At a glance
ClinicalIndex Comparison RecordN/ACompleted· 522 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.
Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.
In Brief
An observational study evaluating Rotarix™ for Infections, Rotavirus. Completed, enrolled 522 participants across 1 site.
Detailed Summary
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesSri Lanka
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartNov 2008
Primary CompletionMay 2009
Study CompletionAug 2009
TodayJul 2026
First PostedOct 24, 2008
Enrollment StartNov 22, 2008
Primary CompletionMay 25, 2009
Study CompletionAug 26, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.7 years ago
Interventions
Rotarix™biological
Two oral doses, with at least 4 weeks interval in-between