Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine (ETH-TVT)
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|ClinicalTrials.gov Identifier: NCT00994695|
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : October 16, 2009
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.
- 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.
- 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.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Meningococcal Meningitis||Biological: Mencevax ACW Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||412 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||November 2007|
Biological: Mencevax ACW Vaccine
- To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive) [ Time Frame: 28 days ]
- To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination. [ Time Frame: 28days ]
- To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination. [ Time Frame: 23 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994695
|Butajira, Southern Nationality, Ethiopia|
|Principal Investigator:||Abraham Aseffa Aseffa, M.D, PhD||Senior Sientist,Deputy Director, AHRI|
|Principal Investigator:||Ahmed Bedru Omer, M.D,Pediatrician||Clinical Trial coordinator,AHRI|