115056 - 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 identification

• EU PAS number:
  EUPAS28541
• Study ID:
  50529
• Official title and acronym:
  115056 - 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)
• DARWIN EU® study:
  No
• Study countries:
  Ghana

  Kenya

  Malawi
• Study description:
  The RTS, S/AS01E vaccine has been developed for routine immunization of children living in malaria-endemic countries of sub-Saharan Africa. This study is a post-implementation safety study (after vaccine implementation), with the primary objective to evaluate the safety of vaccine after its administration. In addition to the primary objective, the study will also evaluate the impact and effectiveness of the vaccine. Active surveillance refers to prospective cohort monitoring of the AESI and other diseases during study follow-up visits at the community level as well outpatient and inpatient visits. Enhanced hospitalisation surveillance (EHS) is defined as case detection during hospitalisation through monitoring of medical records and registries for the study participants not enrolled in active surveillance. The study targets enrolling at least 45,000 children in active surveillance (AS), including 22,500 in the exposed clusters and 22,500 in the unexposed clusters for evaluation of the vaccine safety, effectiveness and impact. In the exposed clusters are included a minimum of 20,250 children vaccinated with RTS,S/AS01E for evaluation of the vaccine safety, and a minimum of 2,250 unvaccinated children for evaluation of effectiveness and impact assuming that 80% of the 22,500 study participants will receive three doses of RTS,S/AS01E,10% will receive one or two doses and 10% will not have any dose. Malaria Vaccine Implementation Programme is considering implementing the malaria vaccine in unexposed clusters as from 2023. This decision will directly impact the temporal (before/after) and concurrent (exposed vs. unexposed clusters) comparisons. Based on this, the EHS recruitment will be stopped as from 1 Jan 2023 in sites that were not involved in the NCT02374450 study and study conclusion will be conducted in a timely manner for already enrolled subjects in those sites (EHS will stop in all sites in Malawi, Siaya and Nyando sites in Kenya and unexposed sites in Ghana).
• Study status:
  Ongoing

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Kintampo Health Research Centre Ghana, Navrongo Health Research Centre Ghana, Malawi College of Medicine Malawi, Malawi Liverpool Welcome Trust Malawi, KEMRI (WRP) Kenya, KEMRI (Ahero Clinical Trials Unit) Kenya, KEMRI (CGHR) Kenya

Study timelines

Date when funding contract was signed

Actual: 18/10/2017

Study start date

Actual: 21/03/2019

Date of final study report

Planned: 24/04/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)