Nimenrix Adverse Reactions

The safety profile presented in Table 19 is based on two data sets: A pooled analysis in more than 9,000 subjects from the age of 1 year on, who have been vaccinated with 1 dose of Nimenrix in clinical studies.
Data from approximately 1,000 infants (6 weeks to 12 months of age) who have been primed and boosted with Nimenrix. (See Table 19.)

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In a separate study a single dose of Nimenrix was administered to 274 individuals aged 56 years and older. All adverse reactions reported in this study were already observed in younger age groups.
Local and general adverse reactions: In all age groups, the local adverse reactions of pain, redness and swelling at the injection site were reported at a very common frequency after vaccination.
In the infant and toddler groups, the general adverse reactions of drowsiness, fever, irritability/fussiness and loss of appetite were reported at a very common frequency after vaccination.
In a separate infant study, 554 infants were primed with one or three doses of Nimenrix and 508 received booster doses in the second year of life. Local and general adverse reactions in this study were similar in frequency to the larger infant study.
In the 12-14 months age group who received two doses of Nimenrix given two months apart, the first and second doses were associated with similar local and systemic reactogenicity.
In an additional clinical study of age-matched subjects who were either healthy or at increased risk of meningococcal disease due to anatomical or functional asplenia (such as sickle cell disease), the safety profile of Nimenrix in at-risk children and adolescents was generally similar to that observed in the non-asplenic population (see Pharmacology: Pharmacodynamics under Actions).
The 2-5 year group reported general adverse reactions at a frequency ranging from common (irritability, loss of appetite and fever) to very common (drowsiness).
In the 6-10, 11-17 and ≥18 years age groups, the general adverse reactions were reported at a frequency ranging from common (gastrointestinal symptoms and fever) to very common (headache and fatigue).
In a clinical study of 11 to 25 year old subjects co-administered Nimenrix and Tdap or given the vaccines separately, the local reactions (injection site pain, redness, and swelling) and general reactions (fatigue and headache) occurred at a similar frequency in both groups and in the subjects in the pooled analysis (very common). The general reactions gastrointestinal events (nausea, vomiting, diarrhoea, abdominal pain) occurred more frequently (very common) and fever occurred less frequently (common) compared to subjects in the pooled analysis, but occurred at a similar frequency in subjects co-administered the vaccines and subjects given the vaccines separately in the study.
In a clinical study of female subjects 9 to 25 years old, the local reactions (pain, redness, and swelling at the Nimenrix injection site) and general reactions (headache, fever, and fatigue) occurred at a similar frequency in subjects co-administered Nimenrix, Tdap and HPV2 and in subjects given Nimenrix alone, as they did in subjects in the pooled analysis (very common). The general reactions gastrointestinal events (nausea, vomiting, diarrhoea, abdominal pain) and myalgia occurred at a similar frequency in the two groups but more frequently than in the pooled analysis (very common), as did the general reaction rash (common).
The local and general adverse reaction profile of a booster dose of Nimenrix given to subjects from 12 months of age after primary vaccination with Nimenrix or other conjugated or plain polysaccharide meningococcal vaccines, was similar to the local and general adverse reaction profile observed after primary vaccination with Nimenrix, except gastrointestinal symptoms (including diarrhoea, vomiting, and nausea) which ranged from common to very common among subjects 6 years of age and older (versus common after primary vaccination).