Clinical Trials Directory

Trials / Completed

CompletedNCT01154088

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,170 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
18 Years – 25 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BIOLOGICALMencevax ACWYOne dose, Subcutaneous injection
BIOLOGICALGSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]One dose, Intramuscular injection

Timeline

Start date
2010-08-27
Primary completion
2010-12-30
Completion
2010-12-30
First posted
2010-06-30
Last updated
2018-11-26
Results posted
2018-11-26

Locations

3 sites across 3 countries: Panama, Philippines, Thailand

Source: ClinicalTrials.gov record NCT01154088. Inclusion in this directory is not an endorsement.