At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,133 enrolled
Drug / intervention
DTaP-HB-PRP~T combined vaccine +2 morebiological
Likely dose
DTaP-HB-PRP~T combined vaccine 0.5 mLfrom 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.
Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants
In Brief
A Phase 3 clinical trial evaluating DTaP-HB-PRP~T combined vaccine, Tritanrix-HepB/Hib™ vaccine, and 1 other intervention for Diphtheria and 4 related conditions. Completed, enrolled 2,133 participants across 4 sites.
Detailed Summary
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
CountriesPhilippines
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedJul 2006
Primary CompletionOct 2007
Study CompletionJun 2008
TodayJul 2026
First PostedJul 6, 2006
Enrollment StartJun 1, 2006
Primary CompletionOct 1, 2007
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.0 years ago
Interventions
DTaP-HB-PRP~T combined vaccinebiological
0.5 mL, Intramuscular
Tritanrix-HepB/Hib™ vaccinebiological
0.5 mL, Intramuscular
Oral poliomyelitis vaccine (OPV)biological
Oral co-administered with study vaccine.