NCT00196963

Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs

Assess the Immunogenicity, Safety, Reactogenicity of 1 Dose of 4 Different Formulations of GSK Biologicals' Meningococcal Conjugate Vaccine (MenACWY) vs 1 Dose of Mencevax™ ACWY in Healthy Subjects Aged 15-19 Yrs

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Years – 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.

Detailed description

3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or of the active control (Mencevax™ ACWY) will be done in an open manner. Subjects will receive one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine), and will have 2 blood samples taken, before and one month after vaccination.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (vaccine)

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2005-09-20
• Last updated: 2016-09-21

Locations

1 site across 1 country: Belgium