At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 200 enrolled
Drug / intervention
Rotarixbiological
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 II, Randomized, Double-blind, Vaccine-controlled Dose-escalating Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotavin-M1) in Healthy Infants in Vietnam
National Institute of Hygiene and Epidemiology, Vietnam·interventional·Posted Jun 21, 2011·Updated Jul 4, 2016
In Brief
A Phase 2 clinical trial evaluating Rotarix for Diarrhea and 4 related conditions. Completed, enrolled 200 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam. In addition, we evaluate different dosages and schedules to determine the best regimen to test in a clinical trial.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea, Fever, Nausea, Vomit, Irritability
CountriesVietnam
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
Primary CompletionMar 2010
Study CompletionApr 2010
First PostedJun 2011
TodayJul 2026
First PostedJun 21, 2011
Enrollment StartOct 1, 2009
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.0 years ago
Interventions
Rotarixbiological
2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses