CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 765 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/NCT00480324
NCT00480324Phase 3Completed
CompareCT.gov

Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants

GlaxoSmithKline·interventional·Posted May 30, 2007·Updated Jan 2, 2020

In Brief

A Phase 3 clinical trial evaluating Rotarix and Placebo for Infections, Rotavirus and Rotavirus Vaccines. Completed, enrolled 765 participants across 20 sites.

Detailed Summary

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus \[HRV\] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. 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, Rotavirus Vaccines
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2007
Enrollment StartJun 19, 2007
Primary CompletionMar 31, 2009
Study CompletionNov 21, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.1 years ago

Interventions

Rotarixbiological

Two-dose oral vaccination.

Placebobiological

Two-dose oral administration.