Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-30 @ 2:39 PM
Study NCT ID:
NCT00994695
Status:
COMPLETED
Last Update Posted:
2009-10-16
First Post:
2009-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine
Sponsor:
Armauer Hansen Research Institute, Ethiopia
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETH-TVT
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: