Major malaria vaccine trial could save thousands of children

NCT ID NCT04704830

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Our safety recommendation!

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.