CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,111 enrolled
Drug / intervention
Rotarix or Rotarix liquid formulationbiological
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/NCT00750893
NCT00750893N/ACompleted
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Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix or Rotarix Liquid Formulation (Oral Suspension or Prefilled Syringe) When Administered According to the Prescribing Information in Korea

GlaxoSmithKline·observational·Posted Sep 11, 2008·Updated Mar 3, 2020

In Brief

An observational study evaluating Rotarix or Rotarix liquid formulation for Infections, Rotavirus. Completed, enrolled 3,111 participants across 1 site.

Detailed Summary

This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2008
Enrollment StartSep 2, 2008
Primary CompletionJun 15, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.8 years ago

Interventions

Rotarix or Rotarix liquid formulationbiological

GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe).