At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,340 enrolled
Drug / intervention
GSK Biologicals' liquid human rotavirus vaccine 444563 +3 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.
Efficacy, Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals' liquid human rotavirus vaccine 444563, Placebo, and 2 other interventions for Infections, Rotavirus. Completed, enrolled 3,340 participants across 4 sites.
Detailed Summary
The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartAug 2010
Primary CompletionMay 2012
TodayJul 2026
First PostedJul 29, 2010
Enrollment StartAug 29, 2010
Primary CompletionMay 12, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.9 years ago
Interventions
GSK Biologicals' liquid human rotavirus vaccine 444563biological
Oral administration
Placebobiological
Oral administration
Infanrix™biological
Intramuscular administration
Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)biological
Oral administration