NCT00994695

Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine

A Phase II Open and Parallel Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Polysaccharide Vaccine Comparing Three Groups: 2 - 4 Year, 5 - 14 Year and 15 - 29 Year Old Ethiopians

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Armauer Hansen Research Institute, Ethiopia · Academic / Other
• Sex: All
• Age: 2 Years – 29 Years
• Healthy volunteers: Accepted

Summary

Primary objective: To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups. Secondary Objectives: * To estimate the incidence of common adverse events following immunization (AEFI) of GSK Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination * To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23 months post vaccination in 2-4, 5-14, 15-29 year age groups Study site:Two rural communities (Kebele) in Butajira district, Ethiopia. Methods: * Phase II, open and parallel safety and immunogenicity trial. * 234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29 years of age) were randomly selected from the demographic surveillance database and enrolled after screening and consenting. * Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml subcutaneously. * Blood samples for measuring SBA titres were collected at pre vaccination and on day 28 (+6 days) post vaccination. * Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, \& 28. * Primary end point was vaccine response defined as sero-conversion (in subjects initially seronegative) or a 4 fold increase (in subjects initially seropositive) in serum bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28 post vaccination. * Secondary endpoints were incidence of general and local symptoms and other adverse events following immunisation during the post vaccination period day 0 to 28 and immune persistence on post vaccination month-11 and month-23. Results: * No significant difference in the incidence of general or local AEFI was observed between the age groups * The statistical analysis for the Immunogenicity data is in progress

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Mencevax ACW Vaccine	Mencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted).

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-01-01
• Completion: 2007-11-01
• First posted: 2009-10-14
• Last updated: 2009-10-16

Locations

1 site across 1 country: Ethiopia