Cell-based Quadrivalent Influenza vaccine (Surface antigen Inactivated) Seqirus for injection – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe.

Influenza vaccine, prepared in cell cultures

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:

A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) 15 micrograms HA**

A/Massachusetts/18/2022 (H3N2)-like strain (A/Sydney/1304/2022, wild type) 15 micrograms HA**

B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 15 micrograms HA**

B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15 micrograms HA**

per 0.5 ml dose

……………………………………….

* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin

The vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2024/2025 season.

Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Suspension for injection in pre-filled syringe (injection). Clear to slightly opalescent liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Prophylaxis of influenza in adults and children from 6 months of age.

Cell-based Quadrivalent Influenza Vaccine Seqirus should be used in accordance with official recommendations.

4.2 Posology and method of administration

Posology

Adults and children from 6 months of age:

^a Children less than 9 years of age who have not been previously vaccinated against influenza, should receive a second dose.

The safety and efficacy of Cell-based Quadrivalent Influenza Vaccine Seqirus in children from birth to less than 6 months of age has not been established.

Method of administration

For intramuscular injection only.

The preferred site for injection is the deltoid muscle of the upper arm. Young children with insufficient deltoid mass should be vaccinated in the anterolateral aspect of the thigh.

The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.

For instructions on the handling of the vaccine before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to possible trace residues such as beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.

4.4 Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Vaccination should be postponed in patients with febrile illness until the fever is resolved.

As with all injectable vaccines, Cell-based Quadrivalent Influenza Vaccine Seqirus must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza.

A protective immune response may not be elicited in all vaccine recipients.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with Cell-based Quadrivalent Influenza Vaccine Seqirus. Concomitant administration of Cell-based Quadrivalent Influenza Vaccine Seqirus with other vaccines has not been studied in trials conducted by Seqirus. Based on clinical experience with cell-based trivalent influenza vaccine (TIVc), Cell-based Quadrivalent Influenza Vaccine Seqirus can be given at the same time as other vaccines. If Cell-based Quadrivalent Influenza Vaccine Seqirus is to be used at the same time as another vaccine, it should be administered at separate injection sites and preferably on different limbs. It should be noted that the adverse reactions may be intensified.

Data assessed by the MHRA that support concomitant administration of influenza vaccines with COVID-19 vaccines (but at separate injection sites) are based on the ComFluCOV study [EudraCT Number: 2021-001124-18], which investigated concomitant administration in adults of Cell-based Quadrivalent Influenza Vaccine Seqirus with COVID-19 mRNA Vaccine BNT162b2 (Pfizer/BioNTech) and COVID-19 Vaccine AstraZeneca. The data show that the antibody responses are unaffected and that the reactogenicity profile is acceptable.

4.6 Fertility, pregnancy and lactation

Pregnancy

Inactivated influenza vaccines, such as Cell-based Quadrivalent Influenza Vaccine Seqirus, can be given in any stage of pregnancy. Larger safety datasets are available on vaccine use during the second or third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccines do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.

A prospective Pregnancy Exposure Registry was conducted in the United States (US) and data were collected from 665 women vaccinated with Cell-based Quadrivalent Influenza Vaccine Seqirus during 3 Northern Hemisphere influenza seasons (2017-18 to 2019-20), of whom 28% were exposed during their first trimester. Based on pregnancy outcomes and predefined infant safety outcomes, there was no evidence of adverse foetal, newborn or pregnancy outcomes attributable to the vaccine during any stage of pregnancy.

There have been no reproductive and developmental toxicology studies with Cell-based Quadrivalent Influenza Vaccine Seqirus. Reproductive and developmental toxicology data from cell-based trivalent influenza vaccine (TIVc) do not predict an increased risk of developmental abnormalities.

Breast-feeding

It is unknown whether Cell-based Quadrivalent Influenza Vaccine Seqirus is excreted in human milk. No effects on breast fed newborn/infant are anticipated. Cell-based Quadrivalent Influenza Vaccine Seqirus may be given during lactation.

Fertility

No human fertility data are available. Animal data, with cell-based trivalent influenza vaccine (TIVc), have not shown effects on female fertility. Male fertility has not been assessed in animals.

4.7 Effects on ability to drive and use machines

Cell-based Quadrivalent Influenza Vaccine Seqirus has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of the safety profile

The safety of Cell-based Quadrivalent Influenza Vaccine Seqirus in adults 18 years and older was evaluated in a randomised, controlled study (V130_01), in which 1 334 subjects received Cell-based Quadrivalent Influenza Vaccine Seqirus. Similar rates of solicited local and systemic adverse reactions were reported in subjects who received Cell-based Quadrivalent Influenza Vaccine Seqirus and cell-based trivalent influenza vaccine comparator in this clinical trial.

The most commonly reported (≥10%) reactions in subjects who received Cell-based Quadrivalent Influenza Vaccine Seqirus were pain at the injection site (34%), headache (14%), fatigue (14%), myalgia (12%), injection site erythema (13%) and injection site induration (10%).

The incidence of some adverse reactions were considerably lower among subjects ≥ 65 years of age when compared to subjects 18 to < 65 years of age (see table below).

Tabulated list of adverse reactions

Adverse reactions reported 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), not known (cannot be estimated from the available data).

Table 1: Adverse reactions reported following vaccination in adults 18 years and older in clinical trials and post-marketing surveillance.

¹ Reported as Common in the elderly population 65 years of age and older

² Reported as Uncommon in the elderly population 65 years of age and older

³ Adverse reactions reported from post-marketing surveillance

Paediatric population (6 months to less than 18 years of age)

The safety of Cell-based Quadrivalent Influenza Vaccine Seqirus in children 6 months to less than 18 years of age has been evaluated in four clinical studies, V130_03, V130_12, V130_10 and V130_14. In these studies, 5 221 subjects 6 months to less than 6 years of age, and 2 649 subjects 6 years to less than 18 years of age received Cell-based Quadrivalent Influenza Vaccine Seqirus. Children less than 9 years of age received either one or two doses (separated by 28 days) based on their previous influenza vaccination history and all children 9 years to less than 18 years of age received one dose. Among subjects 6 months to less than 6 years of age, 1 177 received one dose and 4 043 received two doses. Among children 6 years to less than 9 years of age, 338 received one dose and 615 received two doses.

The most common local and systemic adverse reactions reported across the four studies are described by paediatric sub-group with the highest percentage reported from any of the four studies shown in Table 2 below.

The most common (≥10%) local and systemic adverse reactions after any vaccination in children 6 months to less than 6 years of age were tenderness at the injection site (54%), irritability (28%), sleepiness (27%), injection site erythema (26%), diarrhoea (18%), injection site induration (17%), change in eating habits (17%), injection site ecchymosis (11%) and fever (11%).

The most common (≥10%) local and systemic adverse reactions after any vaccination in children 6 years to less than 18 years of age were pain at the injection site (61%), injection site erythema (25%), headache (22%), injection site induration (19%), fatigue (18%), myalgia (16%), injection site ecchymosis (11%) and loss of appetite (11%).

Compared to adults 18 years of age and older, paediatric subjects generally reported higher rates of local and systemic adverse reactions.

In children who received a second dose of Cell-based Quadrivalent Influenza Vaccine Seqirus the incidence of adverse reactions following the second dose of vaccine was similar or slightly lower to that observed with the first dose.

The highest frequency of adverse reactions in children 6 months to less than 18 years of age in these clinical studies are described in Table 2 below.

Table 2: Solicited adverse reactions reported in clinical studies in children 6 months to <

18 years of age

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

There are no data for overdose with Cell-based Quadrivalent Influenza Vaccine Seqirus.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB02

Mechanism of action

Cell-based Quadrivalent Influenza Vaccine Seqirus provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine. Cell-based Quadrivalent Influenza Vaccine Seqirus induces humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses.

Cell-based Quadrivalent Influenza Vaccine Seqirus is manufactured using Madin Darby Canine Kidney (MDCK) cells.

Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus. In some human studies, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects.

Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.

Annual revaccination with current influenza vaccines is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus may change from year to year.

Pharmacodynamic effects

Immunogenicity of Cell-based Quadrivalent Influenza Vaccine Seqirus in Adults 18 years of age and older

Immunogenicity of Cell-based Quadrivalent Influenza Vaccine Seqirus was evaluated in adults 18 years of age and older in a randomised, double-blind, controlled study (V130_01). In this study, subjects received Cell-based Quadrivalent Influenza Vaccine Seqirus (N = 1 334) or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 677) or TIV2c (N = 669)]. The immune response to each of the vaccine antigens was assessed, 21 days after vaccination.

The immunogenicity endpoints were geometric mean antibody titres (GMTs) of haemagglutination inhibition (HI) antibodies response and percentage of subjects who achieved seroconversions, defined as a pre-vaccination HI titre of <1:10 with a post vaccination titre ≥1:40 or with a pre-vaccination HI titre of ≥10 and a minimum 4-fold increase in serum HI antibody titre.

Cell-based Quadrivalent Influenza Vaccine Seqirus was non-inferior to TIVc. Non-inferiority was established for all 4 influenza strains included in Cell-based Quadrivalent Influenza Vaccine Seqirus, as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 3 weeks following vaccination. The antibody response to influenza B strains contained in Cell-based Quadrivalent Influenza Vaccine Seqirus was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage. There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.

Age subgroup analyses in subjects 18 to less than 65 years of age and 65 years of age and above confirmed that HI antibody responses (GMT and differences in vaccine group seroconversion rates) met non-inferiority immunogenicity criteria 3 weeks following vaccination for all 4 influenza strains in both age groups.

The non-inferiority data observed are summarised in Table 3.

Table 3: Noninferiority of Cell-based Quadrivalent Influenza Vaccine Seqirus relative to TIVc in adults 18 years of age and above – Per protocol analysis set (V130_01)

Abbreviations: GMT = geometric mean titre; CI = confidence interval.

^a The comparator vaccine for noninferiority comparisons for A/H1N1, A/H3N2 and B1 is TIV1c, for B2 it is TIV2c.

^b Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.

Bold = Non-inferiority criterion met.

Clinical efficacy of cell-based trivalent influenza vaccine (TIVc) against culture-confirmed influenza in adults

The efficacy experience with TIVc is relevant to Cell-based Quadrivalent Influenza Vaccine Seqirus because both vaccines are manufactured using the same process and have overlapping compositions.

A multinational, randomised, observer-blinded, placebo-controlled trial (V58P13) was performed to assess clinical efficacy and safety of TIVc during the 2007-2008 influenza season in adults aged 18 to less than 50 years. A total of 11,404 subjects were enrolled to receive TIVc (N = 3 828), Agrippal (N = 3 676) or placebo (N = 3 900) in a 1:1:1 ratio.

TIVc efficacy was defined as the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine compared to placebo. Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI). ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral temperature ≥100.0°F / 38°C) and cough or sore throat. After an episode of ILI, nose and throat swab samples were collected for analysis. Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were calculated (Table 4).

Table 4: Comparative efficacy of TIVc versus placebo against culture-confirmed influenza by influenza viral subtype (V58P13)

^* Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks.

Vaccine Efficacy = (1 - Relative Risk) x 100%;

^** There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately assess vaccine efficacy.

Paediatric population

Immunogenicity of Cell-based Quadrivalent Influenza Vaccine Seqirus in Children and Adolescents 6 months to less than 18 Years of Age

Immunogenicity of Cell-based Quadrivalent Influenza Vaccine Seqirus in the paediatric population was evaluated in 2 clinical studies, V130_03 and V130_10.

Immunogenicity of Cell-based Quadrivalent Influenza Vaccine Seqirus was evaluated in children 4 years to less than 18 years of age as part of a randomised, double-blind, controlled study (V130_03). In this study, subjects received Cell-based Quadrivalent Influenza Vaccine Seqirus (N = 1 159) or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 593), or TIV2c (N = 580)]. The immune response to each of the vaccine antigens was assessed 21 days after vaccination.

The immunogenicity endpoints were GMTs of HI antibodies response and percentage of subjects who achieved seroconversions (seroconversion rate), defined as a pre-vaccination HI titre of <1:10 with a post-vaccination titre ≥1:40 or with a pre-vaccination HI titre ≥ 1:10 and a minimum 4-fold increase in serum HI antibody titre.

Cell-based Quadrivalent Influenza Vaccine Seqirus was noninferior to TIVc in children 4 years to less than 18 years of age. Non-inferiority was established for all 4 influenza strains included in the Cell-based Quadrivalent Influenza Vaccine Seqirus, as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 3 weeks following vaccination. The antibody response to influenza B strains contained in Cell-based Quadrivalent Influenza Vaccine Seqirus was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage. There was no evidence that the addition of the second B strain resulted in immune interference to other strains included in the vaccine.

The immunogenicity data in subjects 4 years to less than 18 years of age are summarised in Table 5.

Table 5: GMTs and seroconversion rates (with 95% CI) in subjects 4 to <18 years of age, 3 weeks after vaccination with Cell-based Quadrivalent Influenza Vaccine Seqirus or TIV1c/TIV2c - Per Protocol Set (V130_03)

^a For H1N1, H3N2 and B1 influenza strains TIV1c data are presented, whereas for B2 influenza strain TIV2c data are presented.

^b Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.

Bold- CHMP immunogenicity criteria met. The percentage of subjects with seroconversion or significant increase in HI antibody titre is >40%, the percentage of subjects achieving an HI titre ≥1:40 is >70%.

Immunogenicity of Cell-based Quadrivalent Influenza Vaccine Seqirus was evaluated in children 6 months to less than 4 years of age in a randomised, observer-blind, multicentre study conducted in the US (Study V130_10). In this study, subjects received Cell-based Quadrivalent Influenza Vaccine Seqirus or a comparator quadrivalent influenza vaccine (Cell-based Quadrivalent Influenza Vaccine Seqirus N=1 597, Comparator QIV N=805). In the per protocol set, the mean age of subjects who received Cell-based Quadrivalent Influenza Vaccine Seqirus was 29 months. The immune response to each of the vaccine antigens was assessed, 28 days after last vaccination.

The immunogenicity endpoints were geometric mean antibody titres (GMTs) and percentage of subjects who achieved seroconversion, defined as a pre-vaccination HI or MN titre of <1:10 with a post-vaccination titre ≥1:40 or with a pre-vaccination HI or MN titre ≥ 1:10 and a minimum 4-fold increase in serum antibody titre. GMTs and seroconversion rates were measured by haemagglutination inhibition (HI) assay for A/H1N1, B/Yamagata and B/Victoria strains and by microneutralization (MN) assay for the A/H3N2 strain.

Cell-based Quadrivalent Influenza Vaccine Seqirus was noninferior to the Comparator QIV. Noninferiority was established for all 4 influenza strains as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 4 weeks following vaccination (see Table 6).

Table 6: Noninferiority of Cell-based Quadrivalent Influenza Vaccine Seqirus Relative to Comparator QIV in Children 6 Months to Less Than 4 Years of Age – Per-Protocol Analysis Set (V130_10)

Abbreviations: GMT = Geometric Mean Titre. CI = Confidence Interval.

Assays: GMTs and seroconversion rates were measured by haemagglutination inhibition (HI) assay for A/H1N1, B/Yamagata and B/Victoria strains and by microneutralization (MN) assay for the A/H3N2 strain, using cell-derived target viruses.

^a Seroconversion rate = percentage of subjects with either a pre-vaccination titre < 1:10 and post-vaccination titre ≥ 1:40 or with a pre-vaccination titre ≥ 1:10 and a minimum 4-fold increase in post-vaccination antibody titre

Bold = Non-inferiority criterion met

Clinical efficacy of Cell-based Quadrivalent Influenza VaccineSeqirus in the paediatric population 6 months to less than 18 years of age

Absolute efficacy of Cell-based Quadrivalent Influenza Vaccine Seqirus was evaluated in children 2 years to less than 18 years of age in Study V130_12 and in children 6 months to less than 48 months, in Study V130_14.

Study V130_12 was a multinational, randomised, non-influenza vaccine comparator-controlled efficacy study conducted in 8 countries over 3 influenza seasons, in which 4 514 subjects were enrolled to received 0.5 ml of Cell-based Quadrivalent Influenza Vaccine Seqirus or a non-influenza comparator in a 1:1 ratio. Based on influenza vaccination history, participants received one or two doses (28 days apart) of the study vaccine.

Cell-based Quadrivalent Influenza Vaccine Seqirus efficacy was assessed by the prevention of confirmed influenza illness caused by any influenza Type A or B strain. Influenza cases were identified by active surveillance of influenza-like illness (ILI) and confirmed by viral culture and/or real-time polymerase chain reaction (RT-PCR). An ILI episode was defined as a fever body temperature ≥ 37.8°C) along with at least one of the following: cough, sore throat, nasal congestion, or rhinorrhoea. Vaccine efficacy against laboratory confirmed influenza was calculated (Table 7).

Table 7: Number of Subjects with First-Occurrence RT-PCR Confirmed or

Culture Confirmed Influenza and Absolute Vaccine Efficacy (95% CI), in Subjects 2 years to less than 18 Years of Age– FAS Efficacy1 (Study V130_12)

¹Number of subjects in the Full-Analysis Set (FAS)– Efficacy, which included all subjects randomised, received a study vaccination and provided efficacy data.

In Study V130_14, absolute efficacy of Cell-based Quadrivalent Influenza Vaccine Seqirus was evaluated in children 6 months to less than 48 months of age. This was a multicentre, randomised, observer-blind, non-influenza vaccine comparator-controlled efficacy study conducted in 15 countries over 5 influenza seasons. In the study, 5 697 subjects received either Cell-based Quadrivalent Influenza Vaccine Seqirus (N=2 857) or a non-influenza vaccine comparator (N=2 840) in a 1:1 ratio. The full analysis set (FAS) for efficacy consisted of 5 691 subjects. Based on influenza vaccination history, participants received one or two doses (28 days apart) of the study vaccine.

Vaccine efficacy was assessed by the prevention of confirmed influenza illness caused by any influenza Type A or B strain. Influenza cases were identified by active surveillance of influenza-like illness (ILI) and confirmed by real-time polymerase chain reaction (RT-PCR) and viral culture. An ILI episode was defined as a fever body temperature ≥ 37.8°C with at least one of the following on the same day: cough, sore throat, nasal congestion, rhinorrhoea, earache or ear discharge. Vaccine efficacy against laboratory confirmed influenza was calculated (Table 8)

Table 8: Absolute vaccine efficacy (95% CI) in subjects 6 months to less than 4 years of age – FAS Efficacy¹ (Study V130_14)

¹ Number of subjects in the Full-Analysis Set (FAS) – Efficacy, which included all subjects randomised, received a study vaccination and provided efficacy data

² Primary endpoint of study

³ The number of subjects with first occurrence of moderate-to-severe RT-PCR confirmed influenza was 9 in the comparator group and 0 in the cell-based quadrivalent influenza vaccine group.

⁴ The pre-defined success criterion was defined as the lower limit of the two-sided 97.98% CI of absolute vaccine efficacy was above 0%

⁵ Culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains in the vaccine (two-sided 95% CI)

⁶ The pre-defined success criterion was defined as the lower limit of the two-sided 97.5% CI of absolute vaccine efficacy was above 0%

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 and toxicity to reproduction and development.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride

Potassium chloride

Magnesium chloride hexahydrate

Disodium phosphate dihydrate

Potassium dihydrogen phosphate

Water for injections

6.2 Incompatibilities

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

6.3 Shelf life

12 months

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

6.5 Nature and contents of container

0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber), with or without needle.

Pack of 1 pre-filled syringe, with or without needle

Pack of 10 pre-filled syringes, with or without needles.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Shake before use. After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.

The vaccine should be visually inspected for particulate matter and discoloration prior to administration. In the event of any foreign particulate matter and/or variation of physical aspect is observed, do not administer the vaccine.

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

7 MARKETING AUTHORISATION HOLDER

Seqirus UK Ltd.

The Point, 29 Market Street,

Maidenhead SL6 8AA, UK

8 MARKETING AUTHORISATION NUMBER(S)

PLGB 47991/0006

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

17/12/2025

10 DATE OF REVISION OF THE TEXT

17/12/2025