Phase 3 Trial Evaluates Safety and Immunogenicity of CHIKV VLP Vaccine in Children

This ongoing Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of the CHIKV VLP vaccine in children aged 1 to <12 years. The study aims to enroll 720 participants and is sponsored by Bavarian Nordic. The primary immunogenicity endpoint is the seroresponse rate on Day 22 in seronegative children, while safety endpoints include the incidence of adverse events of special interest (AESI), medically attended adverse events (MAAEs), and serious adverse events (SAEs). Additionally, the study monitors unsolicited adverse events through Day 29. The trial's primary completion is anticipated by December 2028. The results will provide critical insights into the vaccine's potential to protect children against the chikungunya virus, with safety and immunogenicity being key measures of success.