At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 671 enrolled
Drug / intervention
Boostrix TM (new syringe presentation) +1 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 Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years
In Brief
A Phase 4 clinical trial evaluating Boostrix TM (new syringe presentation) and Boostrix TM (previous syringe presentation) for Diphtheria and 2 related conditions. Completed, enrolled 671 participants across 3 sites in 2 countries.
Detailed Summary
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Acellular Pertussis
CountriesChile, Mexico
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJul 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedMay 30, 2011
Enrollment StartJul 1, 2011
Primary CompletionSep 3, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.1 years ago
Interventions
Boostrix TM (new syringe presentation)biological
Single dose, intramuscular administration in a new syringe presentation
Boostrix TM (previous syringe presentation)biological
Single dose, intramuscular administration in previous syringe presentation