At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 86 enrolled
Drug / intervention
Meningococcal vaccine GSK134612biological
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' Meningococcal Vaccine GSK 134612 Administered to at Risk Subjects From 1 to Less Than 18 Years
In Brief
A Phase 3 clinical trial evaluating Meningococcal vaccine GSK134612 for Infections, Meningococcal. Completed, enrolled 86 participants across 16 sites in 2 countries.
Detailed Summary
The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesCzechia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartSep 2012
Primary CompletionOct 2014
Study CompletionMar 2015
TodayJul 2026
First PostedJul 16, 2012
Enrollment StartSep 10, 2012
Primary CompletionOct 10, 2014
Study CompletionMar 3, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.0 years ago
Interventions
Meningococcal vaccine GSK134612biological
2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.