Consumer medicine information

Flucelvax Quad

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

BRAND INFORMATION

Brand name

Flucelvax Quad

Active ingredient

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions about Flucelvax® Quad.

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 has weighed the risks of you having Flucelvax® Quad against the benefits they expect it will have for you or your child.

If you have any concerns about Flucelvax® Quad, ask your doctor, nurse or pharmacist.

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

What Flucelvax® Quad is used for

Flucelvax® Quad is a vaccine used to help prevent certain types of influenza or “flu”. It is recommended for people aged 9 years of age and older.

Influenza is a sudden respiratory infection caused by a virus. It is usually spread from one person to another by small droplets from coughs and sneezes. The virus enters the nose or throat and may spread to the lungs. It is very contagious. There are several kinds of influenza viruses however they all produce similar illness. Influenza is characterised by a sudden onset of headache, generalised aches and pain, fever that may be followed by a sore throat, a cough and a runny nose.

The severity and types of symptoms can vary. Most people recover in about a week; however, infection with influenza in some people can lead to serious illness, especially those who are “run down” or are in poor health.

Vaccination against influenza helps prevent infection with influenza and to control the spread of the disease.

How it works

Flucelvax® Quad works by causing your body to produce its own protection against the four types of influenza virus from which it is made. It does this by making substances called antibodies in the blood that fight the influenza virus. If a vaccinated person comes into contact with the influenza virus, the body is usually ready to destroy it.

Your body usually takes 2 – 3 weeks after vaccination to develop protection against influenza.

As influenza viruses can change from year to year, Flucelvax® Quad may be changed to contain fragments of the new types of virus. Therefore vaccination is required yearly.

Please note that an influenza vaccine may only protect you against the types of influenza virus from which it is made. It will not protect you from other types of influenza virus or from infections with other agents causing flu-like symptoms (such as the common cold).

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

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

Before you or your child are given Flucelvax® Quad

When you or your child must not be given Flucelvax® Quad

Do not have Flucelvax® Quad if you or your child has previously had a severe allergy to:

  • any of the ingredients listed at the end of this leaflet
  • any 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
  • skin rash, itching or hives.

Do not have Flucelvax® Quad if you or your child have a high temperature or sudden illness.

A minor illness such as a cold should not be a problem but talk to your doctor about this if being vaccinated.

Do not have Flucelvax® Quad if your child is under 9 years old. Flucelvax® Quad is not recommended for use in persons under 9 years.

Do not have Flucelvax® Quad after the expiry date printed on the pack.

Do not have Flucelvax® Quad if the packaging is torn or shows signs of tampering.

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

Before you or your child are given Flucelvax® Quad

Tell your doctor if you or your child have reacted to previous vaccination with any of the following:

  • severe allergic reaction (anaphylaxis)
  • difficulty breathing
  • swelling of the throat
  • fainting or collapse
  • shock-like state or being unresponsive for a long period of time
  • fits or convulsions
  • temperature (greater than 38°C) or high temperature (greater than 39°C)
  • severe skin reaction at the injection site, including severe bruising

Tell your doctor if you or your child have an infection or high temperature. Your doctor may decide to delay vaccination until the illness has passed. A mild illness, such as a cold, is not usually a reason to delay vaccination.

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

  • Guillain-Barre Syndrome (an inflammatory illness affecting nerves resulting in weakness of muscles)
  • lowered immunity due to diseases such as some blood disorders, malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
  • lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy)

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 Flucelvax ® Quad vaccine during pregnancy, and advise on the timing of Flucelvax ® 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 Flucelvax ® Quad vaccine while you are breast-feeding.

Taking other medicines

Tell your doctor 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 Flucelvax® Quad may interfere with each other. These include:

  • immunoglobulins, blood products used to prevent some infections
  • medicines which lower the immune system, such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy).

Your doctor will consider whether an adjustment of medication is necessary.

Having other vaccines

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

Your doctor will decide if Flucelvax® Quad may be given with another vaccine.

Your doctor and pharmacist may have more information on medicines and vaccines to be careful with or to avoid during vaccination with Flucelvax® Quad.

How Flucelvax® Quad is given

Flucelvax® Quad is given as an injection, usually into your upper arm muscle by a doctor or nurse.

How much is given

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

  • Adults and children 9 years and over: one injection of 0.5 mL

When it is given

Flucelvax® Quad vaccine is usually given before the start of the influenza season or when recommended by your doctor or nurse.

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

After having Flucelvax® Quad

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.

Have any blood tests when your doctor says to. Your doctor may wish to test your body’s response to Flucelvax® Quad to make sure that you have developed protection against influenza.

Things to be careful of

Be careful driving or operating machinery until you know how Flucelvax® Quad affects you. Flucelvax® Quad should not normally interfere with your ability to drive or operate machinery. However, it may cause tiredness in some people.

Side effects

Tell your doctor or pharmacist as soon as possible if you or your child do not feel well after having Flucelvax® Quad. Flucelvax® Quad 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 if you get some of the side effects.

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

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

These are the more common side effects of Flucelvax® Quad. Mostly these are mild and short lived.

  • local reaction around the injection site such as pain, redness, swelling or the formation of hard lumps and bruising
  • muscle aches or joint pain (not caused by exercise)
  • flu-like symptoms, such as headache, tiredness, fever, sore throat, runny nose, blocked nose, sneezing, cough, chills
  • nausea, vomiting, diarrhoea
  • loss of appetite

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

These may be serious side effects. You or your child may need urgent medical attention. These serious side effects are rare.

  • tingling of the hands or feet, or sudden numbness or weakness in the legs or arms
  • extensive swelling of the injected limb
  • generalised skin reactions including itching, bumps on the skin or non-specific rash

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

  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, (anaphylaxis)
  • shortness of breath, wheezing or trouble breathing
  • feeling weak or paralysed, or generally feeling sore or tender
  • rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting (shock)

These are very serious side effects. You or your child may need urgent medical attention or hospitalisation.

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.

All of these side effects are rare.

Other side effects not listed above may occur in some patients. Tell your doctor, nurse or pharmacist if you notice anything that is making 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 Flucelvax® Quad

Flucelvax® Quad is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However, if you need to store Flucelvax® Quad:

  • Keep it where children cannot reach it.
  • Keep Flucelvax® Quad in the original pack until it is time for it to be given.
  • Keep it in the refrigerator, between 2°C and 8°C. Do not freeze Flucelvax® Quad. Discard if the vaccine has been frozen.
    Freezing destroys the vaccine

Product description

What it looks like

Flucelvax® Quad is a clear to slightly milky-white liquid in a pre-filled syringe.

Ingredients

  • Active ingredients:
    Each 0.5 mL contains 15 micrograms of influenza virus fragments (influenza virus haemagglutinins) from each of the following types of influenza virus:
    - A/ Wisconsin/588/2019 (H1N1)pdm09 - like strain
    - A/ Hong Kong/45/2019 (H3N2) – like strain
    - B/ Washington/02/2019 - like strain
    - B/ Phuket/3073/2013 – like strain
    These strains have been recommended by the Australian Influenza Vaccine Committee for the 2021 Southern Hemisphere season.
  • Other ingredients:
    Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Dibasic sodium phosphate dihydrate, Dibasic potassium phosphate, Water for injections.

Flucelvax® Quad may also contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80, as residues of the manufacturing process.

Flucelvax® Quad does not contain lactose, gluten, tartrazine, any other azo dyes, antibiotics or preservative.

Manufacturer/Distributor/ Supplier

Flucelvax® Quad sponsored by:

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

AUST R 319093
AUST R 341450

Date of Revision:
12 October 2020

Flucelvax® Quad is a trademark of Seqirus UK Limited or its affiliates.

Published by MIMS December 2020

BRAND INFORMATION

Brand name

Flucelvax Quad

Active ingredient

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

Schedule

S4

 

1 Name of Medicine

Quadrivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures), suspension for injection containing Influenza virus haemagglutinin as active ingredient.

2 Qualitative and Quantitative Composition

This is a purified, inactivated, subunit influenza vaccine. Each 0.5 mL dose contains influenza virus surface antigens (haemagglutinin and neuraminidase)*, for the 2021 influenza season representative of the following types:
A/Wisconsin/588/2019 (H1N1)pdm09-like virus (A/Delaware/55/2019) 15 micrograms HA**;
A/Hong Kong/45/2019 (H3N2)-like virus (A/Delaware/39/2019) 15 micrograms HA**;
B/Washington/02/2019-like virus (B/Darwin/7/2019) 15 micrograms HA**;
B/Phuket/3073/2013-like virus (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**;
per 0.5 mL dose.
* Propagated in Madin Darby Canine Kidney (MDCK) cells.
** Haemagglutinin.
Flucelvax Quad is prepared in MDCK cells, adapted to grow freely in suspension in culture medium. The virus is inactivated with β-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. Therefore Flucelvax Quad may contain traces of propiolactone, cetyltrimethylammonium bromide, and polysorbate 80 (see Section 4.3 Contraindications). Eggs are not used in the manufacturing process, therefore, Flucelvax Quad does not contain egg proteins. For the full list of excipients, see Section 6.1 List of Excipients.
The vaccine complies with the World Health Organization (WHO) recommendation and Australian Influenza Vaccine Committee (AIVC) for the 2021 Southern Hemisphere Influenza season. The strains chosen for vaccine manufacture are endorsed by the AIVC as being antigenically equivalent to the reference virus.

3 Pharmaceutical Form

Flucelvax Quad is a clear to slightly opalescent suspension for injection.

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 in adults and children 9 years of age and older.
For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

4.2 Dose and Method of Administration

Dose.

Adults and children from 9 year of age.

A single 0.5 mL dose.

Method of administration.

Flucelvax Quad should be administered by intramuscular injection only. The vaccine must not be injected intravascularly, subcutaneously or intradermally.
The preferred site for intramuscular injection is the deltoid muscle of the upper arm.
Flucelvax Quad must not be mixed with other vaccines in the same syringe.
Shake before use. After shaking, the vaccine should appear as a clear to slightly opalescent suspension.
Visually inspect the contents of each pre-filled syringe for particulate matter and/or variation in appearance prior to administration. If either condition is observed, do not administer the vaccine.
Flucelvax Quad does not contain preservative or antibiotics. Each pre-filled syringe is for use in one patient on one occasion only. Discard any residue.

4.3 Contraindications

The vaccine is contraindicated in individuals with known severe allergic reactions (e.g. anaphylaxis) to:
any component of the vaccine (see Section 2 Qualitative and Quantitative Composition; Section 6.1 List of Excipients); or
a previous dose of any influenza vaccine.

4.4 Special Warnings and Precautions for Use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Immunisation should be postponed in patients with febrile illness or acute infection.
In immunocompromised patients the antibody response may be lower.
A protective immune response may not be elicited in all vaccine recipients.
If Guillain-Barré syndrome has occurred within 6 weeks of previous influenza vaccination, the decision to give Flucelvax Quad vaccine should be based on careful consideration of the potential benefits and risks.
The syringe and all associated syringe components for Flucelvax Quad AUST R 319093 pre-filled syringe needle-free do not contain natural rubber latex.
Flucelvax Quad AUST R 341450 pre-filled syringe with attached needle cannot be considered to be latex-free as the sheath covering the needle may contain natural rubber latex. See Section 6.5 Nature and Contents of Container for further information.

Use in the elderly.

Of the total number of subjects who received one dose of Flucelvax Quad in clinical studies and included in the safety population (2493), 26.47% (660) were 65 years of age and older and 7.7% (194) were 75 years of age or older.
Antibody responses to Flucelvax Quad were lower in the geriatric (adults 65 years and older) population than in younger subjects.

Paediatric use.

Flucelvax Quad is not indicated in children less than 9 years of age.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are no data available on co-administration of Flucelvax Quad with other vaccines. Based on clinical experience with cell-based trivalent influenza vaccine (TIVc), Flucelvax Quad can be given at the same time as other vaccines. If Flucelvax Quad is to be given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered to separate limbs. It should be noted that adverse reactions may be intensified.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no reproductive and developmental toxicity studies with Flucelvax Quad.
A reproductive and developmental toxicity study in which female rabbits were administered cell-based TIVc, 45 microgram HA/dose, 3 times prior to mating and twice during gestation, showed no adverse effects on the mating performance or female fertility. Male fertility has not been assessed in animals.
(Category B1)
The safety of Flucelvax Quad in pregnancy has not been assessed in clinical trials.
There are no reproductive and developmental toxicity studies with Flucelvax Quad. Reproductive and developmental toxicity data from TIVc do not predict an increased risk of developmental abnormalities. In a reproductive and developmental toxicity study with TIVc, the effect of cell culture-derived antigens on embryo-foetal development was evaluated in pregnant rabbits. Anti-influenza antibodies were detected in treated rabbits and their offspring. No adverse effects on pregnancy or embryo-foetal development were observed.
Healthcare providers should assess the benefit and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations. Refer to the current recommendations in the Australian Immunisation Handbook (Australia) or relevant national immunisation recommendations (New Zealand) for use in pregnancy. In general, data from influenza vaccinations in pregnant women do not indicate adverse foetal and maternal outcomes attributable to the vaccine.
Flucelvax Quad has not been evaluated in nursing mothers. No data are available on the use of Flucelvax Quad during lactation.

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 trials are conducted under very specific conditions, the adverse event rates observed in the clinical trials may not reflect the rates observed in the clinical studies of another vaccine and may not reflect the rates of events observed in clinical practice.

Adults 18 years of age and older.

The safety of Flucelvax Quad in adults 18 years and older was evaluated in a randomised, double-blind, controlled study conducted in the US (NCT01992094, see http://clinicaltrials.gov). The safety population included a total of 2680 adults 18 years of age and older; 1340 adults 18 to < 65 years of age and 1340 adults 65 years of age and older. In this study, subjects received Flucelvax Quad or one of the two formulations of comparator trivalent influenza vaccine (TIVc) (Flucelvax Quad N=1334, TIV1c N=677 or TIV2c N=669).
In this study, solicited local injection site and systemic adverse events were collected from subjects who completed a symptom diary card for 7 days following vaccination.
Unsolicited adverse events were collected for 21 days after vaccination. Serious adverse events (SAEs) were collected throughout the study duration (until 6 months after vaccination). All adverse events are presented regardless of any treatment causality assigned by study investigators.
Solicited adverse events in the safety population of adults 18 to < 65 years of age and 65 years of age and older are shown in Table 1.
The most commonly reported unsolicited adverse events (reported by ≥ 3% of subjects administered Flucelvax Quad) in adults 18 to < 65 years, were upper respiratory tract infection (3.5%) and nasopharyngitis (3.0%), and in adults ≥ 65 years, were nasopharyngitis (4.4%) and upper respiratory tract infection (3.3%).
There were no serious adverse events assessed as being related to study vaccines.

Children and adolescents 9 to less than 18 years of age.

Flucelvax Quad is indicated for use in adults and children 9 years of age and older (see Section 4.1 Therapeutic Indications).
The safety of Flucelvax Quad in children 4 to less than 18 years of age was evaluated in a randomised, double-blind, controlled study conducted in the US (NCT01992107, see http://clinicaltrials.gov). The safety population included a total of 2332 children 4 to less than 18 years of age; 1161 children 4 to less than 9 years of age and 1171 children 9 to less than 18 years of age.
In this study, subjects received Flucelvax Quad or one of the two formulations of comparator trivalent influenza vaccine (Flucelvax Quad N=1159, TIV1c N=593 or TIV2c N= 580). Children 9 to less than 18 years of age received a single dose of Flucelvax Quad or comparator vaccine. The collection and presentation of adverse events from this study is the same as the study in adults 18 years of age and older.
Solicited adverse events in the safety population of children 9 years to less than 18 years of age are shown in Table 2.
The most commonly reported unsolicited adverse event in children 9 to < 18 years, was upper respiratory tract infection (4.3%).
There were no serious adverse events assessed as being related to study vaccines.

Post-marketing adverse reactions.

The following events have been identified during post-approval use of Flucelvax Quad:

General disorders and administration site conditions.

Extensive swelling of injected limb.

Immune system disorders.

Allergic or immediate hypersensitivity reactions, including anaphylactic shock.

Nervous system disorders.

Paraesthesia.

Skin and subcutaneous tissue disorders.

Generalised skin reactions including pruritus, urticaria, or non-specific rash.

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/consumer-reporting/ (New Zealand).

4.9 Overdose

There is no experience of overdose with Flucelvax Quad.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) or the New Zealand Poisons Centre on 0800 POISON or 0800 767 4766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Influenza illness and its complications follow infection with influenza viruses. Global surveillance and analysis of influenza virus isolates permits identification of yearly antigenic variants. 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.
Antibody 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 current influenza vaccines is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus may change from year to year.

Clinical trials.

Immunogenicity of Flucelvax Quad.

Adult studies.

Immunogenicity of Flucelvax Quad was evaluated in adults 18 years of age and older in a randomised, double-blind, controlled study conducted in the US (NCT01992094, see http://clinicaltrials.gov). In this study, subjects received Flucelvax Quad or one of the two formulations of comparator trivalent influenza vaccine (Flucelvax Quad N=1334, TIV1c N=677 or TIV2c N=669). In the per protocol set, the mean age of subjects who received Flucelvax Quad was 57.5 years; 55.1% of subjects were female and 76.1% of subjects were Caucasian, 13% were Black and 9% were Hispanic. The immune response to each of the vaccine antigens was assessed, 21 days after vaccination.
The immune response of Flucelvax Quad was non-inferior to TIVc for all 4 influenza strains (GMT and differences in vaccine group seroconversion rates). The antibody response to influenza B strains contained in Flucelvax Quad was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage. There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.
Non-inferiority criteria were also met for all 4 influenza strains in age subgroup analyses for subjects 18 to less than 65 years of age and 65 years of age and above.
The non-inferiority data observed are summarised in Table 3.

Paediatric studies.

Immunogenicity of Flucelvax Quad was evaluated in children 4 to less than 18 years of age in a randomised, double-blind, controlled study conducted in the US (NCT01992107, see http://clinicaltrials.gov). In this study, subjects received Flucelvax Quad or one of the two formulations of comparator trivalent influenza vaccine (Flucelvax Quad N=1159, TIV1c N=593 or TIV2c N=580). In the per protocol set, the mean age of subjects who received Flucelvax Quad was 9.8 years; 47% of subjects were female and 54% of subjects were Caucasian, 22% were Black and 19% were Hispanic. The immune response to each of the vaccine antigens was assessed, 21 days after vaccination.
The immune response of Flucelvax Quad was non-inferior to TIVc for all 4 influenza strains (GMT and differences in vaccine group seroconversion rates). The antibody response to influenza B strains contained in Flucelvax Quad was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage. There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.
The non-inferiority data observed are summarised in Table 4 in children and adolescents aged 4 to less than 18 years. Flucelvax Quad is indicated for use in adults and children 9 years of age and older (see Section 4.1 Therapeutic Indications).
The immunogenicity data in subjects 9 to less than 18 years of age are summarised in Table 5.

Efficacy of trivalent influenza vaccine.

The efficacy experience with trivalent influenza vaccine (TIVc) is relevant to Flucelvax Quad because both vaccines are manufactured using the same process and have overlapping compositions.

Efficacy against culture-confirmed influenza.

A multinational (US, Finland and Poland), randomised, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of TIVc during the 2007-2008 influenza season in adults aged 18 to 49 years (NCT00630331, see http://clinicaltrials.gov). A total of 11,404 subjects were enrolled to receive TIVc (N=3828), Agrippal (N=3676) or placebo (N=3900) in a 1:1:1 ratio. Among the overall study population enrolled, the mean age was 33 years, 55% were female, 84% were Caucasian, 7% were Black, 7% were Hispanic, and 2% were of other ethnic origin.
TIVc efficacy was defined as the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine compared to placebo. Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI). ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e. a fever (oral temperature ≥ 100.0°F/ 38°C) and cough or sore throat. After an episode of ILI, nose and throat swab samples were collected for analysis. Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were calculated (Table 6).

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

Flucelvax Quad has not been evaluated for genotoxic potential.

Carcinogenicity.

Flucelvax Quad has not been evaluated for carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 0.5 mL dose of Flucelvax Quad contains the following excipients, see Table 7.
Flucelvax Quad does not contain preservative or antibiotics.

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.) Discard if the vaccine has been frozen. Protect from light.

6.5 Nature and Contents of Container

Not all presentations or pack sizes may be marketed.

AUST R 319093.

Flucelvax Quad (Influenza virus haemagglutinin) Suspension for Injection needle-free (AUST R 319093) is a 0.5 mL suspension for injection in a needle-free pre-filled Type 1 glass syringe. The syringe and all associated syringe components do not contain natural rubber latex.
Pack sizes: 1's, 10's.

AUST R 341450.

Flucelvax Quad (Influenza virus haemagglutinin) Suspension for Injection (AUST R 341450) is a 0.5 mL suspension for injection pre-filled Type 1 glass syringe with attached needle. The sheath covering the needle may contain natural rubber latex (see Section 4.4 Special Warnings and Precautions for Use).
Pack sizes: 1's, 10's.

6.6 Special Precautions for Disposal

Any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes