CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
rotavirus vaccine +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.

Search/NCT00981669
NCT00981669Phase 1Completed
CompareCT.gov

Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation

Butantan Institute·interventional·Posted Sep 22, 2009·Updated Apr 25, 2013

In Brief

A Phase 1 clinical trial evaluating rotavirus vaccine and placebo for Rotavirus Infections. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus Infections
CountriesBrazil
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2009
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.8 years ago

Interventions

rotavirus vaccinebiological

3 doses with 6 weeks interval

placebobiological

3 doses with 6 weeks interval