Lastly, results of TIV-controlled studies by influenza type and subtype were not explored by Rhorer et al. The objective of this analysis was to evaluate the efficacy of LAIV in children 2–17 years of age overall and by type/subtype, including the effects Selleckchem E7080 of various subject characteristics, using data from all available randomized controlled trials. This is the first meta-analysis conducted for children 2–17 years of age, the age group for whom LAIV is approved for use. Of the 9 randomized, controlled trials evaluating the efficacy of LAIV against culture-confirmed influenza in children, one was conducted exclusively in children younger than 24 months and was excluded
from analysis. Of the remaining 8 trials that enrolled children 2–17 years of age, 5 compared LAIV with placebo, of which 4 evaluated children vaccinated for 2 consecutive influenza seasons (Table 1) [9], [11], [12], [13], [14] and [15]. Placebo-controlled trials enrolled children in year 1 who had not been previously vaccinated against influenza. Three trials compared LAIV with TIV (Table 1) [16], [17] and [18] over a single influenza
season. These trials enrolled children regardless of previous influenza vaccination. In the Ashkenazi et al. study, all subjects received 2 doses of vaccine, while in the Fleming et al. study, all subjects received a single dose of vaccine [16] and [18]. In the study by Belshe et al., previously unvaccinated children received 2 doses of vaccine, while previously vaccinated children were administered a single dose of vaccine [17]. All previous analyses of the studies in question have shown that efficacy results Tryptophan synthase were similar
PD0332991 cell line for the per-protocol and intent-to-treat populations. Accordingly, the current analysis was limited to the per-protocol population of children ≥24 months of age at vaccination. Efficacy in year 1 was measured for children ≥24 months of age at enrollment; efficacy in year 2 was measured for children ≥24 months of age at year 2 vaccination. The prespecified endpoints of interest were efficacy relative to placebo and TIV against culture-confirmed influenza illness caused by antigenically similar strains and all strains regardless of antigenic match. Dosing regimens inconsistent with the recommended use of LAIV (e.g. low titer formulations or use of a single dose in previously unvaccinated children) were not examined. Predefined subgroup analyses included efficacy by influenza type/subtype (A/H3N2, AH1N1, B), by gender, and by region. Classification of drifted, antigenic variant influenza B viruses varied across trials, with some classifying them as antigenically similar and others classifying them as antigenically dissimilar [20]. In the current analysis, illnesses caused by drifted influenza B viruses were analyzed as originally classified by the trials and secondarily by classifying all antigenic variants of B viruses as dissimilar.
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