NCT00356369

Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine

Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine (Intramuscularly) vs Mencevax ACWY (Subcutaneously) to Healthy Subjects (11-55 Years of Age)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives \& outcome measures of both the primary \& extension phases.

Detailed description

All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	meningococcal ACWY (vaccine)	One intramuscular dose.
BIOLOGICAL	Mencevax™ ACWY	One subcutaneous dose.

Timeline

• Start date: 2006-12-23
• Primary completion: 2007-09-07
• Completion: 2008-02-28
• First posted: 2006-07-26
• Last updated: 2018-07-03
• Results posted: 2018-06-04

Locations

3 sites across 2 countries: Philippines, Saudi Arabia