Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT00994695
Brief 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
Study:
NCT00994695
Study Brief:
Protocol Section:
NCT00994695