185 = the number needed to vaccinate (NNV) to prevent one case of hospital-diagnosed pneumonia during 2 years of follow-up‡ 3
* Double-blind study in healthy infants aged 6 to 16 weeks who were randomized to SYNFLORIX or hepatitis B control vaccine at 2, 4 and 6 months of age followed respectively by either SYNFLORIX or hepatitis A control vaccine at 15 to 18 months of age. The ATP cohort was defined as the group of participants immunized with at least the 3-dose primary series. For the interim analysis (IA, which contained the final analysis of the event-driven primary objective), the median follow-up duration was 24.3 months (1st quartile 19.9 months, 3rd quartile 28.4 months) from 2 weeks post-dose 3 in the ATP cohort. Likely bacterial CAP defined as radiologically-confirmed CAP cases with either alveolar consolidation/pleural effusion on the chest X-ray, or with non-alveolar infiltrates but with C-reactive protein ≥40 mg/L.
† CI value: Type I error not adjusted for the interim analysis. P-value: Adjusted one-side alpha value of 1.75%.
‡ Double-blind, cluster-randomized, controlled study in Finland in which children were randomized into 4 groups according to the 2 infant vaccination schedules [2-dose, N=10,054 (3, 5 months of age) or 3-dose, N=10,273 (3, 4, 5 months of age) primary schedule followed by a booster dose as of 11 months of age] to receive either SYNFLORIX (2/3 of clusters) or hepatitis vaccines as control (1/3 of clusters, N=10,200). In the catch-up cohorts, children between 7-11 months of age at first dose received 2 doses of either SYNFLORIX or hepatitis B control vaccine followed by a booster, and children between 12-18 months of age at first dose received 2 doses of either SYNFLORIX or hepatitis A control vaccine. Average follow-up, from first vaccination, was 24 to 28 months for invasive disease, hospital-diagnosed pneumonia and outpatient antimicrobial prescriptions.