CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 611 enrolled
Drug / intervention
Nimenrix (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.

Search/NCT00465816
NCT00465816Phase 3Completed
CompareCT.gov

Non-inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals' Twinrix™ Versus 134612 Alone and Twinrix™ Alone in Healthy Subjects Aged 11 Through 17 Years.

GlaxoSmithKline·interventional·Posted Apr 25, 2007·Updated Jun 8, 2018

In Brief

A Phase 3 clinical trial evaluating Nimenrix (Meningococcal vaccine 134612) and Twinrix for Infections, Meningococcal. Completed, enrolled 611 participants across 6 sites in 2 countries.

Detailed Summary

This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesDenmark, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2007
Enrollment StartApr 11, 2007
Primary CompletionApr 28, 2008
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 19.2 years ago

Interventions

Nimenrix (Meningococcal vaccine 134612)biological

Single dose intramuscular injection

Twinrixbiological

3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.