At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 873 enrolled
Drug / intervention
Meningococcal vaccine 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.
Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.
In Brief
A Phase 2 clinical trial evaluating Meningococcal vaccine 134612 and Menactra® for Infections, Meningococcal. Completed, enrolled 873 participants across 10 sites.
Detailed Summary
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2007
Enrollment StartApr 2007
Primary CompletionOct 2007
Study CompletionApr 2008
TodayJul 2026
First PostedApr 2, 2007
Enrollment StartApr 23, 2007
Primary CompletionOct 31, 2007
Study CompletionApr 11, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.3 years ago
Interventions
Meningococcal vaccine 134612biological
Single dose intramuscular injection.
Menactra®biological
Single dose intramuscular injection.