Consumer medicine information

Fluad Quad

Influenza virus geriatric vaccine, surface antigen, quadrivalent (inactivated)

BRAND INFORMATION

Brand name

Fluad Quad

Active ingredient

Influenza virus geriatric vaccine, surface antigen, quadrivalent (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions about Fluad® 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 Fluad® Quad against the benefits they expect it will have for you.

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

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

What Fluad® Quad is used for

Fluad® Quad is a vaccine used to help prevent certain types of influenza or “flu”. It is for use in people aged 65 years and older only.

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 adults 65 years of age and older and 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

Fluad® Quad works by causing your body to produce its own protection against the four types of influenza virus that are in the vaccine. 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, Fluad® Quad may be changed to contain fragments of the new types of virus. Therefore, vaccination is required yearly.

Please note that an influenza vaccine will only protect you against the types of influenza virus used to make it. 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 influenza. However, as with all vaccines, 100% protection cannot be guaranteed.

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

Before you are given Fluad® Quad

When you must not be given it

Do not have Fluad® Quad if you have severe allergy to:

  • any of the ingredients listed at the end of this leaflet
  • any other influenza vaccines

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

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 Fluad® Quad if you are under 65. Fluad® Quad is for use in persons 65 years and older only.

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

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

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

Before you are given Fluad® Quad

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

  • severe allergic reaction (anaphylaxis)
  • difficulty breathing
  • swelling of the throat
  • fainting or collapse
  • fits or convulsions
  • high temperature (greater than 40°C)
  • severe skin reaction at the injection site, including severe bruising

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

  • Guillain-Barré Syndrome (an 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 have allergies to:

  • any other medicines
  • eggs or egg proteins
  • any other substances, such as latex, foods, preservatives or dyes

Your doctor will decide if you can receive Fluad® Quad.

Taking other medicines

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

Some medicines and Fluad® Quad may interfere with each other and may affect how well the vaccine works. These include 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 adjustment of your medication is necessary.

Having other vaccines

Tell your doctor if you have had any vaccines in the last 4 weeks. Fluad® 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 Fluad® Quad.

How Fluad® Quad is given

Fluad® Quad is given as an injection, usually into your shoulder muscle by a doctor, nurse or pharmacist.

How much is given

A single 0.5 mL dose.

When it is given

Fluad® 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 Fluad® Quad

Things you must do

Keep an updated record of your 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 Fluad® 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 Fluad® Quad affects you. Fluad® Quad should not normally interfere with your ability to drive or operate machinery. However, it may cause dizziness, light-headedness or tiredness in some people.

Side effects

Tell your doctor or pharmacist as soon as possible, if you do not feel well after having Fluad® Quad.

Fluad® 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 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 notice any of the following and they worry you:

  • local reaction around the injection site such as redness, tenderness, pain, warmth, burning or stinging, swelling or the formation of hard lumps, and bruising
  • fatigue
  • headache
  • soreness, aching muscles or joints, muscle tenderness or weakness (not caused by exercise)
  • diarrhoea
  • chills
  • nausea
  • loss of appetite
  • vomiting
  • fever

These are the more common side effects of Fluad® Quad. Mostly these are mild and usually disappear within 3 days without treatment.

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

  • abscess at the injection site
  • skin rash, itchy spots or red lumps on the skin
  • tingling
  • swollen lymph nodes

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

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
  • shortness of breath, wheezing or trouble breathing
  • rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting (shock)
  • fits or convulsions
  • muscular weakness
  • passing little or no urine
  • headache and high temperature associated with hallucinations, confusion, paralysis of part or all of the body, disturbances of behaviour, speech and eye movements, stiff neck and sensitivity to light
  • bleeding or bruising more easily than normal
  • stabbing or throbbing nerve pain

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.

These are very serious side effects. You may need urgent medical attention or hospitalisation. 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 feel unwell.

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

Storing Fluad® Quad

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

  • Keep it where children cannot reach it.
  • Keep Fluad® 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 Fluad® Quad. Discard if the vaccine has been frozen.
    Freezing destroys the vaccine

Product description

What it looks like

Fluad® Quad is a milky-white liquid in a pre-filled syringe.

Ingredients

  • Active ingredients:
    Each 0.5 mL contains 15 micrograms of influenza virus fragments (influenza virus haemagglutinin) from each of the following types of influenza virus:
    - A/Victoria/2570/2019 (H1N1)pdm09-like strain
    - A/Hong Kong/2671/2019 (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 winter.
  • Other ingredients
    Adjuvant: MF59C.1: containing squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid monohydrate, water for injections.
    Other: sodium chloride, potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injections.

Fluad® Quad may also contain traces of kanamycin sulfate, neomycin sulfate, egg proteins (ovalbumin), formaldehyde, cetrimonium bromide, sucrose, and hydrocortisone as residues of the manufacturing process.

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

Manufacturer/Distributor/ Supplier

Fluad® Quad sponsored by:

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

AUST R313724

AUST R 316323

Date of Revision:

15 October 2020

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

Published by MIMS March 2021

BRAND INFORMATION

Brand name

Fluad Quad

Active ingredient

Influenza virus geriatric vaccine, surface antigen, quadrivalent (inactivated)

Schedule

S4

 

1 Name of Medicine

Fluad Quad.

Inactivated quadrivalent influenza vaccine (surface antigen), adjuvanted, suspension for injection; containing Influenza virus haemagglutinin as active ingredient.

2 Qualitative and Quantitative Composition

Each 0.5 mL dose contains influenza virus surface antigens (haemagglutinin and neuraminidase) of each of four antigens representative of the influenza virus types expected to circulate in the Southern Hemisphere winter according to WHO recommendations for the 2021 season.
A/Victoria/2570/2019 (H1N1)pdm09-like virus (A/Victoria/2570/2019 IVR-215): 15 microgram HA* per dose.
A/Hong Kong/2671/2019 (H3N2)-like virus (A/Hong Kong/2671/2019 IVR-208): 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.
Fluad Quad vaccine is prepared from virus grown in embryonated hens' eggs and inactivated with formaldehyde before purification and combination with MF59C.1, an adjuvant known to increase the immunogenicity of vaccines. MF59C.1 adjuvant is a squalene based oil-in-water emulsion. Squalene is a normal component in the human body and is easily metabolized and excreted. For a full list of excipients, see Section 6.1 List of Excipients.
The type and amount of viral antigens in Fluad Quad conform to the requirements of the Australian Influenza Vaccine Committee for the 2021 Southern Hemisphere Influenza season. The strains chosen for vaccine manufacture are endorsed by the Australian Influenza Vaccine Committee as being antigenically equivalent to the reference virus.
Fluad Quad is manufactured in eggs and trace amounts of kanamycin sulfate, neomycin sulfate, ovalbumin (≤ 1 microgram/0.5 mL dose), formaldehyde (≤ 1 microgram/0.5 mL dose), cetrimonium bromide (≤ 18 microgram/0.5 mL dose), sucrose and hydrocortisone may be present as residues of the manufacturing process.

3 Pharmaceutical Form

Fluad Quad is a milky-white suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Active immunisation against influenza in persons 65 years of age and older.

4.2 Dose and Method of Administration

Fluad Quad is for use in adults 65 years of age and older only. See Section 4.1 Therapeutic Indications.
A single 0.5 mL dose should be administered by intramuscular injection, preferably into the deltoid muscle of the upper arm.
Gently shake before use. After shaking, the normal appearance of the vaccine is a milky-white 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.
Fluad Quad contains no antimicrobial preservative. Use in one patient on one occasion only. Discard any residue.
Annual revaccination is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus change from year to year.
Persons with a history of egg allergy (non-anaphylaxis) can receive a full dose of vaccine in any immunisation setting (also see Section 4.4 Special Warnings and Precautions for Use).

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 6.1 List of Excipients), except egg proteins (also see Section 4.4 Special Warnings and Precautions for Use); 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 an anaphylactic event occurs following the 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.
Immunisation should be postponed in patients with acute febrile illness until the fever is resolved.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
A protective 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 Fluad Quad should be based on careful consideration of the potential benefits and risks.
The syringe and all associated syringe components for Fluad Quad AUST R 313724 pre-filled syringe needle-free do not contain natural rubber latex. Fluad Quad AUST R 316323 pre-filled syringe with attached needle cannot be considered to be latex-free as the sheath covering the needle contains natural rubber latex. See Section 6.5 Nature and Contents of Container for further information.

Use in the elderly.

Fluad Quad is approved for active immunisation against influenza in persons 65 years of age and older. See Section 4.1 Therapeutic Indications; Section 5 Pharmacological Properties.

Paediatric use.

Paediatric data have not been evaluated.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No clinical data on concomitant administration of Fluad Quad with other vaccines are available.
Data from two studies on the concomitant administration of Fluad (inactivated, trivalent influenza vaccine (surface antigen), adjuvanted, suspension for injection) with an approved 13-valent pneumococcal conjugate vaccine (PCV13) and an approved 23-valent pneumococcal polysaccharide vaccine (PPSV23) in an elderly population are available. These studies indicated that coadministration of Fluad with either PCV-13 or PPSV23 did not show significant interference in antibody response. Although concomitant vaccination induced more frequent local pain, most of the local adverse reactions were mild. Systemic adverse reactions were generally mild, and no serious vaccine-related adverse events occurred.
If Fluad Quad needs to be used at the same time as another vaccine, immunisation should be given at separate injection sites, preferably on different limbs. It should be noted that the adverse reactions may be intensified.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Animal reproduction studies have not been conducted with Fluad Quad. In a reproductive and developmental study in rabbits dosed with the trivalent vaccine Fluad (AUST R 90339 and AUST R 306718) twice pre-mating (21 and 7 days before mating) and during gestation (gestation day 7 and 20), there were no significant effects on the does, their fetuses or pups. The HA dose in rabbits was approximately 11-times the recommended clinical dose of a HA dose per body weight basis. Circulating anti-H1N1 antibodies were detected in the does, fetuses and pups.
There are no adequate and well-controlled studies in pregnant women. Fluad Quad is indicated for persons 65 years and over.
No data available.

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)

The overall safety profile of Fluad Quad is similar to the adjuvanted trivalent influenza vaccine, Fluad.

Clinical trials.

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.
The safety of a single dose of Fluad Quad in subjects 65 years of age and older was evaluated in clinical study V118_20. See Section 5.1 Pharmacodynamic Properties for further detail.
In study V118_20, adverse events were collected as either solicited or unsolicited AEs. Solicited local and systemic events were collected for 7 days after vaccination (Table 1). Unsolicited AEs were collected for 21 days following vaccination, and for the full duration of study participation for serious AEs (SAEs), AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), AEs of special interest (AESIs).
In the study, 51.8% of subjects reported any solicited AE after Fluad Quad vaccination, compared with 48.7%, and 48.2% in the Fluad and aTIV-2 groups respectively. The most commonly reported (≥ 10%) solicited AEs were injection site pain (31.9%), fatigue (16%) and headache (12.0%) (see Table 1). The majority of the adverse events reported were mild or moderate in intensity and resolved within 3 days. Solicited AEs with severe intensity were uncommon in all study groups.
Overall, the solicited AEs show that the safety profile of Fluad Quad in subjects 65 years of age and older was generally similar compared to the aTIV comparators.
Unsolicited adverse events (AEs) were collected for 21 days after vaccination. The frequency of unsolicited AEs was similar between the different vaccination groups, Fluad Quad (15.3%), Fluad (11.3%) and aTIV-2 (15.3%). Influenza-like-illness (2.0%), injection site bruising (1.1%) and cough (1.0%) were reported in ≥ 1% of subjects who received Fluad Quad.
No treatment-related SAE or death were reported in the study.
Two AESIs were reported during the study: one in the Fluad group, and one in the Fluad Quad group. Neither of the AESIs was considered to be related to study vaccine.
The frequency of unsolicited events leading to NOCD was similar across study groups: Fluad Quad (2.6%); Fluad (3.6%) and aTIV-2 (3.2%). NOCDs were heterogeneous in nature and consistent with the clinical conditions spontaneously occurring in subjects 65 years of age and older. No reported NOCDs were considered related to study vaccine.
No unsolicited AEs led to withdrawal from the study.

Post-marketing surveillance.

There are currently no post-marketing data available for Fluad Quad.
However, the post-marketing experience with Fluad may be relevant to Fluad Quad because both vaccines are manufactured using the same process and have overlapping compositions. The following adverse reactions were reported from post marketing surveillance in subjects 65 years of age or older administered Fluad.
As these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.

Blood and lymphatic system disorders.

Thrombocytopenia (some very rare cases were severe with platelet counts less than 5,000 per mm3), lymphadenopathy.

General disorders and administration site conditions.

Extensive swelling of injected limb lasting more than one week, injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week).

Immune system disorders.

Allergic or immediate hypersensitivity reactions, including anaphylactic shock.

Musculoskeletal and connective tissue disorders.

Muscular weakness.

Nervous system disorders.

Encephalomyelitis, Guillain-Barré syndrome, convulsions, neuritis, neuralgia, paraesthesia,

Skin and subcutaneous tissue disorders.

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

Vascular disorders.

Vasculitis which may be associated with transient renal involvement.

Reporting of 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 via at http://www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/consumer-reporting/ (New Zealand).

4.9 Overdose

There are no data on overdose with Fluad Quad.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) and the New Zealand Poisons Centre on 0800 POISON or 0800 764766 (New Zealand.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Fluad Quad provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.
Fluad Quad has been shown to evoke antibody responses to the viral surface glycoproteins, haemagglutinin and neuraminidase. These antibodies provide protection against clinical illness in a high proportion of vaccine recipients.
The antibody response to Fluad Quad is similar to Fluad which is increased when compared to the response to vaccines without adjuvant, and is most pronounced for A/H3N2 influenza antigens. This increased response is even more pronounced in subjects 65 years of age and older. The inclusion of the second B strain in Fluad Quad also provides additional benefit compared to Fluad.
The adjuvant MF59 broadens the overall immune response allowing the vaccine to offer greater protection against heterologous strains of the virus. This may be important when there is a mismatch between the virus strains included in the vaccine and the strains circulating in the community. The antibody response is increased when compared to the response to non-adjuvanted inactivated influenza vaccine. This increased response is seen particularly in elderly subjects with low pre-immunisation titres and/or with underlying diseases (diabetes, cardiovascular and respiratory diseases) who are at increased risk of complications of influenza 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 in adults, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects.
Antibody against a specific influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to a specific antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.
The addition of the squalene-based MF59 oil-in-water emulsion adjuvant in Fluad Quad leads to enhanced antigen uptake by recruiting immune cells at the injection site and differentiating into antigen presenting cells. This results in an increased magnitude, breadth and persistence of the immune response through the duration of the influenza season compared with non-adjuvanted influenza vaccines.
Annual revaccination is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus change from year to year.

Clinical trials.

Immunogenicity.

The immunogenicity of Fluad Quad was evaluated in clinical study V118_20, a multi-centre, randomised, double-blind, non-inferiority, comparator controlled study conducted in subjects 65 years of age and older in the 2017-18 Northern Hemisphere influenza season. In this study, 888 received Fluad Quad, 444 subjects received the licensed trivalent influenza vaccine (Fluad, aTIV-1) and 444 subjects received an adjuvanted trivalent influenza vaccine containing the alternative B strain (a-TIV-2).
The per protocol immunogenicity set included a total of 1741 subjects: Fluad Quad (N = 872), Fluad (N = 436) and aTIV-2 (N = 433). In the per protocol set, the mean age of subjects at enrolment who received Fluad Quad was 72.4 years.
Non-inferiority of the immune response of Fluad Quad to that of Fluad (aTIV-1) and TIV-2 among adults 65 years of age or older was assessed as a co-primary endpoint. Adjusted HI Geometric Mean Titre (GMT) ratios and the difference in seroconversion rates for each vaccine strain were assessed 21 days after vaccination. Pre-specified non-inferiority criteria required that the upper bound of the 2-sided 95% CI of the GMT ratio (GMTaTIV/GMTFluad Quad) did not exceed 1.5 and the upper bound of the 2-sided 95% CI of the seroconversion rate difference (SCRaTIV-SCRFluad Quad) did not exceed 10% for each strain.
Fluad Quad was non-inferior for all 4 influenza strains for both HI antibody titres and seroconversion rates (Table 2).
Immunogenicity based on CBER (Center for Biologics Evaluation and Research) criteria as measured by the percentage of subjects achieving seroconversion for HI antibodies and percentage of subjects achieving an HI antibody titre ≥ 1:40 at 21 days post-vaccination was assessed as a second co-primary endpoint. Success criteria was met if the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody met or exceeded 30% and the lower limit of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titre ≥ 1:40 met and exceeded 60%.
The second co-primary objective was met for A strains (H1N1 and H3N2), but not for B strains (B Yamagata and B-Victoria). Results for B strains in the Fluad and aTIV-2 groups were similar to those obtained for Fluad Quad.
Immunological superiority of Fluad Quad compared to Fluad and aTIV-2 for the B strain that was not included in each aTIV vaccine was assessed by the GMT ratio and difference in seroconversion at 21 days post-vaccination. Superiority was met if the upper limit of the two-sided 95% CI for the GMT ratio (GMTaTIV/GMTFluad Quad) was < 1, and the upper limit of the two-sided 95% CI for the difference in SCRs (SCRaTIV-SCRFluad Quad) was < 0, for both B strains.
The pre-specified criteria for immunological superiority for the alternate B strain of Fluad Quad relative to each aTIV vaccine were met.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated-dose toxicity (60 microgram HA/dose), local tolerance and sensitization (45 microgram HA/dose). For the reproductive and development toxicity see Section 4.6 Fertility, Pregnancy and Lactation.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 0.5 mL dose of Fluad Quad contains MF59C.1 (a proprietary adjuvant): containing squalene 9.75 mg, polysorbate 80 1.175 mg, sorbitan trioleate 1.175 mg, sodium citrate dihydrate 0.66 mg, citric acid monohydrate 0.04 mg and water for injections and the following excipients. See Table 3.
Fluad Quad contains no antimicrobial preservative.

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 313724.

Fluad Quad, inactivated, quadrivalent influenza vaccine (surface antigen), adjuvanted, suspension for injection, 0.5 mL pre-filled syringe, needle-free (AUST R 313724) is a 0.5 mL suspension for injection in a needle-free pre-filled syringe (type I glass).
The syringe barrel, plunger and rubber stopper are not manufactured with natural rubber latex.
Pack sizes: 1's; 10's.

AUST R 316323.

Fluad Quad, inactivated, quadrivalent influenza vaccine (surface antigen), adjuvanted, suspension for injection, 0.5 mL pre-filled syringe, with attached needle (AUST R 316323) is a 0.5 mL suspension for injection in a pre-filled syringe (type I glass) with attached needle.
The sheath covering the needle contains natural rubber latex (see Section 4.4 Special Warnings and Precautions for Use).
The syringe barrel, plunger and rubber stopper are not manufactured with natural rubber latex.
Pack sizes: 1's; 10's.

6.6 Special Precautions for Disposal

In Australia, 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)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes