Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

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
    


Intervention name(s): Mencevax ACW Vaccine
Intervention type(s): Biological
Intervention description(s): Mencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted).
Other intervention name(s): Mencevax ACW polysaccharide vaccine
Intervention MeSH terms: Vaccines
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Trivalent meningococcal polysaccharide vaccine; Children; Safety; Immunogenicity; To assess Safety of trivalent meningococcal polysaccharide vaccine in children; To assess the immunogenicity of the trivalent polysaccharide vaccine in children