assess differences between races or ethnicities.

Paediatric studies.

One clinical study has been completed with Afluria Quad vaccine in children aged 5 to < 18 years of age.
QIV-02 (NCT02545543, see http://clinicaltrials.gov) was a randomised, observer-blinded, comparator-controlled trial conducted in the US in children 5 to < 18 years of age. Subjects received either one or two doses of either Afluria Quad vaccine (N=1605) or a comparator quadrivalent influenza vaccine (N=528) in a 3:1 randomisation treatment schedule. Subjects 5 to < 9 years of age were eligible to receive a second dose at least 28 days after the first dose depending on their influenza vaccination history. Approximately 25% of subjects in each treatment group in the 5 to < 9 years of age sub-group received two vaccine doses. Baseline serology prior to vaccination and sera obtained 28 days after the last vaccination dose was collected and immunogenicity was evaluated by HI assay.
The co-primary endpoints were HI geometric mean titres (GMT) (adjusted for baseline HI titres and other covariates) and seroconversion rates for each vaccine strain, 28 days after the last vaccination. Pre-specified non-inferiority criteria required that the upper bound of the 2-sided 95% CI of the GMT ratio (comparator QIV/ Afluria Quad vaccine) did not exceed 1.5 and the upper bound of the 2-sided 95% CI of the seroconversion rate difference (comparator QIV minus Afluria Quad vaccine) did not exceed 10% for each strain.
Serum HI antibody responses to Afluria Quad vaccine were non-inferior for both GMT and seroconversion rates relative to the comparator QIV for all influenza strains (Table 5). Analyses of immunogenicity endpoints by gender did not demonstrate meaningful differences between males and females. The study population was not sufficiently diverse to assess differences between races or ethnicities.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No nonclinical studies have been conducted with Afluria Quad vaccine. A rat reproductive and developmental toxicity study has been conducted with Fluvax TIV. This study did not demonstrate any maternal or developmental toxicity.

Genotoxicity.

Afluria Quad vaccine has not been evaluated for genotoxic potential.

Carcinogenicity.

Afluria Quad vaccine has not been evaluated for carcinogenic potential.

4 Clinical Particulars

4.1 Therapeutic Indications

For the prevention of influenza caused by influenza virus, types A and B contained in the vaccine. The vaccine is indicated for use only in persons aged 5 years and over.
For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

4.3 Contraindications

Afluria Quad vaccine is contraindicated in children less than 5 years of age because the safety and efficacy in this age group has not been evaluated.
Afluria Quad vaccine is contraindicated in individuals who have previously experienced:
anaphylaxis following a dose of any influenza vaccine;
anaphylaxis following exposure to any component of the vaccine, excluding egg protein (see Section 2 Qualitative and Quantitative Composition; Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Afluria Quad vaccine is not indicated for use in children less than 5 years of age (see Paediatric use).
As with other injectable vaccines, appropriate medical treatment and supervision should always be available to manage the rare event of an anaphylactic reaction following administration of the vaccine. Persons with a history of anaphylaxis to egg should be vaccinated only in medical facilities with staff experienced in recognising and treating anaphylaxis. For full details regarding recommendations for influenza vaccination in individuals with egg allergy, please refer to the relevant national immunisation guidelines.
Adrenaline should always be ready for immediate use whenever any injection is given.
Immunisation should be postponed in patients with acute febrile illness until the fever is resolved.
In immunocompromised patients the antibody response may be lower.
If Guillain-Barré syndrome has occurred within 6 weeks of previous influenza vaccination, the decision to give Afluria Quad vaccine should be based on careful consideration of the potential benefits and risks.

Use in the elderly.

The safety and immunogenicity of Afluria Quad vaccine was evaluated in adults ≥ 65 years in QIV-01 (see Section 4.8 Adverse Effects (Undesirable Effects); Section 5.1 Pharmacodynamic Properties, Clinical trials). There were 541 enrolled subjects aged 65 to < 75 years and 329 enrolled subjects ≥ 75 years. Antibody responses to Afluria Quad vaccine were noninferior to comparator trivalent influenza (TIV-1 and TIV-2) responses in adults ≥ 65 years of age, and lower than in younger adults.

Paediatric use.

Afluria Quad vaccine is not indicated in children less than 5 years of age.
Administration of the 2010 Southern Hemisphere trivalent influenza vaccine (Fluvax TIV, manufactured by CSL, now Seqirus Pty Ltd) was associated with increased rates of fever and febrile convulsions, predominantly in children below the age of 5 years as compared to previous years.
Following a comprehensive investigation into the 2010 Southern Hemisphere adverse events, Seqirus has modified the manufacturing conditions. A clinical program has subsequently been conducted with Afluria Quad in adults, and children aged 6 months to less than 18 years. Fever rates in children were lower than those observed in clinical studies conducted prior to 2010 and no related febrile convulsions were reported.

Effects on laboratory tests.

Interference of Afluria Quad vaccine with laboratory and/or diagnostic tests has not been studied.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed on interaction between influenza vaccines in general and other vaccines or medications.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Afluria Quad vaccine has not been evaluated for possible effect on fertility.
A reproductive study of female rats vaccinated with Seqirus' trivalent influenza vaccine (Fluvax TIV) revealed no impairment of fertility.
(Category A)
No embryofoetal development study has been conducted with Afluria Quad vaccine. A rat reproduction study has been conducted with Seqirus' trivalent influenza vaccine (Fluvax TIV). This study did not demonstrate any maternal or developmental toxicity.
Influenza vaccination is recommended for pregnant women during any stage of pregnancy. This recommendation is based on the known adverse consequences of influenza infection during pregnancy and the large body of data showing that large numbers of women have been vaccinated during pregnancy with inactivated influenza vaccines with no increased risk of adverse foetal or maternal outcomes attributable to the vaccine. Afluria Quad vaccine should be given to a pregnant woman following an assessment of the risks and benefits.
The safety and effectiveness of Afluria Quad vaccine has not been evaluated in nursing mothers.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in the clinical studies of another vaccine and may not reflect the rates of events observed in clinical practice.
Two clinical studies with Afluria Quad vaccine have been completed.
QIV-01 (NCT02214225, see http://clinicaltrials.gov) was a randomised, double blind, active controlled trial conducted in the US in 3449 subjects aged ≥ 18 years. Subjects in the safety population received one dose of either Afluria Quad vaccine (N = 1721) or one of two formulations of comparator trivalent influenza vaccine (TIV-1 N = 864 or TIV-2 N = 864) each containing an influenza type B virus that corresponded to one of the two B viruses in Afluria Quad vaccine (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage).
Local (injection site) adverse reactions and systemic adverse events were solicited for 7 days postvaccination (see Table 2). Unsolicited adverse events were collected for 28 days postvaccination. Serious adverse events were collected for 180 days postvaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.
QIV-02 (NCT02545543, see http://clinicaltrials.gov) was a randomised, observer-blind, comparator-controlled trial that evaluated the immunogenicity and safety of Afluria Quad vaccine in subjects aged 5 to < 18 years with a 2015-2016 comparator quadrivalent influenza vaccine. Study subjects were scheduled to receive either a single vaccination or two-vaccination regimen as clinically indicated. Local (injection site) adverse reactions and systemic adverse events were solicited for 7 days post vaccination (see Table 3). Unsolicited adverse events and cellulitis-like reactions at the injection site were collected for 28 days after the last vaccination; and serious adverse events for six months following last vaccination.

Adult data.

In adults 18 to < 65 years, the most commonly reported injection site adverse reaction observed in clinical studies with Afluria Quad vaccine was pain (≥ 40%). The most common systemic adverse events observed were myalgia and headache (≥ 20%). In adults ≥ 65 years of age, the most commonly reported injection site adverse reaction observed in clinical studies with Afluria Quad vaccine was pain (≥ 20%). The most common systemic adverse event observed was myalgia (≥ 10%). A small number of adults ≥ 65 years of age (n = 4) experienced severe injection site swelling.
In adults 18 to < 65 years who received Afluria Quad vaccine, commonly reported unsolicited adverse events were headache (5.3%), oropharyngeal pain (2.5%), back pain (1.9%), diarrhoea (1.6%), cough (1.3%) and nausea (1.1%). In adults ≥ 65 years who received Afluria Quad vaccine, commonly reported unsolicited adverse events were headache (2.3%), rhinorrhoea (1.3%), oropharyngeal pain (1.2%) and back pain (1.2%).

Paediatric data.

Afluria Quad vaccine was administered to children 5 to < 18 years of age in Study QIV-02.
In children 5 to < 18 years, the most common (≥ 10%) injection site reactions were pain (51.4%), redness (17.1%), and induration/ swelling (13.8%); the most common solicited systemic adverse events were headache (15.5%) and myalgia (13.1%).
There were no vaccine-related deaths reported in this paediatric study QIV-02. There was one vaccine-related serious adverse event (influenza) reported in this study.
One subject experienced a cellulitis-like reaction (defined as concurrent severe pain, redness and swelling) at the injection site after vaccination with Afluria Quad vaccine.
In children 5 to < 18 years administered Afluria Quad vaccine, cough (2.1%) was the most commonly reported unsolicited adverse event. Other commonly reported unsolicited adverse events (reported by ≥ 1% of subjects) were oropharyngeal pain (1.3%), pyrexia (1.3%) and upper respiratory tract infection (1.1%).
The most commonly reported unsolicited adverse events among subjects who received Afluria Quad vaccine in ages 5 to < 9 years following the first or second dose included cough (2.8%), pyrexia (2.1%), headache (1.2%), rhinorrhoea (1.2%), upper respiratory tract infection (1.2%), influenza-like illness (1.0%), and oropharyngeal pain (1.0%).
For subjects aged 9 to < 18 years who received Afluria Quad vaccine, the most common unsolicited adverse events included oropharyngeal pain (1.6%), cough (1.3%), and upper respiratory tract infection (1.0%).

Postmarketing surveillance.

There are limited postmarketing data available for Afluria Quad vaccine.
The Afluria Quad vaccine formulation is based on Seqirus' trivalent influenza vaccine (Fluvax TIV), with the exception of an additional B influenza strain.
The adverse events spontaneously reported during post approval use of Fluvax TIV are presented below.

Blood and lymphatic system disorders.

Thrombocytopoenia.

Immune system disorders.

Allergic or immediate hypersensitivity reactions including anaphylactic shock.

Nervous system disorders.

Neuralgia, paraesthesia and convulsions (including febrile convulsions), encephalomyelitis, neuritis or neuropathy, and Guillain-Barré syndrome.

Vascular disorders.

Vasculitis which may be associated with transient renal involvement.

Skin and subcutaneous tissue disorders.

Pruritus, urticaria and rash.

General disorders and administration site conditions.

Cellulitis and large injection site swelling.
Influenza-like illness.

Reporting suspected adverse reactions.

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 http://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Immunisation should be undertaken in anticipation of seasonal outbreaks of influenza.

Dose.

See Table 1.
To provide continuing protection, annual vaccination with vaccine containing the most recent strains is necessary.

Method of administration.

Afluria Quad vaccine should be administered by a health care practitioner in an appropriate setting with an appropriate postvaccination observation period.
Shake before use. After shaking, the vaccine should appear as a clear to slightly opaque homogenous suspension. The vaccine must be inspected visually prior to administration and should not be used if there is any variation of physical appearance. See Section 3 Pharmaceutical Form.
The vaccine should be administered by intramuscular or deep subcutaneous injection.
Afluria Quad vaccine can be administered concurrently with other vaccines, however separate syringes and a separate arm should be used.
Persons with a history of egg allergy (non-anaphylaxis) can receive an age-appropriate full dose of vaccine in any immunisation setting [also see Section 4.4 Special Warnings and Precautions for Use].

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

There is no specific information on overdose of influenza vaccines.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) or the New Zealand Poisons Centre on 0800 POISON or 0800 764 766 (New Zealand).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 0.5 mL dose contains the following excipients. See Table 6.
Also see Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Afluria Quad vaccine should be stored, protected from light, at 2°C to 8°C. It must not be frozen.

6.5 Nature and Contents of Container

Afluria Quad vaccine is supplied in a single-dose 0.5 mL pre-filled type 1 glass syringe.

AUST R 262428.

Afluria Quad inactivated quadrivalent influenza vaccine (split virion), 60 mcg HA, suspension for injection, pre-filled syringe (AUST R 262428) is a 0.5 mL suspension for injection in a pre-filled syringe (type I glass) with attached needle.
Pack sizes: 1's; 10's.

AUST R 294907.

Afluria Quad inactivated quadrivalent influenza vaccine (split virion), 60 mcg HA, suspension for injection, pre-filled syringe needle free (AUST R 294907) is a 0.5 mL suspension for injection in a needle-free pre-filled syringe (type I glass).
Pack sizes: 1's, 10's.
The syringe and all associated syringe components for Afluria Quad (AUST R 262428 and AUST R 294907) do not contain natural rubber latex.
Not all presentations or pack sizes may be marketed.

6.6 Special Precautions for Disposal

Afluria Quad vaccine is presented as a single-use syringe and any remaining contents should be discarded in accordance with local requirements.

Summary Table of Changes