Fluzone^® High-Dose

MIMS Revision Date: 01 March 2026

1 Name of Medicine

Inactivated trivalent influenza vaccine, split virion (Influenza virus haemagglutinin).

2 Qualitative and Quantitative Composition

Fluzone High-Dose for intramuscular injection is an inactivated influenza virus vaccine. It contains 180 micrograms (microgram) influenza virus haemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 60 microgram HA of each of the three strains recommended for the 2026 influenza season:
A/Missouri/11/2025 (H1N1) pdm09-like strain (A/Switzerland/6849/2025, IVR-278);
A/Singapore/GP20238/2024 (H3N2)-like strain (A/Singapore/GP20238/2024, IVR-277);
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type).
The type and amount of viral antigens contained in Fluzone High-Dose conform to the annual requirements of the Australian Influenza Vaccine Committee (AIVC) recommendations for the season.
Fluzone High-Dose is prepared from influenza viruses propagated in embryonated chicken eggs and inactivated with formaldehyde. The influenza virus is concentrated and purified, and is then chemically disrupted to produce a "split virus". The split virus is further purified by diafiltration and diluted to appropriate concentration. Antigens from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation.
For the full list of excipients, see Section 6.1 List of Excipients.
Fluzone High-Dose is presented in prefilled syringes that are not made with natural rubber latex.

3 Pharmaceutical Form

Fluzone High-Dose suspension for injection is a colourless opalescent liquid.

4 Clinical Particulars

4.1 Therapeutic Indications

Fluzone High-Dose is indicated for active immunisation for the prevention of influenza disease. Fluzone High-Dose is indicated for use in persons 60 years of age and older.
The use of Fluzone High-Dose should be based on official recommendations.
See Section 5.1 Pharmacodynamic Properties, Clinical trials for information on the effects on influenza associated complications.

4.2 Dose and Method of Administration

Fluzone High-Dose should be given in accordance with the national recommendation as per the current Immunisation Handbook.
The recommended dosage of Fluzone High-Dose is 1 dose of 0.5 mL, annually, in persons 60 years of age and older.
Administration should be carried out by intramuscular route.
Injections of Fluzone High-Dose should be administered intramuscularly, preferably in the deltoid muscle. The vaccine should not be injected into the gluteal region, or into areas where there may be a major nerve trunk.
For needle size and length, refer to the national recommendations as per the current Immunisation Handbook.
Do not administer this product intravenously.
Shake before use to distribute suspension uniformly before administration.
Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
The syringe is for single use only and must not be reused. Discard any remaining unused contents.

4.3 Contraindications

Fluzone High-Dose is contraindicated in anyone with a history of severe allergic reaction:
after previous administration of any influenza vaccine;
to any component of the vaccine (i.e. as defined under Section 2 Qualitative and Quantitative Composition; Section 6.1 List of Excipients). See Section 4.4 Special Warnings and Precautions for Use for individuals with egg allergy;
to a vaccine containing the same components.

4.4 Special Warnings and Precautions for Use

Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.
Hypersensitivity. Prior to any vaccine injection, all known precautions should be taken to prevent hypersensitivity reactions. This includes a review of the individual's prior vaccination history with respect to possible hypersensitivity to the vaccine or similar vaccines.
Adrenaline injection (1:1000) and other appropriate agents used for the control of immediate allergic reactions must be available to treat unexpected reactions (e.g. anaphylaxis). As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in the event of severe allergic reaction/anaphylactic reaction following administration of Fluzone High-Dose.
Each dose may contain traces of formaldehyde, ovalbumin, and octoxinol-9, which are used during vaccine production. Caution should be exercised when the vaccine is administered to individuals with hypersensitivity to any components of the vaccine including manufacturing residuals.
Individuals with egg allergy of any severity may be vaccinated:
Individuals who report having had an allergic reaction to eggs involving only symptoms of urticaria (hives) may receive the vaccine;
Individuals who report having had a severe allergic reaction/anaphylaxis (e.g. angioedema, respiratory distress, light headedness, or recurrent emesis, or who required epinephrine or another emergency medical intervention) to egg should have the influenza vaccine administered in an inpatient or outpatient medical setting (including, but not necessarily limited to, hospitals, clinics, health departments, and physician offices). Vaccine administration should be supervised by a healthcare provider who is able to manage severe allergic reactions.
Refer to the current Immunisation Handbook for more information.
Neurological disorders. Recurrence of Guillain-Barre syndrome (GBS) has been temporally associated with the administration of influenza vaccine. If GBS has occurred within 6 weeks of any previous influenza vaccination, the decision to give Fluzone High-Dose should be based on careful consideration of the potential benefits and risks. Refer to the current Immunisation Handbook for more information.
Immunosuppressive treatments or conditions. The immunogenicity of Fluzone High-Dose may be reduced by immunosuppressive treatment or in individuals with immune deficiency syndromes. In such cases it is recommended to postpone the vaccination until after the immunosuppressive treatment or resolution of the immunosuppressive condition, if feasible. Vaccination of individuals with chronic immunodeficiencies is recommended even though the antibody response may be limited.
Protection. As with any vaccine, vaccination with Fluzone High-Dose may not protect 100% of recipients.
Influenza virus is remarkably unpredictable in that significant antigenic changes may occur from time to time. At this time, current influenza virus vaccines are not effective against all possible influenza strains. Protection is limited to those strains of virus from which the vaccine is prepared or to closely related strains.
Bleeding disorder. Because any intramuscular injection can cause an injection-site haematoma in individuals with any bleeding disorder, such as haemophilia or thrombocytopaenia, or in individuals on anticoagulant therapy, intramuscular injections with Fluzone High-Dose should not be administered to such individuals unless the potential benefits outweigh the risk of administration. If the decision is made to administer any product by intramuscular injection to such individuals, it should be given with caution, with steps taken to avoid the risk of haematoma formation following injection.
Febrile or acute disease. Vaccination should be postponed in case of a moderate or severe acute disease with or without fever; however, a mild disease should not usually be a reason to postpone vaccination.
Syncope. Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury and to manage syncope.
Use in the elderly. Fluzone High-Dose is intended for adults 60 years of age and over (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
Paediatric use. Safety and effectiveness of Fluzone High-Dose in children less than 18 years of age have not been established.
Effects on laboratory tests. Interference of Fluzone High-Dose with laboratory and/or diagnostic tests has not been studied.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, hepatitis C, and especially HTLV1 have been observed. An appropriate Western Blot test should be used to confirm or disprove the results of the ELISA test. The transient false-positive reactions could be due to a non-specific IgM response induced by the vaccine.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Fluzone High-Dose should not be mixed with any other vaccine in the same syringe or vial.
Co-administration of Fluzone High-Dose with an investigational booster 100 microgram dose of COVID-19 mRNA vaccine (nucleoside modified/elasomeran) has been evaluated in a limited number of participants in a descriptive clinical study (see Section 4.8 Adverse Effects (Undesirable Effects); Section 5.1 Pharmacodynamic Properties).
If Fluzone High-Dose is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
If the vaccine is used in individuals deficient in producing antibodies due to immunosuppressive therapy, the expected immune response may not be obtained.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. Fluzone High-Dose has not been evaluated for possible effects on human fertility.
Use in pregnancy. (Category B2)
Animal reproduction studies have not been conducted with Fluzone High-Dose. It is also not known whether Fluzone High-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Data on the use of this vaccine in pregnant women are limited. Fluzone High-Dose should be given to pregnant women only if clearly needed and following an assessment of the risks and benefits.
Use in lactation. There are no available data on the presence of Fluzone High-Dose in human milk, effects on milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not Fluzone High-Dose is safe for use during breastfeeding. Fluzone High-Dose should be used during breastfeeding only if the potential benefits to the mother outweigh the potential risks, including those to the breastfed child.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive or use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

Summary of the safety profile. Fluzone High-Dose is identical to Fluzone High-Dose Quadrivalent (inactivated quadrivalent influenza vaccine, QIV HD) with the only difference of containing antigen from one less influenza B strain. The safety profile of QIV-HD is therefore relevant to the use of Fluzone High-Dose.
The safety of QIV-HD was assessed in a pooled analysis of two clinical trials (QHD00013 and QHD00011) in which 2549 adults from 60 years of age and older (378 adults from 60 to 64 years of age and 2171 adults 65 years of age and older) received QIV-HD.
The most frequently reported adverse reaction after vaccination was injection site pain reported by 42.6% of study participants followed by myalgia (23.8%), headache (17.3%), and malaise (15.6%). Most of these reactions occurred and resolved within three days of vaccination. The intensity of most of these reactions was mild to moderate.
Overall, adverse reactions were generally less frequent in participants aged 65 years and older than in participants aged 60 to 64 years.
Reactogenicity of QIV-HD was slightly increased as compared to the standard dose vaccine, but no major difference in intensity was observed.
The safety of QIV-HD was evaluated in a descriptive study (QHD00028) in which subjects received QIV-HD together with an investigational booster 100 microgram dose of COVID-19 mRNA vaccine (nucleoside modified) (n = 100), QIV-HD only (n = 92) or an investigational booster 100 microgram dose of COVID-19 mRNA vaccine (nucleoside modified) only (n = 104). The frequency and severity of local and systemic adverse reactions was similar in subjects who were co-administered with QIV-HD and licensed COVID-19 mRNA vaccine and subjects administered with a booster dose of licensed COVID-19 mRNA vaccine.
Tabulated list of adverse reactions. Table 1 summarizes the frequencies of adverse reactions that were recorded following vaccination with QIV-HD and adverse reactions reported during clinical development and post-marketing experience with the trivalent and the quadrivalent influenza high-dose vaccines.
Adverse events are ranked under headings of frequency using the following convention: 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); very rare (< 1/10,000); not known (cannot be estimated from available data).

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

Cases of administration of more than the recommended dose have been reported Fluzone High-Dose associated with inadvertent use in the population below 60 years of age due to medication error. When adverse reactions were reported, the information was consistent with the known safety profile of Fluzone High-Dose.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB.
Mechanism of action. Influenza illness and its complications like primary viral or secondary bacterial pneumonia, serious cardiac events, and neurologic complications as well as exacerbation of underlying conditions like congestive heart failure, chronic obstructive pulmonary disease (COPD), asthma, and diabetes follow infection with influenza viruses. Global surveillance of influenza identifies yearly antigenic variants. For example, since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Specific levels of hemagglutination inhibition (HAI) antibody titre post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza virus infection.
Antibodies against one influenza virus type or subtype confer limited or no protection against another. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virological basis for seasonal epidemics and the reason for the usual change of one or more strains in each year's influenza vaccine. Therefore, influenza vaccines are standardized to contain the haemagglutinins of influenza virus strains representing the influenza viruses likely to be circulating in the upcoming season.
Annual influenza vaccination is recommended because immunity during the year after vaccination declines and because circulating strains of influenza virus change from year to year.
Clinical trials. Clinical efficacy. FIM12. FIM12 was a multi-centre, double-blind efficacy trial conducted in the US and Canada in which adults 65 years of age and older were randomised (1:1) to receive either Fluzone High-Dose or a standard dose influenza vaccine. The study was conducted over two influenza seasons (2011-2012 and 2012-2013) to assess the occurrence of laboratory-confirmed influenza caused by any influenza viral type/subtype in association with influenza-like illness (ILI) as the primary endpoint.
Participants were monitored for the occurrence of a respiratory illness by both active and passive surveillance, starting 2 weeks post-vaccination for approximately 7 months. After an episode of respiratory illness, nasopharyngeal swab samples were collected for analysis; attack rates and vaccine efficacy were calculated. See Table 2.

For the supplementary analysis, selected serious cardiorespiratory events reported in FIM12 were grouped into 7 pre-specified categories and represented the following endpoints: pneumonia events, asthma/chronic obstructive pulmonary disease (COPD)/bronchial events, influenza events (serious laboratory-confirmed influenza diagnosed outside study procedures by a subject's healthcare provider), other respiratory events, coronary artery events, congestive heart failure events and cerebrovascular events.
For both years combined, there was a significant reduction in the total number of serious cardiorespiratory events (relative vaccine efficacy (rVE), 17.7% [95% CI: 6.6%-27.4%]) among Fluzone High-Dose recipients compared to standard dose influenza vaccine recipients, including a significant reduction in serious pneumonia events (rVE, 39.8% [95% CI: 19.3%-55.1%]). In addition, a borderline significant reduction in all-cause hospitalisation (rVE, 6.9%; 95% CI: 0.5%-12.8%) was observed. It is noted that most of the reductions in the Fluzone High-Dose group were observed in Year 2 with no significant differences observed in Year 1.
Immunogenicity. FIM05. FIM05 was a multi-centre, randomised, double-blind controlled trial conducted in the US in adults 65 years and older. The objective was to demonstrate the superiority of Fluzone High-Dose over a standard dose inactivated influenza vaccine containing 15 microgram of each strain (2 A strains and 1 B strain), as assessed by seroconversion rates and GMTs.
The immunogenicity results of the FIM05 Phase 3 study on Fluzone High-Dose are summarised in Table 3.
According to the criteria set in the protocol, Fluzone High-Dose elicited a superior immune response compared to a standard dose trivalent inactivated influenza vaccine for both seroconversion rates and GMTs.
QHD00013. QHD00013 was a randomised, active-controlled, modified double-blind Phase III clinical trial conducted in the US (NCT 03282240) in adults 65 years and older.
The objective was to demonstrate the noninferiority of QIV-HD over Fluzone High-Dose, as assessed by HAI (hemagglutinin inhibition) geometric mean antibody titres (GMTs) at Day 28 and seroconversion rates.
A total of 2670 adults from 65 years of age were randomised to receive either one dose of QIV HD or one dose of Fluzone High-Dose (one of two formulations of comparator vaccine [TIV HD1 or TIV HD2]); each Fluzone High-Dose formulation contained a B strain that corresponds to one of the two B strains in QIV-HD (either a B strain of the Yamagata lineage or a B strain of the Victoria lineage). The mean age was 72.9 years in the QIV-HD group (ranged from 65 through 100 years) and the mean age was 73.0 in the Fluzone High-Dose group (ranged from 65 through 95 years). 35.4% of participants in the QIV-HD group and 35.8% of participants in the Fluzone High-Dose group were 75 years of age or older.
The immunogenicity results of QIV-HD in the QHD00013 study are summarised in Table 4.
These data strongly support Fluzone High-Dose being as immunogenic as QIV-HD for all 3 strains in common, and thus allow inferring the immunogenicity, efficacy and effectiveness results of QIV-HD to Fluzone High-Dose.
QHD00011. The immunogenicity of QIV-HD is relevant to Fluzone High-Dose because both vaccines are manufactured using the same process and have overlapping compositions.
QHD00011 was a randomised, active-controlled, modified double-blind, Phase III, clinical trial conducted in Europe in adults 60 years and older to demonstrate the superiority of QIV HD over QIV-SD for all strains, as assessed by HAI (hemagglutinin inhibition) geometric mean antibody titers (GMTs) at Day 28 in adults 60 to 64 years of age and in adults 65 years of age and older.
A total of 1539 adults (760 adults 60 to 64 years of age and 779 adults 65 years of age and older) were randomised to receive either one dose of QIV-HD or one dose of QIV-SD. See Table 5.
QIV-HD induced a superior immune response to QIV-SD for all 4 virus strains 28 days post-vaccination in adults 60 to 64 years of age, and this response was at least similar to the immune response in adults 65 years and above. The efficacy and effectiveness data from 65 years of age and above can thus be inferred to adults from 60 years of age and above.
Effectiveness of Fluzone High-Dose in adults 65 years of age and older. Randomised clinical trials. A cluster-randomised, controlled clinical trial in United States nursing homes assessed the relative effect of Fluzone High-Dose versus a standard dose of influenza vaccine in hospitalisations among 53,008 individuals during the 2013-2014 influenza season.
During the 2013-2014 season, when adjusting for the pre-specified patient and facility characteristics, the incidence of respiratory-related hospital admissions (primary objective) was significantly reduced in facilities where residents received Fluzone High-Dose compared with those that received standard dose influenza vaccines by 12.7% (adjusted risk ratio [ARR] 0.873, 95% CI 0.776 to 0.982, p = 0.023). Moreover, with respect to secondary endpoints, Fluzone High-Dose reduced hospital admissions for pneumonia by 20.9% (ARR 0.791, 95% CI: 0.267 to 0.953, p = 0.013) and all-cause hospital admissions by 8% (ARR 0.915, 95% CI: 0.863 to 0.970, p = 0.0028).
Observational studies. Several retrospective studies, over 11 influenza seasons and in more than 45 million individuals 65 years of age and older, confirmed the superior protection offered by Fluzone High-Dose compared to standard dose influenza vaccines against complications of influenza such as pneumonia hospitalisation (13.4% (95% CI: 7.3% to 19.2%, p < 0.001)), cardio-respiratory hospitalisations 17.9% (95% CI :14.7% to 21%, p < 0.001) and all cause hospitalisation 7.8% (95% CI: 5.9% to 10.3%, p < 0.001); although the impact may vary per season.
Concomitant administration with COVID-19 mRNA vaccine (nucleoside modified). In a descriptive open-label clinical study (NCT04969276), healthy adults aged 65 years and older were divided in three groups: group 1 received QIV-HD alone (N = 92), group 2 (N = 100) received QIV-HD concomitantly with an investigational booster 100 microgram dose of COVID-19 mRNA vaccine (nucleoside modified) at least 5 months after the second dose of the primary series, group 3 (N = 104) received only the investigational booster 100 microgram dose of COVID-19 mRNA vaccine (nucleoside modified).
Co-administration resulted in no change to influenza vaccine immune responses as measured by hemagglutination inhibition (HAI) assay. Co-administration resulted in similar responses to COVID-19 mRNA vaccine, as assessed by an anti-spike IgG assay (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.8 Adverse Effects (Undesirable Effects)).

5.2 Pharmacokinetic Properties

No pharmacokinetic studies have been performed.

5.3 Preclinical Safety Data

Genotoxicity. Fluzone High-Dose has not been tested for genotoxic potential.
Carcinogenicity. Fluzone High-Dose has not been tested for carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Fluzone High-Dose contains sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, octoxinol-9 and water for injections as excipients.
Fluzone High-Dose may also contain traces of formaldehyde (≤ 140 microgram) and ovalbumin (≤ 1 microgram). Neither antibiotics nor preservative are used during manufacture.

6.2 Incompatibilities

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

6.3 Shelf Life

12 months.

6.4 Special Precautions for Storage

Store at 2°C to 8°C (Refrigerate, Do not freeze). Discard if vaccine has been frozen.

6.5 Nature and Contents of Container

Fluzone High-Dose is available as a 0.5 mL single-dose, pre-filled syringe without needle. Pack of 5 syringes.

6.6 Special Precautions for Disposal

After use, any remaining vaccine and container must be disposed of safely, according to locally acceptable procedures.

7 Medicine Schedule (Poisons Standard)

S4 Prescription Only Medicine.

Date of First Approval

02 January 2026

Summary Table of Changes