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NCT05393037 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 313
- Enrollment target
NCT05393037: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05393037 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 313 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05393037, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 313 participants
- Enrollment target
Study Summary
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.
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. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL V116
- BIOLOGICAL PPSV23
- BIOLOGICAL PCV15
- BIOLOGICAL PCV15 - Part B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2024-01-25 |
| Phase | Phase 3 |
What the finished NCT05393037 record still lists
NCT05393037 is an interventional study that assigns participants to a tested intervention. The registered 313 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 (59% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT05393037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05393037 about?
NCT05393037 is a clinical study titled "Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)". This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.
What is the current status of trial NCT05393037?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 313 participants. The study started on 2022-07-13. Estimated completion is 2024-01-25.
What interventions are being tested in trial NCT05393037?
The interventions under investigation include: Placebo (BIOLOGICAL), V116 (BIOLOGICAL), PPSV23 (BIOLOGICAL), PCV15 (BIOLOGICAL), PCV15 - Part B (BIOLOGICAL).
Who is sponsoring clinical trial NCT05393037?
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 NCT05393037's enrollment target sits among peer trials
313 1101st of 2000 higher than 899 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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