Comparison of US inactivated split-virus and Russian live attenuated, cold-adapted trivalent influenza vaccines in Russian schoolchildren.

In a blinded, placebo-controlled study, the reactogenicity, immunogenicity, and clinical efficacy of single doses of US inactivated split-virus and Russian live attenuated, cold-adapted influenza vaccines were compared in 555 schoolchildren in Vologda, Russia. Serial serum samples were collected and school absenteeism was assessed. Systemic reactions were rare, but local reactions (primarily erythema at the injection site) were observed in 27% of the inactivated vaccine group, and coryza (12%) and sore throat (8%) were observed in the attenuated vaccine group. At 4 weeks after vaccination a > or = 4-fold rise in titer of hemagglutination inhibition antibody to A (H1N1), A (H3N2), and B was noted, respectively, among 78%, 88%, and 53% of children who received inactivated vaccine and among 55%, 79%, and 30% of children who received attenuated vaccine. The vaccine efficacy for preventing school absenteeism due to respiratory illness during the period of peak influenza activity was 56% for inactivated vaccine and 47% for attenuated vaccine.

RCT Entities:   Population Interventions Outcomes