115055-A prospective study to estimate the incidence of diseases specified as adverse events of special interest, of other adverse events leading to hospitalisation or death, and of meningitis in infants and young children in sub-Saharan Africa prior to implementation of the RTS,S/AS01E candidate vaccine (EPI-MALARIA 002 VS AME)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Intensive monitoring schemes, Disease surveillance study with prospective cohort event monitoring

Study drug and medical condition

• Medical condition to be studied:
  Malaria

Population studied

• Short description of the study population:
  The study population included infants and young children < 5 years of age living in a geographically limited area with a health and demographic surveillance system (HDSS) or equivalent surveillance system in place, and an existing infrastructure to monitor population health and vaccination programmes in sub-Saharan Africa (SSA) countries.; Inclusion criteria: ; • Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.; • Written informed consent provided from either the parent(s) or LAR of the subject.; • Subject living in the HDSS or equivalent surveillance system area.; • For enrolment in the active surveillance: children must be < 18 months of age OR For enrolment in the enhanced hospitalisation surveillance: children must be ; < 5 years of age and hospitalised at any time during the study.; ; Exclusion criteria:; • Child in care.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with malaria
• Estimated number of subjects:
  30000

Study design details

• Main study objective:
  • To estimate the incidence of AESI, and of other AE leading to hospitalisation or death, in children, prior to implementation of RTS,S/AS01E. • To estimate the incidence of aetiology-confirmed meningitis, in children, prior to implementation of RTS,S/AS01E.
• Outcomes:
  Incidence of AESI, adverse events (AEs) leading to hospitalisation or death and aetiology-confirmed meningitis. Aetiology-confirmed/probable meningitis, probable meningitis, clinically suspected meningitis, Meningitis cases, risk factors for AESI and other AEs (OAEs), Hospitalisation due to AESI, OAEs, meningitis/malaria, Number of deaths by cause, Febrile convulsions, Any, severe and cerebral malaria, Anaemia for hospitalised children, All-cause malaria hospitalisations, Mortality rate
• Data analysis plan:
  • The incidence rate of each AESI and other AE leading to hospitalisation or death will be calculated by dividing the number of subjects reporting at least one event over the follow-up period by the total person-time. A 95% CI will be computed using an exact method for a Poisson variable. • The person-time for an event of interest will be calculated as the time between the reference date (date of first administration of DTP/HepB/Hib or date of first virtual vaccination, corresponding to the week before first visit) and the end of the at-risk period or the earliest of the date of: first diagnosis of event of interest, end of study period, enrolment in EPI-MAL-003 (when applicable), when child reaches 5 years, last contact (lost-to follow-up) or death. • Each AESI will be grouped after case ascertainment (for both confirmed and non-confirmed cases). • The incidence rate of aetiology-confirmed meningitis and of cerebral malaria will be computed with 95% CI as described above