Safety of a trivalent meningococcal ACW135 vaccine among young children in Ethiopia

Vaccine. 2007 Sep 3:25 Suppl 1:A79-82. doi: 10.1016/j.vaccine.2007.04.046. Epub 2007 May 4.

Abstract

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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Child
  • Child, Preschool
  • Dizziness / etiology
  • Ethiopia
  • Follow-Up Studies
  • Humans
  • Meningitis, Meningococcal / immunology*
  • Meningitis, Meningococcal / prevention & control
  • Meningococcal Vaccines / administration & dosage
  • Meningococcal Vaccines / adverse effects
  • Meningococcal Vaccines / immunology*
  • Middle Aged
  • Neisseria meningitidis, Serogroup W-135 / immunology*
  • Pain / etiology
  • Sleep Initiation and Maintenance Disorders / etiology
  • Time Factors
  • Treatment Outcome

Substances

  • Meningococcal Vaccines