At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,000 enrolled
Drug / intervention
Meningococcal vaccine GSK134612 (Nimenrix) +2 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 & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children
In Brief
A Phase 3 clinical trial evaluating Meningococcal vaccine GSK134612 (Nimenrix), Priorix-Tetra, and 1 other intervention for Infections, Meningococcal. Completed, enrolled 1,000 participants across 14 sites.
Detailed Summary
The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesFinland
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJun 2007
Primary CompletionFeb 2008
Study CompletionMar 2008
TodayJul 2026
First PostedMay 16, 2007
Enrollment StartJun 5, 2007
Primary CompletionFeb 26, 2008
Study CompletionMar 26, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.1 years ago
Interventions
Meningococcal vaccine GSK134612 (Nimenrix)biological
Single dose intramuscular injection
Priorix-Tetrabiological
2-dose subcutaneous injection
Meningitecbiological
Single dose intramuscular injection