AS03B-adjuvanted H5N1 influenza vaccine in children 6 months through 17 years of age: a phase 2/3 randomized, placebo-controlled, observer-blinded trial.
Bottom Line: Within each age stratum, the lower limit of the 98.3% confidence interval for the day 42 seroprotection rate was ≥70%, thus fulfilling the US and European licensure criteria.The immune responses elicited by vaccine persisted well above baseline levels for 1 year.The vaccine was more reactogenic than placebo, but no major safety concerns were identified.
Affiliation: Department of Pediatrics, Khon Kaen University, Thailand.Show MeSH
Related in: MedlinePlus
Mentions: A total of 838 children were vaccinated, including 607 in the H5N1 vaccine group and 231 in the placebo group (Figure 1). For the total vaccinated cohort, the country distribution of enrolled subjects included 96 in Canada, 292 in Thailand, and 450 in the United States. An overview of the study cohorts and reasons for withdrawal is shown in Figure 1. The study groups were balanced for demographic characteristics at baseline (Table 1). The first child was enrolled on 7 March 2011, and the final contact (day 385) was on 4 July 2012. The safety database was closed on 13 September 2012.Table 1.
Affiliation: Department of Pediatrics, Khon Kaen University, Thailand.