Efficacy Study With QIVc in Pediatric Subjects

Summary

This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

Timeline

Start

2019-05-13

Primary completion

2023-11-30

Completion

2024-02-13

Publications

• Poder A, Ong-Lim AL, Rivera Medina DM, Zaman K, Makedonska I, de Bruijn M, Matassa V, Fortanier AC, Heijnen E, Hohenboken M, Molrine DC. Efficacy, immunogenicity, and safety of a cell culture-derived quadrivalent influenza vaccine compared with a non-influenza vaccine in infants and children across five influenza seasons: a phase 3, multinational, observer-blind, randomised controlled trial. Lancet Child Adolesc Health. 2026 May;10(5):352-363. doi: 10.1016/S2352-4642(26)00009-X.

Drugs

Indications