Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age

Summary

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the safety, tolerability, and immunogenicity of 3 lots of RSVpreF in healthy adults.

Timeline

Start

2021-10-21

Primary completion

2022-04-04

Completion

2022-04-04

Outcome

Met primary endpoint

paper All 3 RSVpreF lots elicited strong immune responses, meeting the 1.5-fold equivalence criterion for all between-lot comparisons for both RSV A and RSV B. PMID 38616438 ↗

Publications

• Baker J, Aliabadi N, Munjal I, Jiang Q, Feng Y, Brock LG, Cooper D, Anderson AS, Swanson KA, Gruber WC, Gurtman A. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study. Vaccine. 2024 May 10;42(13):3172-3179. doi: 10.1016/j.vaccine.2024.03.070. Epub 2024 Apr 16.

Drugs

Indications