Summary of the safety profile The safety profile presented is based on analysis of approximately 17,000 subjects (1 year of age and older) who have been vaccinated with at least 1 dose of Trumenba in completed clinical studies. In over 16,000 subjects ≥ 10 years of age studied, the most common adverse reactions were headache, diarrhoea, nausea, muscle pain, joint pain, fatigue, chills, and injection site pain, swelling and redness.
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. List of adverse reactions Adverse reactions reported in clinical studies of subjects 10 years of age and older are listed in decreasing order of frequency and seriousness.
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) Immune system disorders Not known: Allergic reactions* Nervous system disorders Very Common: Headache Gastrointestinal disorders Very Common: Diarrhoea; nausea Common: Vomiting Musculoskeletal and connective tissue disorders Very Common: Muscle pain (myalgia); joint pain (arthralgia) 6 General disorders and administration site conditions Very Common: Chills; fatigue; redness (erythema), swelling (induration) and pain at injection site Common: Fever ≥ 38 °C (pyrexia) *Reported in the postmarketing experience.
Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known. Paediatric population < 10 years of age Children/toddlers 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.
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.
3% of subjects. In clinical studies, fever (≥ 38 °C) occurred more frequently as subject age decreased. Fever followed a predictable pattern after vaccination: onset occurred within 2 to 4 days, lasted 1 day, and was mild to moderate in severity.
Fever rate and severity tended to decrease with subsequent Trumenba vaccinations. Booster vaccination in children 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.
Infants less than 1 year of age 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. 0%) in both age groups, despite the use of paracetamol. The rate and severity of fever did not decrease with the second vaccination in the youngest infants.
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. Cerebrospinal fluid (CSF) analysis showed pleocytosis without positive microbiological test results in 1 infant.
Both cases were treated as presumed infections. Symptoms resolved for both infants. 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.
CSF analysis showed no pleocytosis in 2 cases and in 1 case showed pleocytosis without a positive microbiological test result. 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 national reporting system listed in Appendix V. 7