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NCT03480763 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 652
- Enrollment target
NCT03480763: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03480763 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 652 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03480763, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 652 participants
- Enrollment target
Study Summary
This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.
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 treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Interventions
- BIOLOGICAL V114
- BIOLOGICAL Prevnar 13™
- BIOLOGICAL PNEUMOVAX™23
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 652 participants |
| Start Date | 2018-06-22 |
| Est. Completion | 2019-12-23 |
| Phase | Phase 3 |
What the finished NCT03480763 record still lists
NCT03480763 is an interventional study that assigns participants to a tested intervention. The registered 652 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 (16% lower).
The record links to 0 conditions, and to 3 interventions - of which V114 is the first listed.
NCT03480763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03480763 about?
NCT03480763 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)". This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUM...
What is the current status of trial NCT03480763?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2018-06-22. Estimated completion is 2019-12-23.
What interventions are being tested in trial NCT03480763?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL), PNEUMOVAX™23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03480763?
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 NCT03480763's enrollment target sits among peer trials
652 571st of 2000 higher than 1,429 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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