CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,025 enrolled
Drug / intervention
Meningococcal vaccine GSK134612 +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/NCT00464815
NCT00464815Phase 3Completed

Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY

GlaxoSmithKline·interventional·Posted Apr 24, 2007·Updated Jun 8, 2018

In Brief

A Phase 3 clinical trial evaluating Meningococcal vaccine GSK134612 and Mencevax™ ACWY for Infections, Meningococcal. Completed, enrolled 1,025 participants across 7 sites in 3 countries.

Detailed Summary

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia, Philippines, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2007
Enrollment StartMay 2, 2007
Primary CompletionApr 16, 2008
Study CompletionSep 10, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.2 years ago

Interventions

Meningococcal vaccine GSK134612biological

One intramuscular dose

Mencevax™ ACWYbiological

One subcutaneous dose