At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
V160 +1 morebiological
Likely dose
V160 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating V160 and Placebo for Cytomegalovirus Infections. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Infections
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartMar 2019
Primary CompletionNov 2019
TodayJul 2026
First PostedFeb 15, 2019
Enrollment StartMar 8, 2019
Primary CompletionNov 7, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.4 years ago
Interventions
V160biological
V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA)
Placeboother
Saline solution (0.9% sodium chloride \[NaCl\] administered as a 0.5 mL IM injection