RANDOMIZED, DOUBLE-BLIND, PHASE III, PIVOTAL FIELD TRIAL OF THE COMPARATIVE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF TWO YELLOW FEVER 17D VACCINES (ARILVAXTM AND YF-VAX(R)) IN HEALTHY INFANTS AND CHILDREN IN PERU.

摘要

We conducted a randomized, double-blind, phase III yellow fever (YF) vaccine trial among 1,107 healthy children in Sullana in northern Peru. The safety and efficacy (by measurement of geometric mean neutralizing antibody titer responses) were determined for two YF vaccines, ARILVAXtrade mark (n = 738) and YF-VAX(R) (n = 369). Serocon-version rates were higher (94.9%) in ARILVAXtrade mark than in YF-VAX(R) (90.6%) recipients. The two-sided 95% confidence interval (YF-VAX(R)-ARILVAXtrade mark) was (-12.8% to -2.5%), indicating that the higher seroconversion rate for Arilvaxtrade mark was significant. Post-vaccination (30-day) mean log(10) neutralization indices were found to be similar for both products: 1.32 for ARILVAXtrade mark and 1.26 for YF-VAX(R) (P = 0.1404, by analysis of variance). A similar number of subjects in each group reported at least one adverse event (AE); 441 (59.8%) for ARILVAXtrade mark versus 211 (59.9%) for YF-VAX(R). Most (591; 96.7%) of these were of a mild nature and resolved without treatment. There were no treatment-related serious AEs. This is the first randomized, double-blind comparison of two YF vaccines in a pediatric population; both vaccines were shown to be highly immunogenic and well-tolerated.