Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04168190 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 600
- Enrollment target
NCT04168190 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 600 participants.
The verdict
NCT04168190, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 600 participants
- Enrollment target
Study Summary
This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.
Interventions
- BIOLOGICAL V116
- BIOLOGICAL Pneumovax™23
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2019-12-06 |
| Est. Completion | 2021-07-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04168190
The ClinicalTrials.gov registry entry for NCT04168190 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 600 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 2 interventions - of which V116 is the first listed.
NCT04168190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04168190 about?
NCT04168190 is a clinical study titled "A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)". This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (...
What is the current status of trial NCT04168190?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2019-12-06. Estimated completion is 2021-07-12.
What interventions are being tested in trial NCT04168190?
The interventions under investigation include: V116 (BIOLOGICAL), Pneumovax™23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04168190?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.