Safety Tolerability and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)
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- STATUS
- Recruiting
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- End date
- May 14, 2021
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- participants needed
- 2100
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- sponsor
- Merck Sharp & Dohme Corp.
Toll Free Number
Primary Contact
Emerson Clinical Research Institute ( Site 0297) (4.6 mi away) Contact
+95 other locationSummary
This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus (CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women 16 to 35 years of age. Participants will receive 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 will be followed to approximately Month 36. The primary hypothesis of the study is that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.
Details
| Treatment | Placebo, V160 |
|---|---|
| Clinical Study Identifier | NCT03486834 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Last Modified on | 9 December 2020 |
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