Mapping Pediatric Seasonal Influenza Vaccine Safety and Immunogenicity Evidence: A Systematic Review of Clinical Trials.

ABSTRACT: Background: Influenza poses a significant health threat to children under nine, who are at high risk of severe complications. Influenza vaccination is a key prevention strategy, but pediatric trials use heterogeneous safety and immunogenicity outcomes, follow-up windows, and dosing strata that hinder meaningful cross-trial comparison. Objective: To map how safety and immunogenicity outcomes are defined, collected, stratified, and reported across clinical trials of seasonal influenza vaccines in healthy children aged 6 months to 8 years, and to identify reporting patterns and gaps that limit cross-trial comparability. Methods: Studies were identified through a structured PubMed/MEDLINE search first conducted 20 April 2025 and last conducted June 2025, following JBI and

SUBMITTER: Munoz A 

PROVIDER: S-EPMC12846517 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature