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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 2,663 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05425732
The ClinicalTrials.gov registry entry for NCT05425732 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,663 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PCV20 is the first listed.
NCT05425732 reports 0 study locations.
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.
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