Safety and Tolerability
The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows:1
- A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix. This total included 3,079 toddlers (12 months to 23 months), 909 children between 2 and 5 years of age, 990 children between 6 and 10 years of age, 2,317 adolescents (11 to 17 years) and 2,326 adults (18 to 55 years).
- Data from a study in infants aged 6 to 12 weeks at the time of the first dose (Study MenACWY-TT-083), 1,052 subjects received at least one dose of a primary series of 2 or 3 doses of Nimenrix and 1,008 received a booster dose at approximately 12 months of age.
Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was administered to 274 individuals aged 56 years and older.
Summary of adverse reactions by system organ class1
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)
- Hypersensitivity to the active substances or to any of the excipients
Warnings and precautions1
- Nimenrix® should not be administered intravascularly, intradermally or subcutaneously.
- Nimenrix® Summary of Product Characteristics.
Legal Category: S1A
PP-NIM-IRL-0020 Preparation Date July 2022