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NCT05425732 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,663
- Enrollment target
NCT05425732: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05425732 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 2,663 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (245% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05425732, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,663 participants
- Enrollment target
Study Summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\[Prevnar 20™ / APEXXNAR™\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.
Interventions
- BIOLOGICAL PCV20
- BIOLOGICAL V116
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,663 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2023-05-18 |
| Phase | Phase 3 |
What the finished NCT05425732 record still lists
NCT05425732 is an interventional study that assigns participants to a tested intervention. Its 2,663 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (245% higher).
The record links to 0 conditions, and to 2 interventions - of which PCV20 is the first listed.
NCT05425732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05425732 about?
NCT05425732 is a clinical study titled "Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)". This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\[Prevnar 20™ / APEXXNAR™\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noni...
What is the current status of trial NCT05425732?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,663 participants. The study started on 2022-07-13. Estimated completion is 2023-05-18.
What interventions are being tested in trial NCT05425732?
The interventions under investigation include: PCV20 (BIOLOGICAL), V116 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05425732?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05425732's enrollment target sits among peer trials
2,663 84th of 2000 higher than 1,917 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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