At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
Rotarix +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 IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
In Brief
A Phase 3 clinical trial evaluating Rotarix and Placebo for Infections, Rotavirus. Completed, enrolled 200 participants across 1 site.
Detailed Summary
The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesDominican Republic
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2006
Enrollment StartJan 2007
Primary CompletionJan 2008
Study CompletionFeb 2008
TodayJul 2026
First PostedNov 7, 2006
Enrollment StartJan 23, 2007
Primary CompletionJan 23, 2008
Study CompletionFeb 13, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.7 years ago
Interventions
Rotarixbiological
Two-dose oral vaccination.
Placebobiological
Two-dose oral administration.