Comprehensive Assessment of Reactogenicity and Safety of the Live-Attenuated Chikungunya Vaccine (IXCHIQ^®).

ABSTRACT: Background/Objectives: This overview provides a comprehensive safety evaluation of the approved live-attenuated vaccine VLA1553 (IXCHIQ^®) for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in clinical trials. Methods: Protocol-defined solicited systemic events (i.e., fever, arthralgia, myalgia, fatigue, and headache) and other unsolicited arthralgia-related events were evaluated. Additionally, during a regulatory review, a broader definition of adverse events of special interest (broad-definition AESIs) (fever and ≥1 AESI symptom within 30 days post-vaccination) was evaluated post hoc. Results: The most frequently reported solicited systemic events post-VLA1553 included fever (13.5%), arthralgia (17.2%), myalgia (23.9%)

SUBMITTER: Maurer G 

PROVIDER: S-EPMC12197765 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature