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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 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 2,200 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03486834
The ClinicalTrials.gov registry entry for NCT03486834 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,200 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 Placebo is the first listed.
NCT03486834 reports 0 study locations.
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.
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