Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)
Summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
Timeline
- Start
- 2023-01-10
- Primary completion
- 2023-05-24
- Completion
- 2023-05-24
Outcome
Met primary endpoint
paper V116 was non-inferior compared with PPSV23 for the 12 common serotypes and for the cross-reactive serotype 15B. PMID 40763490 ↗
paper V116 was superior compared with PPSV23 for the nine unique serotypes (including serotype 15C). PMID 40763490 ↗
release “STRIDE-9試験（ NCT05633992 ）は、肺炎球菌ワクチン接種歴のない65歳以上の日本人（n=450）を対象としてV116を評価する第3相無作為化二重盲検実薬対照比較試験です。血清型特異的OPA応答をベースラインと接種後30日目に測定したところ、V116はPPSV23と共通の12種類の血清型と、15B（PPSV23に含まれておりV116には含まれていない）について免疫応答の非劣性を示しました。” msd.co.jp ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | PPSV23 | Vaccine | 25 ug | Intramuscular |
| Subject | V116 | Vaccine | 4 ug | Intramuscular |