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Can a new malaria vaccine slash childhood cases? a massive real-world test seeks answers.

NCT ID NCT07749911

Prevention Sponsor: Clinton Health Access Initiative Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study is checking how effective the R21/Matrix-M malaria vaccine is at protecting children under 5 in Burkina Faso and Uganda, where malaria is common. Researchers will compare vaccination history in children who test positive for malaria against those who test negative. The goal is to see if the vaccine reduces the chance of getting malaria in everyday conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
R21/Matrix-M malaria vaccine
What this could lead to
If effective, this could confirm that the R21/Matrix-M vaccine significantly reduces malaria cases in young children, supporting its wider use across Africa.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. Vaccine effectiveness could be lower in real-world conditions than in clinical trials.

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.

Participants

About 20,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2027

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.

Who is studied

Children younger than 5 years who reside in the catchment areas of selected health facilities in R21/Matrix-M implementation districts in Burkina Faso or Uganda, are age-eligible for vaccination under the relevant national schedule, and present for outpatient care with suspected malaria. Participants are recruited from health facilities in moderate- to high-transmission settings.

Ages

5 months to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Residence in an area where R21/Matrix-M is implemented and within the catchment area of a selected study facility. * Younger than 5 years and eligibleto receive R21/Matrix-M under the national vaccination schedule at rollout. * Meets the country definition of suspected malaria, generally axillary temperature of at least 37.5 degrees Celsius or a history of fever within the previous 24 hours, and is undergoing malaria testing. * Written informed consent provided by an adult caregiver aged 18 years or older. Exclusion Criteria: * Caregiver is unable or unwilling to provide informed consent. * Severe non-malaria illness at presentation that would interfere with study participation. * Repeat presentation within the protocol-defined exclusion window after a previous enrollment: within 14 days after a microscopy-positive visit; or more than 7 but fewer than 14 days after a microscopy-negative visit. A microscopy-negative visit followed by a positive diagnosis within 7 days will be reclassified as positive rather than treated as a new enrollment. * Documented receipt of any RTS,S malaria vaccine dose.

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Conditions

The condition(s) this trial relates to.

malaria Plasmodium falciparum malaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malaria Plasmodium falciparum malaria

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boromo urbain 1

    RECRUITING

    Boromo, Boucle Mouhoun, Burkina Faso

  • Béréba

    RECRUITING

    Houndé, Hauts-Bassins Region, Burkina Faso

  • Dohoun

    RECRUITING

    Houndé, Hauts-Bassins Region, Burkina Faso

  • Déguélin

    RECRUITING

    Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso

  • Karangasso-Vigué

    RECRUITING

    Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso

  • Kari

    RECRUITING

    Houndé, Hauts-Bassins Region, Burkina Faso

  • Kigandalo HCIV

    NOT_YET_RECRUITING

    Mayuge, Busoga, Uganda

  • Kitgum-Matidi HCIII

    NOT_YET_RECRUITING

    Kitgum, Acholi, Uganda

  • Lalogi HCIV

    NOT_YET_RECRUITING

    Omoro, Acholi, Uganda

  • Mankarga T

    RECRUITING

    Zorgo, Oubri, Burkina Faso

  • Mankarga V3

    RECRUITING

    Zorgo, Oubri, Burkina Faso

  • Mankarga V6

    RECRUITING

    Zorgo, Oubri, Burkina Faso

  • Nadunget HCIII

    NOT_YET_RECRUITING

    Moroto, Karamoja, Uganda

  • Namokora HCIV

    NOT_YET_RECRUITING

    Kitgum, Acholi, Uganda

  • Nawaikoke HCIII

    NOT_YET_RECRUITING

    Kaliro, Busoga, Uganda

  • Orum HCIV

    NOT_YET_RECRUITING

    Otuke, Lango, Uganda

  • Otwal HCIII

    NOT_YET_RECRUITING

    Oyam, Lango, Uganda

  • Ouahabou

    RECRUITING

    Boromo, Boucle Mouhoun, Burkina Faso

  • Rwenyawawa HCIII

    NOT_YET_RECRUITING

    Kikube, Bunyoro, Uganda

  • Sourmousso

    RECRUITING

    Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso

  • Wara

    RECRUITING

    Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso

More trials for these conditions

Other studies related to the condition(s) this trial covers.