At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 415 enrolled
Drug / intervention
Boostrix-Poliobiological
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.
Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.
In Brief
A Phase 4 clinical trial evaluating Boostrix-Polio for Poliomyelitis and 3 related conditions. Completed, enrolled 415 participants across 38 sites.
Detailed Summary
Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis, Diphtheria, Tetanus, Acellular Pertussis
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedMar 2008
Primary CompletionJul 2008
TodayJul 2026
First PostedMar 13, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 8, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.3 years ago
Interventions
Boostrix-Poliobiological
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.