Status:
COMPLETED
Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine
Lead Sponsor:
Armauer Hansen Research Institute, Ethiopia
Collaborating Sponsors:
World Health Organization
Addis Ababa University
Conditions:
Meningococcal Meningitis
Eligibility:
All Genders
2-29 years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- Age between 2-29 years, both sexes, living in the selected villages of Butajira area
- A written informed consent signed by the individual (\>=18y) or caretaker/guardian (2 to 17 years of age) as 18 is the legal age of maturity in Ethiopia. Assent from children/adolescents aged 12-17 years old.
- Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment
Exclusion
- Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
- Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since 1999.
- Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic reaction to any component of the vaccine
- Presence of any fever (defined as axillary temperature of 37.5 degree centigrade or more) and/or severe illness on the day of enrolment/ vaccination.
- Pregnancy.
- lactation
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00994695
Start Date
November 1 2005
End Date
November 1 2007
Last Update
October 16 2009
Active Locations (1)
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1
Butajira Hospital
Butajīra, Southern Nationality, Ethiopia