At a glance
ClinicalIndex Comparison RecordN/ACompleted· 332 enrolled
Drug / intervention
Rotarix™biological
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.
Post Marketing Surveillance to Monitor the Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered According to the Prescribing Information to Indian Infants
In Brief
An observational study evaluating Rotarix™ for Infections, Rotavirus. Completed, enrolled 332 participants across 12 sites.
Detailed Summary
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesIndia
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartAug 2009
Primary CompletionFeb 2010
Study CompletionApr 2010
TodayJul 2026
First PostedJul 13, 2009
Enrollment StartAug 3, 2009
Primary CompletionFeb 20, 2010
Study CompletionApr 23, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.0 years ago
Interventions
Rotarix™biological
Two doses of oral vaccine.