At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,013 enrolled
Drug / intervention
Meningococcal vaccine GSK 134612 +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 One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Menactra® in Healthy Subjects Aged 10-25 Years
In Brief
A Phase 2 clinical trial evaluating Meningococcal vaccine GSK 134612 and Menactra® for Infections, Meningococcal. Completed, enrolled 1,013 participants across 32 sites in 2 countries.
Detailed Summary
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartAug 2010
Primary CompletionFeb 2011
Study CompletionJul 2011
TodayJul 2026
First PostedJul 19, 2010
Enrollment StartAug 19, 2010
Primary CompletionFeb 25, 2011
Study CompletionJul 29, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.0 years ago
Interventions
Meningococcal vaccine GSK 134612biological
One intramuscular injection
Menactra®biological
One intramuscular injection