A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years

Summary

This is a multicenter, prospective, randomized, observer-blinded, three arm, phase 2 clinical trial evaluating the full dose formulation of VLA1553, half dose formulation of VLA1553 and control. At least 300 male and female healthy children aged 1 to 11 years will be enrolled and the overall distribution of participants will be 2:2:1 to the two VLA1553 dose groups (n=120 each) or control (n=60).

Timeline

Start

2023-12-18

Primary completion

2024-07-31

Completion

2025-07-02

Publications

• Weisova P, Scheiblauer S, Ecker J, Schneider M, Hochreiter R, Bitzer A, Kosulin K, Schoengrundner P, Fuchs U, Rodeles L, Mazara S, Donastorg Y, Rivera S, Wressnigg N, Dubischar K, Buerger V, Eder-Lingelbach S, Jaramillo JC. Live-attenuated chikungunya vaccine in children: a randomized phase 2 trial. Nat Med. 2026 Feb;32(2):561-571. doi: 10.1038/s41591-025-04197-2. Epub 2026 Feb 6.

Drugs

Indications