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Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

NCT01154088 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1170

Last updated 2018-11-26

Study results available
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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.

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

Mencevax ACWY

One dose, Subcutaneous injection

BIOLOGICAL

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

One dose, Intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-27
Primary Completion
2010-12-30
Completion
2010-12-30

Countries

  • Panama
  • Philippines
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01154088 on ClinicalTrials.gov