CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,687 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.

Search/NCT00329745
NCT00329745Phase 3Completed
CompareCT.gov

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants.

GlaxoSmithKline·interventional·Posted May 25, 2006·Updated Dec 9, 2016

In Brief

A Phase 3 clinical trial evaluating Rotarix™ and Placebo for Infections, Rotavirus. Completed, enrolled 8,687 participants across 4 sites.

Detailed Summary

This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following schedules: at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or rota-030. 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
CountriesSingapore
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2006
Enrollment StartJan 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.1 years ago

Interventions

Rotarix™biological

Oral administration, 2 doses

Placebobiological

Oral administration, 2 doses