Major malaria vaccine trial could save thousands of children
NCT ID NCT04704830
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This large-scale study tests the R21/Matrix-M vaccine to prevent malaria in 4,800 children aged 5-36 months living in Africa. The vaccine aims to protect against the most dangerous form of malaria. Researchers will measure how well it works and check for side effects over one year.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 4,800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2021
- Expected to finish
-
Apr 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
5 to 36 months
- Sex
-
Anyone
- Healthy volunteers
-
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 participants must satisfy the following criteria at study entry: * The child is 5-36 months of age at the time of first vaccination. * Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial. * The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study. * The child is a permanent resident of the study area and likely to remain a resident for the duration of the trial. Exclusion Criteria: The following criteria should be checked at the time of study entry. If any apply, the participant must not be included: * The child has previously received a malaria vaccine. * The child is enrolled in another malaria intervention trial. * The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria or control vaccine. * The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations. * The child has major congenital defects. * The child has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL. * The child has had a blood transfusion within one month of enrolment. * The child has been administered immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. * The child has malnutrition requiring hospital admission. * The child has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests. * Children currently meeting the WHO criteria for HIV disease of stage 3 or 4 severity. A previous history of stage 3 or 4 disease is not an exclusion. Note: There will be no routine testing for HIV. Positive diagnoses will be recorded at screening if known. * The child has received an investigational drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * The child is currently participating in another clinical trial if likely to affect data interpretation of this trial * The child has any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. Additional exclusion criteria for second phase of the trial (addition of second and third booster doses) \- Hypersensitivity to neomycin (Hepatitis A vaccine may contain traces of this).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Malaria are added.
By submitting, you agree to our Terms of use
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
-
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can scheduled malaria drugs shield infants from severe illness?
- Can a simple preventive drug cut malaria and anemia in infants?
- Can monthly malaria pills sharpen Children's minds?
- Can a pill make your blood deadly to malaria mosquitoes?
- Can a new vaccine stop malaria in its tracks?
- Can a new malaria vaccine slash childhood cases? a massive real-world test seeks answers.