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 identification

• EU PAS number:
  EUPAS45288
• Study ID:
  50414
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Burkina Faso

  Ghana

  Kenya
• Study description:
  The purpose of this pre-licensure cohort study is to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of this study will provide the baseline data for the post-licensure EPI-MALARIA-003 (115056) study that will evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine. An interim analysis was performed on a sub-group of study participants enrolled in active surveillance from sites where the vaccine is currently implemented, having 6 months of follow-up following the administration of dose 3 of DTP/HepB/Hib vaccine (6-12 weeks group), or 6 months after Visit 3 (mimicking the RTS,S/AS01E primary vaccination schedule) for the 5-17 months group, corresponding to Visit 5. The interim analysis concerned primary safety endpoints and the main secondary endpoints.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

IQVIA

United Kingdom

Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou Burkina Faso, Centre de Recherche en Santé de Nouna, Nouna Burkina Faso, Kintampo Health Research Centre (KHRC), Kintampo Ghana, Navrongo Health Research Centre (NHRC), Navrongo Ghana, KEMRI-Walter Reed Project (KEMRI-WRAIR), Kombewa Kenya, Network: CLS (Clinical Laboratory Services) South Africa

Networks

PATH (Program for Appropriate Technology in Health), AMP (Agence de Médecine Préventive) (in French), RAFT (Réseau en Afrique Francophone pour la Télémédecine) (in French)

Study timelines

Date when funding contract was signed

Planned: 01/06/2012

Actual: 08/05/2014

Study start date

Planned: 09/10/2015

Actual: 05/10/2015

Date of final study report

Planned: 06/06/2023

Actual: 24/05/2023

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline, Program for Appropriate Technology in Health (PATH)

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)