Consumer medicine information

Fluarix Tetra

Influenza virus vaccine, split virion, quadrivalent (inactivated)

BRAND INFORMATION

Brand name

Fluarix Tetra

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

SUMMARY CMI

FLUARIX TETRA

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 or pharmacist.

1. Why am I receiving FLUARIX TETRA?

FLUARIX TETRA contains inactivated influenza virus as the active ingredient. FLUARIX TETRA is used to vaccinate against some strains of the influenza virus.

For more information, see Section 1. Why am I receiving FLUARIX TETRA? in the full CMI.

2. What should I know before I receive FLUARIX TETRA?

Do not use if you have ever had an allergic reaction to FLUARIX TETRA, any other influenza vaccine or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you 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 I receive FLUARIX TETRA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FLUARIX TETRA 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 FLUARIX TETRA given?

Your doctor, nurse or pharmacist will give you FLUARIX TETRA as an injection into your upper arm or upper thigh muscle.
For adults and older children: FLUARIX TETRA is generally given as a single injection.
For children aged between 6 months and 9 years of age who have not received an influenza vaccine before: a second dose is given 4 weeks after the first dose.

More instructions can be found in Section 4. How is FLUARIX TETRA given? in the full CMI.

5. What should I know after receiving FLUARIX TETRA?

Driving or using machines	Be careful before you drive or use any machines or tools until you know how FLUARIX TETRA affects you. FLUARIX TETRA may cause dizziness or light-headedness in some people.
Looking after your medicine	FLUARIX TETRA will normally be stored at the doctor's surgery or in the pharmacy. If you need to store FLUARIX TETRA, keep it in the refrigerator between 2°C and 8°C. Do not freeze.

For more information, see Section 5. What should I know after receiving FLUARIX TETRA? in the full CMI.

6. Are there any side effects?

Side effects which have been reported following administration of FLUARIX TETRA include redness, swelling, a hard lump, soreness, bruising or itching around the injection site, pain at the injection site, fever, chills, shivering, sweating, dizziness, headache, a general feeling of being unwell, muscle aches and pain, joint pain, a loss of appetite, feeling sick, vomiting, diarrhoea, stomach pain, irritability, drowsiness, fatigue and rash.

Allergic reactions have also occurred following administration of FLUARIX TETRA. Allergy is rare and severe reactions will usually occur within the first few hours of vaccination. If this occurs go to the Emergency Department of the nearest ho spital immediately.

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.

FULL CMI

FLUARIX TETRA

Active ingredient(s): inactivated split influenza vaccine

Consumer Medicine Information (CMI)

This leaflet provides important information about using FLUARIX TETRA. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FLUARIX TETRA.

Where to find information in this leaflet:

1. Why am I receiving FLUARIX TETRA?
2. What should I know before I receive FLUARIX TETRA?
3. What if I am taking other medicines?
4. How is FLUARIX TETRA given?
5. What should I know after receiving FLUARIX TETRA?
6. Are there any side effects?
7. Product details

1. Why am I receiving FLUARIX TETRA?

FLUARIX TETRA contains inactivated split influenza virus as the active ingredient.

FLUARIX TETRA is used to help prevent certain types of influenza.

The vaccine works by causing the body to produce its own protection (antibodies) against four different types of influenza virus.

The types of influenza antigen contained in FLUARIX TETRA may change from one year to another. Each year the Australian Influenza Vaccine Committee (AIVC) recommends which strains to include in the vaccine. This decision is based on the types of influenza virus thought most likely to occur during the next flu season.

Therefore, it is recommended to receive an influenza vaccination every year.

FLUARIX TETRA will only protect you against the four types of influenza virus used to make the vaccine. It will not protect you from influenza caused by other types of influenza virus or from infections with other agents that cause flu-like symptoms (such as the common cold).

FLUARIX TETRA cannot give you influenza when you receive it as the virus in the vaccine has been killed.

Influenza is an infectious illness and is spread by small droplets from the nose, throat or mouth of an infected person. The most common symptoms of influenza include fever, sore throat, runny nose, coughing, general aches and pains, headache, weakness and tiredness. Most people recover completely within one week.

The risk of serious complications (e.g. pneumonia and death) is greater in very young, very old and chronically ill people.

FLUARIX TETRA can be used in adults and children older than 6 months of age.

2. What should I know before I receive FLUARIX TETRA?

Warnings

Do not receive FLUARIX TETRA if:

you are allergic to FLUARIX TETRA, any other influenza vaccine, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you or your child have a severe infection with a high temperature. Your doctor may decide to delay vaccination with FLUARIX TETRA until the illness has passed. A minor infection such as a cold is not usually a reason to delay vaccination but talk to your doctor, nurse or pharmacist about this before being vaccinated.

If you are unwell and cannot receive FLUARIX TETRA, talk to your doctor, nurse or pharmacist about when you can receive it.

Check with your doctor if you/your child:

have any other medical conditions
have an immune deficiency condition
have a bleeding disorder
take any medicines for any other condition
have had or have Guillain-Barre Syndrome, an inflammatory illness affecting the nerves and resulting in muscle weakness
have received another vaccine
are allergic to latex

You 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, nurse or pharmacist if you are pregnant or intend to become pregnant. They will discuss with you the risks and benefits involved in receiving FLUARIX TETRA.

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

It is not expected that FLUARIX TETRA will cause problems for breastfed babies.

Fainting

Fainting can occur following, or even before, any needle injection. Tell the person giving you your injection if you or your child have ever fainted with a previous injection.

3. What if I am taking other medicines?

Tell your doctor, nurse or pharmacist if you 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 FLUARIX TETRA and affect how it works.

theophylline – a medicine used in chronic obstructive pulmonary disease and asthma
phenytoin, phenobarbitone, carbamazepine – medicines used in the treatment of seizures, fits and epilepsy
warfarin – a medicine used to thin your blood to prevent blood clots
steroids, ciclosporin – medicines used to suppress the immune system

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FLUARIX TETRA.

4. How is FLUARIX TETRA given?

How much is given

Your doctor, nurse or pharmacist will give you FLUARIX TETRA as an injection
For adults and children over the age of 6 months, 0.5 mL is given

How it is given

FLUARIX TETRA is generally injected into the upper arm or upper thigh muscle

When is it given

For adults and older children: FLUARIX TETRA is generally given as a single dose each year before the start of the influenza season which usually occurs during winter
For children aged between 6 months and 9 years of age who have not received an influenza vaccine before: a second dose is given 4 weeks after the first dose

If a scheduled dose is missed, talk to your doctor or nurse and arrange another visit as soon as possible.

Vaccination against influenza should be repeated every year as different types of influenza virus strains can occur in different years.

If you are given too much FLUARIX TETRA

If you think that you have been given too much FLUARIX TETRA, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know after receiving FLUARIX TETRA?

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FLUARIX TETRA affects you.

FLUARIX TETRA may cause dizziness or light-headedness in some people.

Looking after your medicine

FLUARIX TETRA will usually be stored at the doctor's clinic or at the pharmacy.
If you need to store FLUARIX TETRA it is important to keep it in the refrigerator between 2°C and 8°C.
DO NOT FREEZE FLUARIX TETRA. FREEZING THIS MEDICINE WILL DESTROY THE VACCINE.

Follow the instructions on the carton on how to take care of your medicine properly.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you 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 or pharmacist if you have any further questions about side effects.

Most side effects with FLUARIX TETRA are mild and usually clear up within a few days. These effects, as with other vaccines, usually occur around the injection site.

Less serious side effects

Less serious side effects	What to do
redness, swelling, a hard lump, soreness, bruising or itching around the injection site pain at the injection site fever, chills, shivering, sweating, dizziness, headache, malaise (generally feeling unwell) muscle aches and pain joint pain loss of appetite, feeling sick, vomiting, diarrhoea, stomach pain irritability drowsiness fatigue rash	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

transient swollen glands in the neck, armpit or groin
painful swelling in the arms or legs
vomiting
flu-like symptoms such as a high temperature, sore throat, runny nose, cough and chills
weakness of muscles

In very young children, high fevers may result in convulsions (fits). It is advisable to monitor young children for high fevers post influenza vaccination.

There have been rare reports of Guillain-Barre Syndrome (an inflammatory illness affecting nerves and resulting in muscle weakness). However these events have not been definitively linked to the use of influenza vaccines.

allergic reaction

Signs of an allergic reaction include:
swelling of the limbs, face, eyes, inside of the nose, mouth or throat
shortness of breath, breathing or swallowing difficulties
hives, itching (especially of the hands or feet), reddening of the skin (especially around the ears) or severe skin reactions
unusual tiredness or weakness that is sudden and severe
Allergy to FLUARIX TETRA is rare. Severe reactions will usually occur within the first few hours of vaccination. If this occurs go to the Emergency Department of the nearest hospital immediately.

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

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you 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 medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What FLUARIX TETRA contains

Active ingredient (main ingredient)	A/ Victoria/4897/2022 (H1N1)pdm09-like strain A/ Thailand/8/2022 (H3N2)-like strain B/Austria/1359417/2021-like strain B/Phuket/3073/2013-like strain
Other ingredients (inactive ingredients)	dibasic sodium phosphate dodecahydrate dl-alpha-tocopheryl acid succinate formaldehyde (≤ 5 micrograms) gentamicin sulphate (trace amount) hydrocortisone (trace amount) magnesium chloride hexahydrate monobasic potassium phosphate octoxinol 10 ovalbumin (≤ 0.05 micrograms) polysorbate 80 potassium chloride sodium chloride sodium deoxycholate (trace amount) water for injections

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

FLUARIX TETRA is not made with any human blood, blood products or substances made of human origin.

Do not take this medicine if you are allergic to any of these ingredients.

What FLUARIX TETRA looks like

FLUARIX TETRA is a colourless to slightly opalescent suspension.

AUST R 200674 – pre-filled syringes available in packs of either 1 or 10 syringes without needles.

AUST R 242512 – pre-filled syringes available in packs of either 1 or 10 syringes without needles.

Not all presentations and pack sizes may be distributed.

Who distributes FLUARIX TETRA

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067

Trade marks are owned by or licensed to the GSK group of companies.

This leaflet was prepared on 22 November 2023.

Version 12.0

Published by MIMS February 2024

BRAND INFORMATION

Brand name

Fluarix Tetra

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

1 Name of Medicine

Quadrivalent influenza vaccine (split virion, inactivated).

2 Qualitative and Quantitative Composition

Fluarix Tetra is an inactivated and purified split influenza vaccine. The antigen composition and strains for the 2024 influenza season corresponds to the following types:
A/Victoria/4897/2022 (H1N1)pdm09-like strain;
A/Thailand/8/2022 (H3N2)-like strain;
B/Austria/1359417/2021-like strain;
B/Phuket/3073/2013-like strain.
Fluarix Tetra is prepared using whole virus cultivated in embryonated hens' eggs. The virus is concentrated and purified by clarification, adsorption and centrifugation. The purified whole virus is then treated with the detergent sodium deoxycholate and again centrifuged, and the resulting antigen suspension is inactivated with formaldehyde.
Each 0.5 mL vaccine dose contains 15 microgram haemagglutinin of each of four influenza strains in phosphate buffered saline.
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
Fluarix Tetra meets the WHO requirements for biological substances and influenza vaccines and the European Pharmacopoeia requirements for influenza vaccines.
The type and amount of viral antigens in Fluarix Tetra conform to the annual requirements of the Australian Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.
Fluarix Tetra is a colourless to slightly opalescent suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Fluarix Tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the influenza virus types A and B contained in the vaccine (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
The use of Fluarix Tetra should be based on official recommendations.

4.2 Dose and Method of Administration

Fluarix Tetra should under no circumstances be administered intravascularly.

Children aged < 6 months.

The safety and efficacy of Fluarix Tetra in children aged less than 6 months have not been established.

Dosage.

Fluarix Tetra should be administered as a single 0.5 mL injection.
Children 6 months to less than 9 years of age who have not previously been vaccinated against influenza should receive a second dose of 0.5 mL after an interval of at least 4 weeks.

Administration.

Vaccination should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).

4.3 Contraindications

Fluarix Tetra should not be administered to individuals with known hypersensitivity after previous administration of Fluarix Tetra or influenza vaccines or to any component of the vaccine.

4.4 Special Warnings and Precautions for Use

Fluarix Tetra should under no circumstances be administered intravascularly.
It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
As with other vaccines, vaccination with Fluarix Tetra should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.
Fluarix Tetra is not effective against all possible strains of influenza virus. Fluarix Tetra is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains.
Patients with a history of Guillain-Barré syndrome (GBS) with an onset within six weeks of an influenza vaccination may be at increased risk of again developing GBS if given influenza vaccine. Such risk should be weighed against the benefits to the individual patient of influenza vaccination.
As patients with a history of GBS have an increased likelihood of again developing the syndrome, the chance of them coincidently developing the syndrome following influenza vaccination may be higher than in individuals with no history of GBS.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
As with other vaccines administered intramuscularly, Fluarix Tetra should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these individuals.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.

Latex.

Prefilled syringe with attached needle.

This presentation of Fluarix Tetra cannot be considered latex-free. The removable needle shield contains natural rubber latex.

Prefilled syringe with separate needle.

The syringe cap, syringe plunger and needle protector of the prefilled syringes of Fluarix Tetra with separate needles are not made with natural rubber latex.

Use in the elderly.

Antibody responses were lower in older adults who received Fluarix Tetra than in younger subjects. In a randomized, double-blind (2 arms) and open-label (one arm), active-controlled study, immunogenicity and safety were evaluated in a cohort of subjects 65 years of age and older who received Fluarix Tetra (N = 1,517); 469 of these subjects were 75 years of age and older. In subjects 65 years of age and older, the geometric mean antibody titers post-vaccination and seroconversion rates were lower than in younger subjects (18 through 64 years of age) and the frequencies of solicited and unsolicited adverse events were generally lower than in younger subjects.

Paediatric use.

See Section 4.4 Special Warnings and Precautions for Use.

Effects on laboratory tests.

False positive ELISA serologic tests for HIV-1, Hepatitis C, and especially HTLV-1 may occur following influenza vaccination. These transient false-positive results may be due to cross-reactive IgM elicited by the vaccine. For this reason, a definitive diagnosis of HIV-1, Hepatitis C, or HTLV-1 infection requires a positive result from a virus-specific confirmatory test (e.g. Western Blot or immunoblot).

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed. If Fluarix Tetra is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
Influenza vaccine can impair the metabolism of warfarin, theophylline, phenytoin, phenobarbitone and carbamazepine by the hepatic cytochrome P450 system. Results from studies have been variable in degree of interaction and time after vaccination for the interaction to take effect. The interaction may be variable from individual to individual. Patients taking warfarin, theophylline, phenytoin, phenobarbitone or carbamazepine should be advised of the possibility of an interaction and told to look out for signs of elevated levels of their medication.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

A reproductive and developmental toxicity study in which female rats were administered Fluarix Tetra (0.2 mL dose per rat, approximately 80x the human dose on the basis of bodyweight) twice prior to mating showed no adverse effects on female fertility.
(Category A)
A developmental and reproductive toxicity study has been performed in which female rats were administered Fluarix Tetra by IM injection (0.2 mL dose per rat, approximately 80x the human dose on the basis of bodyweight) twice prior to mating, four times during gestation, and once on lactation day 7. Exposure to Fluarix Tetra did not result in systemic maternal toxicity (no adverse clinical signs and no change in body weight or food consumption). In addition, no adverse effects on pregnancy, parturition, lactation, or embryo-foetal or pre-weaning development were observed. There were no vaccine-related foetal malformations or other evidence of teratogenesis noted in this study.
The Australian Department of Health has reviewed the considerable extent of immunisation of pregnant Australian women with inactivated influenza vaccines, the international published literature, the very limited reporting of possible adverse effects and the studies conducted by vaccine manufacturers and concluded that there is no increased risk of any adverse foetal or maternal outcomes attributable to the vaccine. Fluarix Tetra can be given to a pregnant woman following an assessment of the risks and benefits. Because of the known adverse consequences of influenza infection in pregnant women, Australian health authorities recommend vaccination of pregnant women.
The safety of Fluarix Tetra when administered to breastfeeding women has not been evaluated. It is unknown whether Fluarix Tetra is excreted in human breast milk.
Vaccine antigen specific antibodies were transferred to rat pups via milk from dams administered Fluarix Tetra during gestation and lactation, with no adverse effects.
Fluarix Tetra should only be used during breastfeeding when the possible advantages outweigh the potential risks.

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 trial data.

Adverse reactions reported for Fluarix Tetra in the different age groups are listed according to the following frequency categories: Very common ≥ 1/10, Common ≥ 1/100 to < 1/10, Uncommon ≥ 1/1,000 to < 1/100, Rare ≥ 1/10,000 to < 1/1,000 and Very rare < 1/10,000.

Adults.

A clinical study with Fluarix Tetra in adults has evaluated the incidence of adverse reactions in subjects ≥ 18 years who received one dose of Fluarix Tetra (N = 3,036) or Fluarix (N = 1,010).
The following adverse reactions per dose have been reported (see Table 1):

Children aged 6 months to < 18 years.

Two clinical studies evaluated the reactogenicity and safety of Fluarix Tetra in children who received at least one dose of Fluarix Tetra or a control vaccine.
One study enrolled children 3 to < 18 years of age who received Fluarix Tetra (N = 915) or Fluarix (N = 912). The second study enrolled children 6 to < 36 months of age who received Fluarix Tetra (N = 6,006) or a non-influenza vaccine control (N = 6,012) (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
The following adverse reactions per dose have been reported (see Table 2):

Table 3 shows the incidence of solicited local and systemic adverse reactions overall/dose within 7 days^a after vaccination in children aged 6 through 35 months^b (Total Vaccinated Cohort):

Post-marketing data.

Post-marketing experience with Fluarix and Fluarix Tetra, which are both manufactured according to the same antigen production and formulation process and are essentially similar other than Fluarix lacking a second B-strain, identified the following adverse reactions¹ (see Table 4).

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.

4.9 Overdose

Insufficient data are available.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
Fluarix Tetra provides active immunisation against the four influenza virus strains (two A subtypes and two B strains) contained in the vaccine. Fluarix Tetra induces humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses.
Specific levels of haemagglutination-inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HI antibody titers have been used as a measure of vaccine activity. In some human challenge studies, HI antibody titres of ≥ 1:40 have been associated with protection from influenza illness in up to 50% of individuals.
Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination, and because circulating strains of influenza virus might change from year to year. Protection afforded as a result of vaccination with Fluarix Tetra is specific to the influenza strains contained in Fluarix Tetra or to closely related strains.

Clinical trials.

Efficacy in children 6-35 months of age.

The efficacy of Fluarix Tetra was evaluated in clinical study D-QIV-004, a randomised, observer-blind, non-influenza vaccine-controlled trial conducted during influenza seasons 2011 to 2014. Healthy subjects aged 6 through 35 months were randomized (1:1) to receive Fluarix Tetra (N = 6,006) or a non-influenza control vaccine (N = 6,012). They were administered 1 dose (in case of history of influenza vaccination) or 2 doses, approximately 28 days apart.
Efficacy of Fluarix Tetra was assessed for the prevention of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B disease (moderate to severe and of any severity) due to any seasonal influenza strain. Starting 2 weeks post-vaccination until the end of the influenza season (approximately 6 months later), nasal swabs were collected following an influenza like event, and tested for influenza A and/or B by RT-PCR. All RT-PCR-positive specimens were further tested for viability in cell culture and to determine whether the viral strains matched those in the vaccine.
Fluarix Tetra met the predefined criteria for primary and secondary vaccine efficacy objectives presented in Table 5.

Exploratory analyses were conducted on the Total Vaccinated Cohort including 12,018 subjects (N = 6,006 for Fluarix Tetra, N = 6,012 for control). Fluarix Tetra was efficacious in the prevention of moderate to severe influenza caused by each of the 4 strains (Table 6), even when there was significant antigenic mismatch with 2 of the vaccine strains (A/H3N2 and B/Victoria).

Additionally, for RT-PCR confirmed cases of any severity, Fluarix Tetra reduced the risk of visits to the general practitioner by 47% (Relative Risk (RR): 0.53 [95% CI: 0.46; 0.61], i.e. 310 versus 583 visits) and to the emergency room by 79% (RR: 0.21 [95% CI: 0.09; 0.47], i.e. 7 versus 33 visits). The use of antibiotics was reduced by 50% (RR: 0.50 [95% CI: 0.42; 0.60], i.e. 172 versus 341 subjects).

Immunogenicity in children and adults.

Immunogenicity of Fluarix Tetra was evaluated in terms of HI Geometric mean antibody titer (GMT) at 28 days after the last dose (children) or Day 21 (adults) and HI seroconversion rate (4-fold rise in reciprocal titer or change from undetectable [< 10] to a reciprocal titer of ≥ 40).
In study D-QIV-004 (children 6-35 months), the evaluation was performed in a sub-cohort of 1,332 children (753 in the Fluarix Tetra group and 579 in the control group). The results are presented in Table 7.
The effect of a 2-dose priming schedule in D-QIV-004 was evaluated by assessing the immune response after revaccination one year later with 1 dose of Fluarix Tetra in study D-QIV-009. This study demonstrated that 7 days post-vaccination, immune memory in children 6 to 35 months of age had been elicited for all four vaccine strains.
Immunogenic non-inferiority of Fluarix Tetra was assessed versus Fluarix in children in study D-QIV-003 (approximately 900 children 3 to < 18 years of age in each treatment group who received one or two doses of either vaccine) and adults in study D-QIV-008 (approximately 1,800 subjects 18 years of age and older received 1 dose of Fluarix Tetra and approximately 600 subjects received 1 dose of Fluarix). In both studies, Fluarix Tetra elicited an immune response against the three strains in common that was non-inferior to Fluarix and a superior immune response against the additional B strain included in Fluarix Tetra. The results are presented in Table 7.

5.2 Pharmacokinetic Properties

Absorption.

Not applicable.

Distribution.

Not applicable.

Metabolism.

Not applicable.

Excretion.

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

Fluarix Tetra has not been tested for genotoxic potential.

Carcinogenicity.

Fluarix Tetra has not been tested for carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

The vaccine preparation also contains polysorbate 80, octoxinol 10, dl-alpha-tocopheryl acid succinate, sodium chloride, dibasic sodium phosphate dodecahydrate, monobasic potassium phosphate, potassium chloride, magnesium chloride hexahydrate, water for injections.
Residual amounts of ovalbumin ≤ 0.05 microgram and formaldehyde ≤ 5 microgram, but also traces of gentamicin sulphate, hydrocortisone, and sodium deoxycholate from the manufacturing process may be present.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

The shelf life of Fluarix Tetra is a maximum of 15 months from the date of manufacture if stored between temperatures of +2°C and +8°C.
The expiry date of the vaccine is indicated on the label and packaging.

6.4 Special Precautions for Storage

Fluarix Tetra must be stored between +2°C and +8°C and be protected from light.
Do not freeze. Discard if vaccine has been frozen.

6.5 Nature and Contents of Container

Fluarix Tetra is presented in pre-filled syringes as pack sizes of 1 or 10.
The pre-filled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia requirements.
Not all pack sizes may be distributed in Australia.
Fluarix Tetra inactivated split influenza vaccine suspension for injection 0.5 mL pre-filled PRTC syringe without needle [AUST R 242512].
Fluarix Tetra inactivated split influenza vaccine suspension for injection 0.5 mL pre-filled syringe without needle [AUST R 200674]*.
* Not currently supplied.

6.6 Special Precautions for Disposal

Instructions for use and handling.

The vaccine presents as a colourless to slightly opalescent suspension.
The syringe should be shaken and inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.

Instructions for use and handling of the vaccine presented in prefilled syringe with separate needle.

To attach the needle to the syringe, refer to the pictures provided in the patient information insert.
1. Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
2. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock (see picture).
3. Remove the needle protector, which on occasion can be a little stiff.
4. Administer the vaccine.
Any unused product of waste material should be disposed of in accordance with local requirements.
Fluarix Tetra is for single use in one patient only.

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Fluarix Tetra

Influenza virus vaccine, split virion, quadrivalent (inactivated)

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