Safety of a trivalent meningococcal ACW135 vaccine among young children in Ethiopia.
A phase II open and parallel reactogenicity, immunogenicity and safety trivalent meningitis vaccine (Mencevax) trial was conducted on 413 volunteer 2-29-year-old rural residents in Ethiopia in November/December 2005. Adverse events (AE) were monitored at 1h, 1, 2, 3, 7 and 28 days after vaccination. No serious AE occurred except for burn injury (one) and severe malaria (one) after day 28. Irritability (45/411), loss of appetite (27/411), pain at injection site (26/412), dizziness (18/409), crying (14/411), insomnia, headache and diarrhoea (13/411) were the most frequent AEs. Overall, the vaccine is safe in the age groups studied.
Aseffa
Abraham
A
Armauer Hansen Research Institute, ALERT Compound, Addis Ababa, Ethiopia. aseffaa2@yahoo.com
Bedru
Ahmed
A
Yamuah
Lawrence
L
Arga
Demis
D
Worku
Alemayehu
A
Chandramohan
Daniel
D
Nelson
Christopher B
CB
Engers
Howard D
HD
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004244:Dizziness / Q000209:etiology; D005002:Ethiopia; D005500:Follow-Up Studies; D006801:Humans; D008585:Meningitis, Meningococcal / Q000276:immunology* / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D008875:Middle Aged; D038582:Neisseria meningitidis, Serogroup W-135 / Q000276:immunology*; D010146:Pain / Q000209:etiology; D007319:Sleep Initiation and Maintenance Disorders / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D022401:Meningococcal Vaccines