At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 721 enrolled
Drug / intervention
Infanrix hexa™ +2 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.
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) in Primary Infant Vaccination
In Brief
A Phase 2 clinical trial evaluating Infanrix hexa™, Prevenar 13®, and 1 other intervention for Tetanus and 5 related conditions. Completed, enrolled 721 participants across 16 sites in 2 countries.
Detailed Summary
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria
CountriesDominican Republic, Finland
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartDec 2010
Primary CompletionJan 2012
TodayJul 2026
First PostedNov 25, 2010
Enrollment StartDec 9, 2010
Primary CompletionJan 5, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.6 years ago
Interventions
Infanrix hexa™biological
3 doses, intramuscular into left thigh
Prevenar 13®biological
3 co-administered doses, intramuscular into right thigh
GSK217744biological
3 doses, intramuscular into left thigh