Massive malaria vaccine trial shows promise for protecting children
NCT ID NCT03855995
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the RTS,S/AS01E malaria vaccine in nearly 78,000 young children in Sub-Saharan Africa. Researchers checked the vaccine's safety and how well it prevents malaria. The goal was to see if the vaccine can be safely used in routine immunization programs to protect children from this deadly disease.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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77,953 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The target population for the introduction of the RTS,S/AS01E vaccine are children living in the SSA.
- Ages
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Up to 5 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria All study participants must satisfy ALL the following criteria at study entry: * Study participants' parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent provided from either the parent(s) or LAR of the study participant. * Study participant living in the HDSS or equivalent surveillance system area. * For enrolment in the active surveillance - DTP group: children must be aged less than (\<) 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, (=who either received all DTP/HepB/Hib doses before study start or received at least one dose of DTP/HepB/Hib and are older than the age corresponding to the 3rd DTP/HepB/Hib dose at study start) and identified at 1st RTS,S/AS01E dose administration (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.) Parents/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 hospitalization monitored as part of the procedures related to the active surveillance and can therefore not be enrolled in enhanced hospitalization surveillance. Exclusion Criteria: • Child in care = A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government, or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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GSK Investigational Site
Kintampo, Ghana
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GSK Investigational Site
Navrongo, Ghana
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GSK Investigational Site
Kisumu, 4 0100, Kenya
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GSK Investigational Site
Kisumu, 40100, Kenya
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GSK Investigational Site
Chikwawa, Malawi
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GSK Investigational Site
Mangochi, Malawi
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Other studies related to the condition(s) this trial covers.
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