At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
Infanrix hexa™biological
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 India
In Brief
A Phase 3 clinical trial evaluating Infanrix hexa™ for Poliomyelitis and 6 related conditions. Completed, enrolled 224 participants across 4 sites.
Detailed Summary
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Hepatitis B, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartApr 2012
Primary CompletionFeb 2013
TodayJul 2026
First PostedMay 16, 2011
Enrollment StartApr 16, 2012
Primary CompletionFeb 25, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.1 years ago
Interventions
Infanrix hexa™biological
Intramuscular, three doses