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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,080 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05526716
The ClinicalTrials.gov registry entry for NCT05526716 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,080 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 3 interventions - of which QIV is the first listed.
NCT05526716 reports 0 study locations.
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.
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