TRUMENBA^® suspension for injection in pre-filled syringe Meningococcal group B vaccine (recombinant, adsorbed)

ABBREVIATED PRESCRIBING INFORMATION – IRELAND

Please refer to the Summary of Product Characteristics (SmPC) before prescribing TRUMENBA. Presentation: Each 0.5ml dose of Trumenba contains 60 μg of Neisseria meningitidis serogroup B fHbp subfamily A^1,2,3 and 60 μg of Neisseria meningitidis serogroup B fHbp subfamily B^1,2,3. ¹ Recombinant lipidated fHbp (factor H binding protein); ² Produced in Escherichia coli cells by recombinant DNA technology;³ Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose).

Indications: Active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

Dosage and Administration: For intramuscular injection only. Two-dose primary series: 2 doses administered at a 6 month interval. Three-dose primary series: Alternatively 2 doses administered at least 1 month apart, followed by a third dose at least 4 months after the second dose. Booster dose: A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease. There are no data available on the interchangeability of Trumenba with other meningococcal group B vaccines to complete the vaccination series. Safety and efficacy of Trumenba in children younger than 10 years of age have not been established. Currently available data in infants and for children 1 to 9 years of age are described in the SmPC; however, no recommendation on a posology can be made as data are limited. Trumenba should not be used in infants aged 2 to 6 months because of safety concerns.

Contraindications: Hypersensitivity to the active substances or to any of the excipients.

Special warnings and precautions for use: Trumenba should not be administered intravenously, intradermally, or subcutaneously. In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded. Appropriate medical treatment should always be readily available in case of anaphylactic reactions following administration of the vaccine. Postpone vaccination in acute febrile illness, however, the presence of a minor infection, such as cold, should not result in the deferral of vaccination. Trumenba should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration. As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients. There are no data on the use of Trumenba in immunocompromised individuals. Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Trumenba. Individuals with familial complement deficiencies (for example, C5 or C3 deficiencies) and patients receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B, even if they develop antibodies following vaccination with Trumenba. There are limited data on the use of Trumenba in individuals 40 to 65 years of age and there are no data on the use of Trumenba in individuals older than 65 years of age. As with other injectable vaccines, syncope (fainting) can occur in association with administration of Trumenba. Procedures should be in place to avoid injury from fainting. This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Individuals on low sodium diets can be informed that this medicinal product is essentially sodium-free.

Immune response: The immunogenicity of Trumenba includes results from Phase 2 and Phase 3 clinical studies following the 2-dose schedule (0 and 6 months) in subjects 10 to 25 years of age in the US and Europe (Study B1971057); following the 3-dose schedule (0, 2, and 6 months) in subjects 10 to 25 years of age globally (Studies B1971009 and B1971016); and following the 2-dose (0 and 6 months) and 3-dose schedules (0, 1-2, and 6 months) in subjects 11 to 18 years of age in Europe (Study B1971012). An hSBA titre of ≥ 1:4 is assumed to be protective against meningococcal disease. In the immunogenicity analysis for Trumenba, a more conservative hSBA titre threshold of ≥ 1:8 or 1:16 was applied, depending on the hSBA strain. Vaccine coverage was investigated using four primary representative meningococcal serogroup B test strains: two expressing subfamily A fHbp (variants A22 and A56) and two expressing subfamily B fHbp (variants B24 and B44). To support and further extend the breadth of vaccine coverage, an additional 10 meningococcal serogroup B test strains were used; these included six expressing subfamily A fHbp (variants A06, A07, A12, A15, A19 and A29) and four expressing subfamily B fHbp (variants B03, B09, B15 and B16). In the Phase 3 Study B1971057, subjects 10 to 25 years of age received Trumenba at months 0 and 6 (coadministered with MenACWY-CRM for the first dose) or an investigational pentavalent meningococcal vaccine at months 0 and 6. A total of 1,057 subjects received Trumenba and 543 subjects received the investigational control. The hSBA titres for primary test strains were: A22 91.0%, A56 99.4%, B24 79.3% and B44 94.5%. The hSBA composite response (for all 4 hSBA strains combined) observed after post-dose 2 was 74.3%. The hSBA titres against the additional 10 test strains which support and extend the breadth of vaccine coverage were: A06 89.3%, A07 96.8%, A12 83.4%, A15 89.1%, A19 90.4%, A29 95.2%, B03 74.4%, B09 71.1%, B15 85.0% and B16 77.4%. In Studies B1971009 and B1971016, the proportion of subjects achieving a hSBA titre ≥ 1:8 (variants A07, A15, A19, A29, B03, B09, B15, B16) or 1:16 (variants A06, A12, A19) against the 10 additional test strains after 3 doses of Trumenba, administered on a 0-, 2-, and 6-month schedule, was determined. Across the two studies, the majority of subjects, ranging from 71.3% to 99.3% for the 6 subfamily A fHbp strains and 77.0% to 98.2% for the 4 subfamily B fHbp strains, achieved a hSBA titre ≥ 1:8 or 16, consistent with the results observed with the 4 primary test strains. In Phase 2 Study B1971012, hSBA titres following completion of two 3‑dose schedules (0, 1, and 6 months and 0, 2, and 6 months) and a 2‑dose schedule (0 and 6 months) were determined against the 4 primary test strains. At 1 month after the third dose, similar robust and broad immune responses were observed for both 3-dose schedules with 86.1% to 99.4% achieving hSBA titres ≥ 1:8 or 16 and 74.6% to 94.2% achieving a 4-fold increase in hSBA titre. At 1 month after completion of the 2-dose schedule (0 and 6 months), 77.5% to 98.4% achieved hSBA titres ≥ 1:8 or 16 and 65.5% to 90.4% achieved a 4-fold increase in hSBA titre. Persistence of immunity and response to booster vaccination was investigated in Study B1971033, an open-label, follow-up study of subjects previously enrolled in a primary study, including Study B1971012. Subjects received a single booster dose of Trumenba approximately 4 years after receipt of a primary series of Trumenba. A booster response was observed as measured by hSBA at 1 month following the dose of Trumenba approximately 4 years after a primary series of 2 doses (Group 3) or 3 doses (Groups 1 and 2). The hSBA composite responses (for all 4 hSBA strains combined) after third dose for Groups 1, 2, and the second dose for Group 3 from Study B1971012 were: Group1 19.6%, Group 2 30.2% and Group 3 9.8% 48 months after last primary dose and 26 months after booster dose were Group 2 48.1% and Group 3 44.4%. Group 1 subjects were not followed beyond 12 months post booster; last recorded response was 52.8%. Immunogenicity in individuals 1 to 9 years of age: The immunogenicity of Trumenba (0-, 2- and 6-month schedule) in toddlers and children 1 to 9 years of age was evaluated in 2 Phase 2 studies. At 1 month following series completion, 81.4% to 100% of subjects achieved a defined hSBA titre threshold against the 4 primary meningococcal test strains (defined as hSBA ≥ 1:16 for A22; ≥ 1:8 for A56, B24 and B44) compared to 0.4% to 6.5% at baseline. Persistence data following primary series completion in toddlers 1 to < 2 years of age indicate that 12.4%, 59.1%, 10.3%, and 40.4% at 6 months and 3.7%, 22.8%, 3.7%, and 12.5% at 24 months after series completion maintained hSBA titres ≥ 1:8 or 1:16 against the primary test strains A22, A56, B24 and B44, respectively. An anamnestic response was observed when these children received a booster dose at approximately 24 months after primary series completion at 3 to 5 years of age, with 92.6% to 100.0% achieving hSBA titres ≥ 1:8 or 1:16 against the 4 primary strains. In children 2 to 9 years of age, 6 months following series completion, 32.5%, 82.4%, 15.5% and 10.4% of participants maintained hSBA titres ≥ 1:8 or 1:16 against primary test strains A22, A56, B24 and B44, respectively. There are no persistence data beyond 6 months or booster dose data in this age group.

Pregnancy and lactation: There are no data from the use of Trumenba in pregnant women. Vaccination during pregnancy/ lactation may be considered when the possible advantages outweigh the potential risk. Vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.

Undesirable effects: See SmPC for full details. In subjects 10 years of age and older, very common (³ 1/10) adverse events are headache, muscle pain (myalgia); joint pain (arthralgia), diarrhoea, nausea, chills, fatigue, redness (erythema), swelling (induration) and pain at injection site. Common (³ 1/100 to < 1/10) adverse events are vomiting and fever ≥ 38 °C (pyrexia). Allergic reactions have also been reported, frequency not known (cannot be estimated from the available data). Adverse reactions following booster vaccination in 301 subjects 15 to 23 years of age were similar to adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier. In a study of 294 children 2 to 9 years of age, the following adverse reactions occurred at a frequency of very common (≥ 1/10): headache, diarrhoea, vomiting, muscle pain, joint pain, fever, fatigue, and injection site pain, swelling and redness. Fever (≥ 38 °C) was reported in 24.5% of subjects. In a study of 220 toddlers 1 to < 2 years of age, the following adverse reactions occurred at a frequency of very common (≥ 1/10): drowsiness, irritability (fussiness), loss of or decreased appetite, fever, and injection site pain, swelling and redness. Fever (≥ 38 °C) was reported in 37.3% of subjects. In clinical studies, fever (≥ 38 °C) occurred more frequently as subject age decreased. Adverse reactions following a booster vaccination in 147 subjects 3 to 5 years of age were similar to adverse reactions during the primary Trumenba vaccination series approximately 2 years earlier. In a study including 115 infants 2 months and 48 infants 6 months of age who received Trumenba or an investigational combination meningococcal vaccine containing Trumenba co-administered with vaccines licensed for this age group, the following adverse reactions occurred at a frequency of very common (≥ 1/10): drowsiness, irritability (fussiness), loss of or decreased appetite, fever, and injection site pain, swelling and redness. Fever (≥ 38 °C) was reported in 74% of subjects, with 69% of subjects (33 out of 48) 6 months of age reporting fever and 76% of subjects (87 out of 115) 2 months of age. Occurrence of fever > 38.9 °C‑40.0 °C was very common (12.0-25.0%) in both age groups, despite the use of paracetamol. The study was terminated as two infants 2 months of age developed fever (39.3 °C and 39 °C, respectively) after the first vaccination that, despite the use of antipyretics, led to medical attention and investigations including lumbar puncture. Postmarketing data revealed 3 additional cases in which infants 1 to 3 months of age experienced fever leading to medical attention and investigations including lumbar puncture 1 day after administration of Trumenba.

Legal Category: S1A. Package Quantities: Pack of 1 single-dose pre-filled syringe (with separate needle). Marketing Authorisation Numbers: EU/1/17/1187/001. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at [email protected]. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500.

Date of preparation: 09/2024

Ref: TU 11_0