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

SUMMARY CMI

Afluria^® Quad

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor, nurse or pharmacist.

WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.

1. Why am I using Afluria^® Quad?

Afluria^® Quad contains the active ingredient influenza virus haemagglutinin. Afluria^® Quad is a vaccine that helps prevent influenza, often called ‘the flu’. Afluria^® Quad is indicated for use only in persons aged 5 years and over.

For more information, see Section 1. Why am I using Afluria^® Quad? in the full CMI.

2. What should I know before being given Afluria^® Quad?

Tell your doctor, nurse or pharmacist if you or your child have ever had an allergic reaction to Afluria^® Quad or any of the ingredients listed at the end of the CMI or any other influenza vaccine.

Talk to your doctor if you or your child have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before being given Afluria^® Quad? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Afluria^® Quad and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Afluria^® Quad given?

Afluria^® Quad is given as an injection, usually into the muscle or under the skin of your upper arm by a doctor, nurse or pharmacist.
Afluria^® Quad is given once every year for adults and children 5 years and over in 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 is given at least 4 weeks after the first dose.

More instructions can be found in Section 4. How is Afluria^® Quad given? in the full CMI.

5. What should I know about being given Afluria^® Quad?

Things you should do

Call your doctor straight away if you or your child do not feel well after having Afluria^® Quad.

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

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

For more information, see Section 5. What should I know about being given Afluria^® Quad? in the full CMI.

6. Are there any side effects?

Common side effects may include local reaction around the injection site, flu-like symptoms and muscle pain. Mostly these are mild and usually disappear within 3 days without treatment. Serious side effects are rare.

Sudden signs of allergy may be a serious side effect. If you experience this, tell your doctor immediately. Typical symptoms include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

WARNING: Afluria^® Quad vaccine is indicated for use only in persons aged 5 years and over. It must not be used in persons under 5 years

FULL CMI

Afluria^® Quad

Active ingredient(s): influenza virus haemagglutinin

Consumer Medicine Information (CMI)

This leaflet provides important information about using Afluria^® Quad. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about using Afluria^® Quad.

Where to find information in this leaflet:

1. Why am I using Afluria^® Quad?
2. What should I know before being given Afluria^® Quad?
3. What if I am taking other medicines?
4. How is Afluria^® Quad given?
5. What should I know about being given Afluria^® Quad?
6. Are there any side effects?
7. Product details

1. Why am I using Afluria^® Quad?

Afluria^® Quad contains the active ingredient influenza virus haemagglutinin.

Afluria^® Quad is a vaccine used to help prevent certain types of influenza or “flu”. It is for use in people aged 5 years and over.

Influenza is caused by infection with specific influenza viruses. New types of influenza viruses can appear each year. Afluria^® Quad 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 does not contain.

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

Afluria^® Quad 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. 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 is very small. Whereas, the risks of not being vaccinated against influenza may be very serious.

2. What should I know before being given Afluria^® Quad?

Warnings

Your child must not be given Afluria^® Quad if they are under 5 years old. For the 2022 influenza season, Afluria^® Quad is only for use in persons aged 5 years and over.

Do not use Afluria^® Quad if:

you or your child are severely allergic to any of the ingredients listed at the end of this leaflet or to any previous influenza vaccine. 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.

Always check the ingredients to make sure you can use this vaccine.

Do not have Afluria^® Quad if you or your child have/has a temperature higher than 38.5°C.

Tell your doctor if 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.

have/has an infection or temperature higher than 38.5°C.

have/has any other 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.

have/has allergy to

any other medicines,
to eggs, or egg proteins,
or any other substances, such as latex, food, preservatives or dyes.

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 but talk to your doctor about this if being vaccinated. Your doctor will decide if you can receive Afluria^® Quad.

After vaccination you or your child may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Influenza vaccination is recommended for pregnant women during any stage of pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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

3. What if I am taking other medicines?

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

Some medicines may interfere with Afluria^® Quad and affect how it works. These include medicines which affect the body's immune response, such as corticosteroids, cyclosporin or some treatments for cancer (including radiation therapy).

Tell your doctor if you or your child have had any vaccines in the last 4 weeks. Afluria^® Quad can be given at the same time as other vaccines.

Check with your doctor, nurse or pharmacist if you are not sure about what medicines, vitamins or supplements you or your child are taking and if these affect Afluria^® Quad.

4. How is Afluria^® Quad given?

How much is given

Afluria^® Quad is given as a single 0.5 mL dose for adults and children 5 years and over once every year.

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 is given at least 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.

When Afluria^® Quad is given

Afluria^® Quad 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.

How is Afluria^® Quad given

It is given as an injection usually into the muscle or under the skin of your upper arm.

5. What should I know about having Afluria^® Quad?

Things you should do

Call your doctor straight away if you or your child do not feel well after having Afluria^® Quad.

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

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

Driving or using machines

Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.

Looking after your medicine

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

If you need to store Afluria^® Quad:

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

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal. A doctor, nurse or pharmacist will dispose of any unused vaccine.

Do not use Afluria^® Quad after the expiry date.

6. Are there any side effects?

All vaccines can have side effects. If you or your child do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

The 2010 formulation of Fluvax^® trivalent (three strain) influenza vaccine (manufactured by CSL, now 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 if they are under 5 years old as safety in this age group has not been established.

Less serious side effects

Less serious side effects	What to do
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.	Speak to your doctor if you or your child have any of these less serious side effects and they worry you. Mostly these are mild and short-lived.

Serious side effects

Serious side effects

What to do

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,
tingling or numbness,
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.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you or your child notice any of these serious side effects.
All of these serious side effects are rare

Other side effects not listed here 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.

Reporting side effects

After you have received medical advice for any side effects you or your child experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this vaccine.

7. Product details

Afluria^® Quad is only available with a doctor's prescription.

What Afluria^® Quad contains

Active ingredient (main ingredient)	Influenza virus haemagglutinin Each 0.5 mL contains 15 micrograms from each of the following types of influenza virus: A/Victoria/2570/2019 (H1N1)pdm09-like strain A/Darwin/9/2021 (H3N2)-like strain B/Austria/1359417/2021-like strain B/Phuket/3073/2013-like strain. These strains have been recommended by the Australian Influenza Vaccine Committee for the 2022 Southern Hemisphere winter.
Other ingredients (inactive ingredients)	Sodium chloride, Dibasic sodium phosphate, Monobasic sodium phosphate, Potassium chloride, Monobasic potassium phosphate, Calcium chloride dihydrate, Water for injections Afluria^® Quad may also contain trace amounts of detergent (sodium taurodeoxycholate), egg protein (ovalbumin), sucrose, neomycin sulfate, polymyxin B sulfate, propiolactone and hydrocortisone.

Tell your doctor if you or your child have/has allergy to any of the above ingredients. Your doctor will decide if you can receive Afluria^® Quad.

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

What Afluria^® Quad looks like

Afluria^® Quad is a clear to slightly opaque liquid, with some sediment that resuspends upon shaking, in glass pre-filled syringe with or without a needle for single use only. (AUST R 262428 and AUST R 294907).

Who distributes Afluria^® Quad

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

This leaflet was prepared in October 2021.

Afluria^® Quad and Fluvax^® are trademarks of Seqirus UK Limited or its affiliates.

Published by MIMS March 2022

BRAND INFORMATION

Brand name

Afluria Quad

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

1 Name of Medicine

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

2 Qualitative and Quantitative Composition

For season 2022.
This is a purified, inactivated, split virion (split virus) vaccine. Each 0.5 mL dose contains antigens for the 2022 influenza season representative of the following types:
A/Victoria/2570/2019 (H1N1)pdm09-like virus (A/Victoria/2570/2019 IVR-215): 15 microgram HA* per dose.
A/Darwin/9/2021 (H3N2)-like virus (A/Darwin/6/2021 IVR-227): 15 microgram HA* per dose.
B/Austria/1359417/2021-like virus (B/Austria/1359417/2021 BVR-26): 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 2022. 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.

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.

4.2 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].
Each pre-filled syringe is for use in one patient on one occasion only. Discard any residue.

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).

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-Barre 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, 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) 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). 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.

4.7 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.

4.8 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%).

Post-marketing surveillance.

The Afluria Quad vaccine formulation is based on Seqirus' trivalent influenza vaccine (Fluvax), with the exception of an additional B influenza strain.
The adverse events spontaneously reported during post approval use of Fluvax and/or Afluria Quad are presented below.

Blood and lymphatic system disorders.

Thrombocytopenia.

Immune system disorders.

Allergic or immediate hypersensitivity reactions including anaphylactic shock.

Nervous system disorders.

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

Vascular disorders.

Vasculitis which may be associated with renal involvement.

Musculoskeletal and connective tissue disorders.

Musculoskeletal pain and pain in extremity.

Skin and subcutaneous tissue disorders.

Pruritus, urticaria and rash.

General disorders and administration site conditions.

Cellulitis and large injection site swelling, influenza-like illness injected limb mobility decreased, pyrexia, injection site erythema and injection site reaction.

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.

4.9 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).

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 Seqirus' trivalent influenza vaccine, Fluvax. 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.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 0.5 mL dose contains the following excipients. See Table 6.
Afluria Quad does not contain any preservative.
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

Store at 2°C to 8°C (Refrigerate. Do not freeze). Protect from light. Discard if the vaccine has been 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.

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Afluria Quad

Influenza virus vaccine, split virion, quadrivalent (inactivated)

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