Study identification

PURI

https://redirect.ema.europa.eu/resource/45256

EU PAS number

EUPAS42948

Study ID

45256

Official title and acronym

205071 - A phase IV, longitudinal, cross-sectional, retrospective, ancillary epidemiology study of the EPI-MAL-005 study to evaluate the genetic diversity in the Plasmodium falciparum parasite circumsporozoite sequences before and after the implementation of the RTS,S/AS01E vaccine in malaria-positive subjects ranging from 6 months to less than 5 years of age (EPI-MALARIA-010 VS AME)

DARWIN EU® study

No

Study countries

Ghana
Kenya

Study description

The RTS,S/AS01E vaccine has been developed for routine immunization of infants and children living in malaria-endemic countries of Sub-Saharan Africa. The aim of this retrospective, ancillary epidemiology study is to monitor the genetic diversity in circumsporozoite sequences in the Plasmodium falciparum (P. falciparum) parasite in malaria-positive subjects aged 6 months to <5 years vaccinated or not with RTS,S/AS01E.

Study status

Ongoing
Research institution and networks

Institutions

Amsterdam UMC
First published:
01/02/2024
Institution
Educational InstitutionHospital/Clinic/Other health care facility
Kintampo Health Research Centre Kintampo, Ghana, KEMRI-Walter Reed Project Kombewa, Kenya, Broad Institute (BI), Harvard T.H. Chan School of Public Health (HSPH)

Contact details

Call Center EU Clinical Trials

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline
Study protocol
Initial protocol

gsk-205071-protocol-redact

English (817.71 KB - PDF)View document
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)