Clinical endpoints to inform vaccine policy: A systematic review of outcome measures from pediatric influenza vaccine efficacy trials.

Introduction: We conducted a systematic review of pediatric influenza vaccine efficacy trials to assess clinical outcome measures and whether the trials defined important public health endpoints.

Material And Methods: We systematically identified phase 3 or 4 influenza vaccine randomized controlled trials among children ≤18 years of age with laboratory-confirmed influenza outcomes since 1980. We recorded countries, age groups, vaccine formulations, specimen collection criteria, laboratory diagnostics, primary and secondary outcome measures, and funders, and we determined income category for study countries.