116682 - An epidemiology study to assess Plasmodium falciparum parasite prevalence and malaria control measures in catchment areas of two studies pre- and post RTS,S/AS01E introduction (EPI MAL-002 and EPI-MAL-003) to assess, in field conditions, vaccine benefit:risk in children in sub Saharan Africa. (EPI-MALARIA-005 BOD AME)

Study type

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

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Malaria

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)
• Estimated number of subjects:
  54000

Study design details

• Main study objective:
  To obtain longitudinal estimates of P. falciparum parasite prevalence, assess malaria transmission intensity, and evaluate malaria control interventions at EPI-MAL-002 and EPI-MAL-003 study centers pre- and post- introduction of the RTS,S/AS01E malaria vaccine in sub-Saharan Africa.
• Outcomes:
  Number of subjects infected with P. falciparum parasitaemia (using microscopy) and number of subjects using malaria control interventions (primarily bednets), Number of subjects infected with Plasmodium species other than P. falciparum, with uptake of the third dose of DTP pentavalent and the first dose of the measles EPI vaccines, using anti-malarial therapy in the 14 days prior to the visit, with measured fever at the visit or reported fever in the 24 hours prior to the visit, demonstrating care seeking behavior, and/or presenting risk factors.
• Data analysis plan:
  • The parasite prevalence will be estimated as the proportion of subjects infected among subjects tested. The estimates of parasite prevalence will be done each year and for each site separately. ; • The estimates of the use of malaria control measures will be estimated as the number of subjects using malaria control measures divided by the number of subjects for which this information is available. The estimates of the use of malaria control measures will be done each year and for each site separately. ; • The trends in parasite prevalence between each cross-sectional malariometric surveys will be tested using the Cochran-Armitage trend test. This hypothesis test will be performed on the parasite prevalence computed on the independent samples of subjects in each survey separately within each site.