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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 652 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03480763
The ClinicalTrials.gov registry entry for NCT03480763 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 652 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 V114 is the first listed.
NCT03480763 reports 0 study locations.
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.
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