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NCT05526716 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,080
- Enrollment target
NCT05526716: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05526716 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,080 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05526716, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,080 participants
- Enrollment target
Study Summary
This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.
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. Solicited injection-site AEs included erythema, pain, and swelling.
Interventions
- BIOLOGICAL QIV
- BIOLOGICAL V116
- BIOLOGICAL Matching Placebo for V116
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,080 participants |
| Start Date | 2022-09-23 |
| Est. Completion | 2023-06-21 |
| Phase | Phase 3 |
What the finished NCT05526716 record still lists
NCT05526716 is an interventional study that assigns participants to a tested intervention. Its 1,080 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 (40% higher).
The record links to 0 conditions, and to 3 interventions - of which QIV is the first listed.
NCT05526716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05526716 about?
NCT05526716 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)". This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 adminis...
What is the current status of trial NCT05526716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,080 participants. The study started on 2022-09-23. Estimated completion is 2023-06-21.
What interventions are being tested in trial NCT05526716?
The interventions under investigation include: QIV (BIOLOGICAL), V116 (BIOLOGICAL), Matching Placebo for V116 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05526716?
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 NCT05526716's enrollment target sits among peer trials
1,080 269th of 2000 higher than 1,731 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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