Clinical trials involved the administration of approximately 64,000 doses of Synflorix to approximately 22,500 healthy children and 137 preterm infants as primary vaccination. Approximately 19,500 healthy children and 116 preterm infants received a booster dose of Synflorix in the second year of life. Safety was also assessed in approximately 400 children from 2 to 5 years old. In all trials, Synflorix was administered concurrently with the recommended childhood vaccines.
No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the primary vaccination series.
Reactogenicity was higher in children receiving whole cell pertussis vaccines concomitantly.
Adverse reactions reported (for all age groups) are listed according to the following frequency: 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. (See Table 4.)
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Safety of Synflorix was assessed in 83 HIV positive infants, 101 HIV negative infants born from an HIV positive mother and 150 children with SCD. Results suggest comparable reactogenicity and safety profile of Synflorix between these high risk groups and healthy children.