CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 692 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/NCT01767376
NCT01767376Phase 3Completed
CompareCT.gov

Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Healthy Adolescents and Young Adults Between 11 and 25 Years of Age

GlaxoSmithKline·interventional·Posted Jan 14, 2013·Updated Sep 6, 2017

In Brief

A Phase 3 clinical trial evaluating Meningococcal vaccine GSK134612 and Boostrix® for Infections, Meningococcal. Completed, enrolled 692 participants across 15 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy adolescents and young adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesDominican Republic, Germany, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2013
Enrollment StartJan 10, 2013
Primary CompletionJan 16, 2014
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 13.5 years ago

Interventions

Meningococcal vaccine GSK134612biological

One dose administered intramuscularly (IM) in the deltoid muscle of the arm.

Boostrix®biological

One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).