For Healthcare Professionals

A Study to Evaluate the Safety, Effectiveness and Impact of the GlaxoSmithKline Biologicals' Malaria Vaccine- RTS, S/AS01E in Young Children in Sub-Saharan Africa


About the study

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 intended as 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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Study participants' parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  2. Written informed consent provided from either the parent(s) or LAR of the study participant.
  3. Study participant living in the HDSS or equivalent surveillance system area.
  4. For enrolment in the active surveillance - DTP group: children must be aged <18 months, identified at any administration of DTP/HepB/Hib (or at hospitalisation before 3rd dose of DTP/HepB/Hib in case of hospitalisation and vaccinated with at least one dose of DTP/HepB/Hib). (This group will include children from exposed and unexposed clusters.) OR For enrolment in the active surveillance - Catch-up group: children must be aged < 18 months, received at least one dose of DTP/HepB/Hib vaccine, whose age corresponds to the age after the 3rd dose of DTP/HepB/Hib vaccine and identified at administration of first dose of RTS,S/AS01E vaccine (This group will include children from exposed clusters only).

OR For enrolment in the enhanced hospitalisation surveillance: children must be aged at least 6 weeks and < 5 years at the time of hospitalisation at any time during the study. (This group will include children from exposed and unexposed clusters.) Parent(s)/LARs of children meeting all eligibility criteria for active surveillance, not having completed the visits for DTP/HepB/Hib, and first identified during hospitalisation, must first be proposed enrolment in active surveillance (if recruitment is not completed).

Children already enrolled in active surveillance will have hospitalisation monitored as part of the procedures related to the active surveillance and can therefore not be enrolled in enhanced hospitalisation surveillance.


Exclusion Criteria:

• Child in care

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.
Phone iconCall 877-379-3718Email iconEmail Study Center

Study’s details


Malaria,Malaria Vaccines

Age (in years)

< 5

Participants needed


Est. Completion Date

Feb 26, 2025

Treatment type



GlaxoSmithKline identifier


Study number


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