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NCT05420961 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 717
- Enrollment target
NCT05420961: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05420961 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 717 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05420961, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 717 participants
- Enrollment target
Study Summary
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Interventions
- BIOLOGICAL V116
- BIOLOGICAL PPSV23
- BIOLOGICAL PCV15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 717 participants |
| Start Date | 2022-07-12 |
| Est. Completion | 2023-05-16 |
| Phase | Phase 3 |
What the finished NCT05420961 record still lists
NCT05420961 is an interventional study that assigns participants to a tested intervention. The registered 717 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which V116 is the first listed.
NCT05420961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05420961 about?
NCT05420961 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)". This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
What is the current status of trial NCT05420961?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 717 participants. The study started on 2022-07-12. Estimated completion is 2023-05-16.
What interventions are being tested in trial NCT05420961?
The interventions under investigation include: V116 (BIOLOGICAL), PPSV23 (BIOLOGICAL), PCV15 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05420961?
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 NCT05420961's enrollment target sits among peer trials
717 498th of 2000 higher than 1,503 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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