At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
Synflorix™( GSK1024850A) +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.
Primary Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, in Healthy Infants in Vietnam When Co-administered With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
In Brief
A Phase 3 clinical trial evaluating Synflorix™( GSK1024850A) and Infanrix hexa™ for Infections, Streptococcal and Streptococcus Pneumoniae Vaccines. Completed, enrolled 300 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesVietnam
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartFeb 2011
Primary CompletionJul 2011
TodayJul 2026
First PostedJun 30, 2010
Enrollment StartFeb 17, 2011
Primary CompletionJul 26, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.0 years ago
Interventions
Synflorix™( GSK1024850A)biological
Intramuscular, 3 doses
Infanrix hexa™biological
Intramuscular, 3 doses