CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,170 enrolled
Drug / intervention
Mencevax ACWY +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/NCT01154088
NCT01154088Phase 3Completed
CompareCT.gov

Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Mencevax™ ACWY in Healthy Subjects Aged 18-25 Years

GlaxoSmithKline·interventional·Posted Jun 30, 2010·Updated Nov 26, 2018

In Brief

A Phase 3 clinical trial evaluating Mencevax ACWY and GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] for Infections, Meningococcal. Completed, enrolled 1,170 participants across 3 sites in 3 countries.

Detailed Summary

The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK's 134612 vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesPanama, Philippines, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2010
Enrollment StartAug 27, 2010
Primary CompletionDec 30, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.0 years ago

Interventions

Mencevax ACWYbiological

One dose, Subcutaneous injection

GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]biological

One dose, Intramuscular injection