MedTrace Logo

Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine

NCT00994695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2009-10-16

No results posted yet for this study

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

BIOLOGICAL

Mencevax ACW Vaccine

Mencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted).

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Addis Ababa University

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Armauer Hansen Research Institute, Ethiopia

    lead OTHER

Principal Investigators

  • Abraham Aseffa Aseffa, M.D, PhD · Senior Sientist,Deputy Director, AHRI

  • Ahmed Bedru Omer, M.D,Pediatrician · Clinical Trial coordinator,AHRI

Study Design

Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-01-31
Completion
2007-11-30

Countries

  • Ethiopia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00994695 on ClinicalTrials.gov