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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/47949
• EU PAS number:
  EUPAS43920
• Study ID:
  47949
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Burkina Faso

  Ghana

  Kenya

  Malawi

  Senegal

  Tanzania, United Republic of
• Study description:
  This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003 studies, enrolling from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. ; The co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.
• Study status:
  Ongoing

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Biologicals

Centre de Recherche en Santé de Nouna (CRSN) Nouna, Burkina Faso, Centre National de Recherche et de Formation sur le Paludisme (CNRFP) Ouagadougou, Burkina Faso, Kintampo Health Research Centre (KHRC) Kintampo, Ghana, Navrongo Health Research Centre (NHRC) Navrongo, Ghana, KEMRI-Walter Reed Project (KEMRI-WRAIR) Kombewa, Kenya, KEMRI / CDC Research and Public Health Collaboration Kisumu, Kenya, KEMRI (Ahero Clinical Trials Unit) Kisumu, Kenya, Malawi College of Medicine (COM) Mangochi, Malawi, Malawi Liverpool Welcome Trust (MLW) Blantyre, Malawi, Département de Parasitologie, Centre de Recherche de Keur Socé, Faculté de Médecine, Université Cheikh Anta Diop Dakar, Senegal

Study timelines

Date when funding contract was signed

Planned: 21/01/2014

Actual: 21/01/2014

Study start date

Planned: 31/10/2014

Actual: 22/10/2014

Date of final study report

Planned: 04/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-116682-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)