A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

Summary

This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.

Timeline

Start

2022-09-23

Primary completion

2023-06-21

Completion

2023-06-21

Publications

• Results Omole T, Weinberg AS, Azizad M, Greenberg D, Grijalva CG, Orenstein WA, Euler D, Fernsler D, Park J, Li J, Platt HL; STRIDE-5 study group. A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older. Vaccine. 2025 Aug 30;62:127514. doi: 10.1016/j.vaccine.2025.127514. Epub 2025 Jul 25.

Drugs

Indications