At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 458 enrolled
Drug / intervention
DTPa-IPV +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.
A Multicentric Study to Compare the Immunogenicity, Safety & Reactogenicity of GSK Biologicals' DTPa-IPV Vaccine vs. Co-administration of GSK's DTPa Vaccine & Sanofi-Pasteurs' IPV Vaccine at Different Injection Sites, to Healthy Children
In Brief
A Phase 3 clinical trial evaluating DTPa-IPV, DTPa, and 1 other intervention for Tetanus and 2 related conditions. Completed, enrolled 458 participants across 9 sites.
Detailed Summary
DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Acellular Pertussis, Diphtheria
CountriesSouth Korea
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedFeb 2006
Primary CompletionJan 2007
Study CompletionJan 2007
TodayJul 2026
First PostedFeb 13, 2006
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2007
Study CompletionJan 23, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.4 years ago
Interventions
DTPa-IPVbiological
3 intramuscular injections
DTPabiological
3 intramuscular injections
IMOVAX Polio®biological
3 intramuscular injections