NCT00227422

Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 Yrs

A Phase IV, Partially Double-blind Study to Demonstrate Non-inferiority of GSK Biologicals' Mencevax™ ACWY (New Process) Versus Mencevax™ ACWY (Current Process) When Administered as a Single Dose to Subjects Aged 2-30 Yrs

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 324 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.

Detailed description

"Randomized study with four groups to receive one of the following vaccination regimens: - One of the 3 lots of GSK Biologicals' Mencevax™ ACWY vaccine manufactured by the new process (3 different groups) - GSK Biologicals' already existing Mencevax™ ACWY

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Mencevax ACWY

Timeline

• Start date: 2005-06-01
• Completion: 2005-11-01
• First posted: 2005-09-28
• Last updated: 2016-09-21

Locations

1 site across 1 country: Lebanon