At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 224 enrolled
Drug / intervention
Infanrix™ hexabiological
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.
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants
In Brief
A Phase 4 clinical trial evaluating Infanrix™ hexa for Hepatitis B and 5 related conditions. Completed, enrolled 224 participants across 3 sites.
Detailed Summary
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Tetanus, Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Acellular Pertussis
CountriesCanada
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartSep 2008
Primary CompletionMar 2013
TodayJul 2026
First PostedSep 16, 2008
Enrollment StartSep 23, 2008
Primary CompletionMar 12, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.8 years ago
Interventions
Infanrix™ hexabiological
Intramuscular, three doses