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NCT03486834 · ClinicalTrials.gov registry record · Phase 2
V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,200
- Enrollment target
NCT03486834: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT03486834 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 2,200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1554% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03486834, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,200 participants
- Enrollment target
Study Summary
This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.
Primary Outcome
Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). T
Interventions
- DRUG Placebo
- BIOLOGICAL V160
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,200 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 2 |
What the finished NCT03486834 record still lists
NCT03486834 is an interventional study that assigns participants to a tested intervention. Its 2,200 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1554% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03486834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03486834 about?
NCT03486834 is a clinical study titled "V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)". This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 an...
What is the current status of trial NCT03486834?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,200 participants. The study started on 2018-04-30. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03486834?
The interventions under investigation include: Placebo (DRUG), V160 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03486834?
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 NCT03486834's enrollment target sits among peer trials
2,200 8th of 2000 higher than 1,993 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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