Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

Summary

The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.

Timeline

Start

2023-02-13

Primary completion

2024-02-16

Completion

2024-02-16

Publications

• Results Scott PT, Pathirana J, Kato A, Tytus R, Perez CM, Gilchrist NL, Kanou H, Ha Yoo K, Kania G, Nissen M, Russell AF, Fernsler D, Waleed M, Li J, Buchwald UK, Platt HL. A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naive Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8. Clin Infect Dis. 2026 Feb 25;82(2):e217-e226. doi: 10.1093/cid/ciaf604.

Drugs

Indications