At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 29 enrolled
Drug / intervention
Rotavindrug
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 1 Study to Evaluate Safety and Reactogenicity of a Vietnamese Rotavirus Vaccine (Rotavin-M1 at 10e6.3FFU/Dose) Among Healthy Adults in Vietnam
National Institute of Hygiene and Epidemiology, Vietnam·interventional·Posted Jun 17, 2011·Updated Jul 4, 2016
In Brief
A Phase 1 clinical trial evaluating Rotavin for Diarrhea and 4 related conditions. Completed, enrolled 29 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea, Vomit, Fever, Nausea, Irritability
CountriesVietnam
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
Primary CompletionOct 2009
First PostedJun 2011
TodayJul 2026
First PostedJun 17, 2011
Enrollment StartAug 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.0 years ago
Interventions
Rotavindrug
Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses