CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,613 enrolled
Drug / intervention
Rotarix (primary vaccination study) +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/NCT00420316
NCT00420316Phase 3Completed
CompareCT.gov

To Assess Long-term Efficacy & Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in the Primary Vaccination Study (102247).

GlaxoSmithKline·interventional·Posted Jan 11, 2007·Updated Aug 28, 2018

In Brief

A Phase 3 clinical trial evaluating Rotarix (primary vaccination study) and Placebo (primary vaccination study) for Infections, Rotavirus. Completed, enrolled 1,613 participants across 15 sites.

Detailed Summary

To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesFinland
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2007
Enrollment StartFeb 12, 2007
Primary CompletionAug 8, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.5 years ago

Interventions

Rotarix (primary vaccination study)biological

GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.

Placebo (primary vaccination study)biological

Two liquid oral doses of placebo