A prospective study to evaluate the safety, effectiveness and impact of the RTS, S/AS01E vaccine in young children in sub-Saharan Africa (EPI-MALARIA-003 VS AME)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Cluster Design

Study drug and medical condition

• Medical condition to be studied:
  Meningitis

Population studied

• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
• Estimated number of subjects:
  45000

Study design details

• Main study objective:
  • To estimate the incidence of adverse events of special interest (AESI) in children vaccinated with RTS,S/AS01E. • To estimate the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E.
• Setting:
  Specific locations in sub-Saharan Africa with moderate to high malaria transmission.; A geographically confined region equipped with a demographic surveillance system and robust infrastructure for tracking population health and vaccination programs.
• Outcomes:
  - Incidence rates of adverse events of special interest (AESI);; - Incidence rates of aetiology-confirmed meningitis cases;; - Incidence rates of probable meningitis (final classification);; - Incidence rates of clinically suspected meningitis (final classification);; - Number of meningitis cases identified at site level (first line laboratory);; - Incidence rates of cerebral malaria cases (diagnosed by Rapid Diagnostic Test [RDT] and/or microscopy);; - Incidence rates of malaria episodes diagnosed by RDT and/or microscopy;; - Incidence rates of anaemia cases at hospital entry among hospitalised children;; - Incidence rates of hospitalisation cases;; - Number of deaths.
• Data analysis plan:
  All data analyses will be computed in a descriptive manner. Data regarding the hospitalisation will be uniformly collected whether the child is enrolled in active surveillance or in enhanced hospitalisation surveillance.