Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine

Launched by ARMAUER HANSEN RESEARCH INSTITUTE, ETHIOPIA · Oct 13, 2009

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 2-29 years, both sexes, living in the selected villages of Butajira area
• • 2. 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.
• • 3. Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment
• Exclusion Criteria:
• • 1. Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
• • 2. 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.
• • 3. Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
• • 4. Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since 1999.
• • 5. Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
• • 6. A family history of congenital or hereditary immunodeficiency.
• • 7. History of allergic reaction to any component of the vaccine
• • 8. 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.
• • 9. Pregnancy.
• • 10. lactation