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NCT05696080 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
NCT05696080: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05696080 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 518 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05696080, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
Study 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.
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. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL V116
- BIOLOGICAL PPSV23
- BIOLOGICAL PCV15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2023-02-13 |
| Est. Completion | 2024-02-16 |
| Phase | Phase 3 |
What the finished NCT05696080 record still lists
NCT05696080 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05696080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05696080 about?
NCT05696080 is a clinical study titled "Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)". 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 serot...
What is the current status of trial NCT05696080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2023-02-13. Estimated completion is 2024-02-16.
What interventions are being tested in trial NCT05696080?
The interventions under investigation include: Placebo (BIOLOGICAL), V116 (BIOLOGICAL), PPSV23 (BIOLOGICAL), PCV15 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05696080?
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 NCT05696080's enrollment target sits among peer trials
518 723rd of 2000 higher than 1,277 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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