Trials / Completed
CompletedNCT03840174
Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)
A Phase I Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of V160 (Human Cytomegalovirus Vaccine) in Healthy Japanese Men
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Male
- Age
- 20 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V160 | V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA) |
| OTHER | Placebo | Saline solution (0.9% sodium chloride \[NaCl\] administered as a 0.5 mL IM injection |
Timeline
- Start date
- 2019-03-08
- Primary completion
- 2019-11-07
- Completion
- 2019-11-07
- First posted
- 2019-02-15
- Last updated
- 2023-05-06
- Results posted
- 2021-11-15
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03840174. Inclusion in this directory is not an endorsement.