At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 387 enrolled
Drug / intervention
Boostrix PolioTM +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.
Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children
In Brief
A Phase 3 clinical trial evaluating Boostrix PolioTM, RepevaxTM, and 1 other intervention for Acellular Pertussis and 3 related conditions. Completed, enrolled 387 participants across 13 sites.
Detailed Summary
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Poliomyelitis, Tetanus, Diphtheria
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartApr 2011
Primary CompletionMar 2012
Study CompletionApr 2012
TodayJul 2026
First PostedNov 22, 2010
Enrollment StartApr 1, 2011
Primary CompletionMar 27, 2012
Study CompletionApr 2, 2012
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 15.6 years ago
Interventions
Boostrix PolioTMbiological
Single dose, intramuscular administration.
RepevaxTMbiological
Single dose, intramuscular administration.
PriorixTMbiological
Single dose, intramuscular or subcutaneous administration.