At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 799 enrolled
Drug / intervention
Rotavin-M1 +1 morebiological
Likely dose
Not stated in 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 2b Study of Rotavin-M1 Vaccine in Vietnamese Children
National Institute of Hygiene and Epidemiology, Vietnam·interventional·Posted Jan 2, 2012·Updated Jan 2, 2012
In Brief
A Phase 3 clinical trial evaluating Rotavin-M1 and cell culture medium in absence of virus for Diarrhea and 4 related conditions. Completed, enrolled 799 participants across 2 sites.
Detailed Summary
This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of Vaccines and Biologicals, Vietnam.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea, Fever, Nausea, Vomit, Irritability
CountriesVietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
Primary CompletionSep 2011
Study CompletionOct 2011
First PostedJan 2012
TodayJul 2026
First PostedJan 2, 2012
Enrollment StartMay 1, 2010
Primary CompletionSep 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.5 years ago
Interventions
Rotavin-M1biological
liquid, 10e6ffu/dose, 2 doses, 2 month interval
cell culture medium in absence of virusbiological
Placebo