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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: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04168190 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 600 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (900% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.
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 |
What the finished NCT04168190 record still lists
NCT04168190 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (900% higher).
The record links to 0 conditions, and to 2 interventions - of which V116 is the first listed.
NCT04168190 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04168190's enrollment target sits among peer trials
600 27th of 2000 higher than 1,973 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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