At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 660 enrolled
Drug / intervention
Infanrix™/Hib +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.
Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.
In Brief
A Phase 3 clinical trial evaluating Infanrix™/Hib, Infanrix, and 1 other intervention for Tetanus and 2 related conditions. Completed, enrolled 660 participants across 2 sites.
Detailed Summary
This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 \& 5 months of age, in terms of safety and immunogenicity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Diphtheria, Acellular Pertussis
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2006
Enrollment StartJan 2007
Primary CompletionJun 2007
Study CompletionJun 2007
TodayJul 2026
First PostedDec 19, 2006
Enrollment StartJan 3, 2007
Primary CompletionJun 1, 2007
Study CompletionJun 25, 2007
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 19.5 years ago
Interventions
Infanrix™/Hibbiological
Infanrixbiological
Hiberixbiological