At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,439 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.
Open, Multicentric, Post-marketing Surveillance Study to Evaluate Safety and Reactogenicity of GSK Bio's Live Attenuated Oral Human Rotavirus (HRV) Vaccine, Rotarix When Administered According to Prescribing Information, in Filipino Subjects Aged at Least 6 Weeks of Age at the Time of First Vaccination
In Brief
An observational study evaluating Rotarix and Data collection for Infections, Rotavirus and Rotavirus Vaccines. Completed, enrolled 1,439 participants across 18 sites.
Detailed Summary
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus, Rotavirus Vaccines
CountriesPhilippines
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2006
Enrollment StartNov 2006
Primary CompletionMar 2010
Study CompletionJul 2010
TodayJul 2026
First PostedJul 18, 2006
Enrollment StartNov 16, 2006
Primary CompletionMar 31, 2010
Study CompletionJul 17, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.0 years ago
Interventions
Rotarixbiological
Two doses of the oral vaccine
Data collectionother
Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.