Malaria,FalciparumNCT07009847
An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
An observational study of Malaria,Falciparum and Morality, run by Serum Institute of India Pvt. Ltd. at 5 sites in 4 countries.
Trial summary
This is an observational case-control study to assess the effectiveness of the R21/Matrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Read more about this study
- Who is it for?
- Ages 5 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum, Morality
- Type of treatment
- Vaccines
- How many people
- 2,308 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 16 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will comprise children aged 5 months and above who live in R21-Malaria vaccine implementation areas in Uganda, Burkina Faso, Nigeria, Cote d'ivoire and who were eligible to have received R21-malaria vaccine based on their date of birth and age
Who may be able to join
- For Cases- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. 2 Parent/legal guardian/ caregiver of the child willing to provide the written informed consent for their child's participation in the study.
- 3 Parent/legal guardian/ caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel.
- 4 Resident of the R21/Matrix-M vaccine implementation area and brought to the study hospital /clinic or sub-site with clinical complaints. 5 Child meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
- For Controls- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. The matched control should have a date of birth within 60 days of that of the case.
- 2. Parent/legal guardian/ caregiver of the child willing to provide the informed consent for their child's participation in the study.
- 3. Parent/ legal guardian/ caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel 4. Resident of the R21/Matrix-M vaccine implementation area and who would have sought treatment at the same hospital if they had developed symptoms. Resident will be defined as child and/or child's parents/ guardian/caregiver eating and sleeping in a household in the location for most days of the week from past 6 months. The matched control should be residing in the same neighborhood as the respective case, but not from the same household.
Who cannot join
- For Cases-
- Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
- Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
- Received one or more doses of RTS,S/AS01 vaccine in the past.
- For Controls-
- Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
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- Child meeting any of the case definitions (Severe Malaria, Clinical Malaria).
- Child having history suggestive of clinical malaria in past 30 days (applicable for clinical malaria and severe malaria case-control studies only).
- Received one or more doses of RTS,S/AS01 vaccine/s in the past.
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Uganda2 sites, 2 recruiting
- Recruiting
Infectious Diseases Research Collaboration (IDRC), Uganda
Busia, Uganda
Prof. Moses Kamya, MD, +256-414-530020, mkamya@irdc-uganda.org
- Recruiting
Makerere University College of Health Sciences
Mukono
Dr Victoria Nankabirwa, +256-755-757-460, vnankabirwa@musph.ac.ug
Burkina Faso1 site, 1 recruiting
- Recruiting
Unité de Recherche Clinique de Nanoro (URCN), Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest (IRSS-DRCO), Bousse
Bousse, Burkina Faso
Prof Halidou Tinto, +226 70346354, halidoutinto@gmail.com
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
Centre de Recherche et de Lutte contre le Paludisme Institut National de Santé Publique, boulevard Nangui Abrogoua près État Major des Armées
Toumodi
Prof William Yavo, +225 05 05 17 53 53, yavowilliam@yahoo.fr
Nigeria1 site, 1 recruiting
- Recruiting
University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria
Yenagoa, Bayesla
Prof Olugbenga Mokuolu, +234-803-713-7407, mokuolu@unilorin.edu.ng
About this study
Official title: A Case Control Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
This is an observational case-control study to assess the effectiveness of the R21/Matrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Clinical malaria, severe malaria and death (all-cause) cases will be enrolled in study. For each case (severe or death) 4 controls matched for age and neighborhood will be enrolled whereas for clinical malaria case, 1 matched control will be enrolled.
- Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.
- Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum.
- Proportion of vaccinated and unvaccinated children in cases of death (all cause)
- Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.
Read the detailed description
The study will be conducted at multiple centers with the appropriate research infrastructure to carry out safety and/or effectiveness research across different countries where the R21/Matrix-M vaccine is (or will be) approved and deployed for vaccination with subsequent population uptake.
The cases will be enrolled from hospitals/clinics and the matched controls will be recruited from the community by visiting the neighborhood.
Children eligible for receiving R21/Matrix-M vaccine, residing in the geographical area where the vaccine has been deployed will be considered as either cases or controls if they meet the eligibility criteria. All participants will be screened for eligibility after obtaining informed written consent from parents/legal guardians/ caregivers.
Surveillance and detection of cases: Cases qualifying the case definitions of clinical or severe malaria, cases will be recruited from the hospitals, clinics or the sub-sites.
For deaths, cases will be recruited from the hospital or the community. Cause of death will be ascertained from hospital or available medical records as well as discussions with family or healthcare professionals who may have been involved.
Identification of controls: Four controls for each case will be recruited by study physician or field staff from community for severe malaria and death cases. For clinical malaria cases in high-transmission perennial areas, case: control ratio will be 1:1. Controls will be matched for age and neighborhood. Controls should be residing in the same neighborhood as the respective case, but not from the same house. Living controls will be enrolled against the death cases. Vaccination status will be confirmed from the vaccination/immunization cards, hospital/clinic records, home based registers, or national immunization database. History from the parents/ guardians/ caregivers will be considered in case of non-vaccination. Field staff may visit the homes of controls and (if required) cases for collection of the required data.
- Conditions
- Malaria,Falciparum, Morality
- Being tested
- Case control study of clinical malaria, Case control study of severe malaria, Case control study of death (all cause)
- Keywords
- clinical malaria, severe malaria, death (all cause)
- Medical subject headings
- Malaria, Falciparum, Malaria, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case control study of clinical malariaOther
Case control study of clinical malaria
Case control study of severe malariaOther
Case control study of severe malaria
Case control study of death (all cause)Other
Case control study of death (all cause)
| Study group | Role | What they receive |
|---|---|---|
| Case control study of Clinical malaria | Clinical Malaria case definition: Presence of axillary temperature ≥ 37.5°C and/ or history of fever within the last 48 hours before the diagnosis is made AND P. falciparum asexual parasitaemia >5000 parasites/μL detected by microscopy.
This is a case-control study to assess the effectiveness of the R21/Matrix-M Vaccine against clinical malaria in children aged ≥ 5 months of age.
Surveillance and detection of cases: Cases qualifying the case definitions of clinical, cases will be recruited from the hospitals, clinics or the sub-sites as per the respective case definitions. The required laboratory investigations will be conducted if not already done to ensure the child meets the respective case definition example: e.g. microscopy with parasite density will be conducted in the suspected cases of clinical malaria.
For clinical malaria cases in high-transmission perennial areas, the ratio of case: control will be 1:1. Controls will be matched for age and neighborhood. Receives: Other: Case control study of clinical malaria | |
| Case control study of Severe malaria | Severe Malaria case definition: Presence of P. falciparum parasitaemia detected by microscopy AND one or more of the disease severity criteria.
This is a case-control study to assess the effectiveness of the R21/Matrix-M Vaccine against severe malaria in children aged ≥ 5 months of age. Surveillance and detection of cases: Cases qualifying the case definitions of severe malaria, cases will be recruited from the hospitals, clinics or the sub-sites as per the respective case definitions. The required laboratory investigations will be conducted if not already done to ensure the child meets the respective case definition. For severe malaria cases, the ratio of case: control will be 1:4. Controls will be matched for age and neighborhood. Receives: Other: Case control study of severe malaria | |
| Case control study of death (all cause) | Death (all-cause) case definition: Children who died, of any cause excluding trauma or elective surgery, who were eligible to have received the R21/Matrix-M vaccine based on their date of birth.
This is a case-control study to assess if the R21 vaccine recipients are at an increased risk due to (all cause) mortality in children aged ≥ 5 months of age. Surveillance and detection of cases: For deaths, cases will be recruited from the hospital or the community (house visits). Cause of death can be ascertained from hospital or available medical records as well as discussions with family or healthcare professionals who may have been involved. For death (all cause) cases, the ratio of case: control will be 1:4. living controls will be enrolled and matched for age and neighborhood. Receives: Other: Case control study of death (all cause) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Effectiveness against Severe Malaria caused by P. falciparum
Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.
Measured: through study, an average of one year
Vaccine Effectiveness against clinical malaria caused by P. falciparum in high perennial transmission areas
Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases caused by P. falciparum.
Measured: through study, an average of one year
Risk of death (all cause) due to R21-vaccination
Proportion of vaccinated and unvaccinated children in cases of death
Measured: through study, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start16 Jun 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009847
- Sponsor's protocol ID
- R21-PMS-01
- Status last verified
- Aug 2025
- First submitted
- 7 Apr 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Control Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
- ClinicalTrials.gov ID
- NCT07009847
- Acronym / sponsor ID
- R21-PMS-01
- Conditions
- Malaria,Falciparum, Morality
- Keywords
- clinical malaria, severe malaria, death (all cause)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,308 participants (estimated)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational case-control study to assess the effectiveness of the R21/Matrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Clinical malaria, severe malaria and death (all-cause) cases will be enrolled in study. For each case (severe or death) 4 controls matched for age and neighborhood will be enrolled whereas for clinical malaria case, 1 matched control will be enrolled.
- Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.
- Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum.
- Proportion of vaccinated and unvaccinated children in cases of death (all cause)
- Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.
Detailed description
The study will be conducted at multiple centers with the appropriate research infrastructure to carry out safety and/or effectiveness research across different countries where the R21/Matrix-M vaccine is (or will be) approved and deployed for vaccination with subsequent population uptake.
The cases will be enrolled from hospitals/clinics and the matched controls will be recruited from the community by visiting the neighborhood.
Children eligible for receiving R21/Matrix-M vaccine, residing in the geographical area where the vaccine has been deployed will be considered as either cases or controls if they meet the eligibility criteria. All participants will be screened for eligibility after obtaining informed written consent from parents/legal guardians/ caregivers.
Surveillance and detection of cases: Cases qualifying the case definitions of clinical or severe malaria, cases will be recruited from the hospitals, clinics or the sub-sites.
For deaths, cases will be recruited from the hospital or the community. Cause of death will be ascertained from hospital or available medical records as well as discussions with family or healthcare professionals who may have been involved.
Identification of controls: Four controls for each case will be recruited by study physician or field staff from community for severe malaria and death cases. For clinical malaria cases in high-transmission perennial areas, case: control ratio will be 1:1. Controls will be matched for age and neighborhood. Controls should be residing in the same neighborhood as the respective case, but not from the same house. Living controls will be enrolled against the death cases. Vaccination status will be confirmed from the vaccination/immunization cards, hospital/clinic records, home based registers, or national immunization database. History from the parents/ guardians/ caregivers will be considered in case of non-vaccination. Field staff may visit the homes of controls and (if required) cases for collection of the required data.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case control study of Clinical malaria | – | Other: Case control study of clinical malariaClinical Malaria case definition: Presence of axillary temperature ≥ 37.5°C and/ or history of fever within the last 48 hours before the diagnosis is made AND P. falciparum asexual parasitaemia >5000 parasites/μL detected by microscopy. This is a case-control study to assess the effectiveness of the R21/Matrix-M Vaccine against clinical malaria in children aged ≥ 5 months of age. Surveillance and detection of cases: Cases qualifying the case definitions of clinical, cases will be recruited from the hospitals, clinics or the sub-sites as per the respective case definitions. The required laboratory investigations will be conducted if not already done to ensure the child meets the respective case definition example: e.g. microscopy with parasite density will be conducted in the suspected cases of clinical malaria. For clinical malaria cases in high-transmission perennial areas, the ratio of case: control will be 1:1. Controls will be matched for age and neighborhood. |
| Case control study of Severe malaria | – | Other: Case control study of severe malariaSevere Malaria case definition: Presence of P. falciparum parasitaemia detected by microscopy AND one or more of the disease severity criteria. This is a case-control study to assess the effectiveness of the R21/Matrix-M Vaccine against severe malaria in children aged ≥ 5 months of age. Surveillance and detection of cases: Cases qualifying the case definitions of severe malaria, cases will be recruited from the hospitals, clinics or the sub-sites as per the respective case definitions. The required laboratory investigations will be conducted if not already done to ensure the child meets the respective case definition. For severe malaria cases, the ratio of case: control will be 1:4. Controls will be matched for age and neighborhood. |
| Case control study of death (all cause) | – | Other: Case control study of death (all cause)Death (all-cause) case definition: Children who died, of any cause excluding trauma or elective surgery, who were eligible to have received the R21/Matrix-M vaccine based on their date of birth. This is a case-control study to assess if the R21 vaccine recipients are at an increased risk due to (all cause) mortality in children aged ≥ 5 months of age. Surveillance and detection of cases: For deaths, cases will be recruited from the hospital or the community (house visits). Cause of death can be ascertained from hospital or available medical records as well as discussions with family or healthcare professionals who may have been involved. For death (all cause) cases, the ratio of case: control will be 1:4. living controls will be enrolled and matched for age and neighborhood. |
Who may qualify
- Ages
- 5 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise children aged 5 months and above who live in R21-Malaria vaccine implementation areas in Uganda, Burkina Faso, Nigeria, Cote d'ivoire and who were eligible to have received R21-malaria vaccine based on their date of birth and age
Key inclusion criteria (6 listed)
- For Cases- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. 2 Parent/legal guardian/ caregiver of the child willing to provide the written informed consent for their child's participation in the study.
- 3 Parent/legal guardian/ caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel.
- 4 Resident of the R21/Matrix-M vaccine implementation area and brought to the study hospital /clinic or sub-site with clinical complaints. 5 Child meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
- For Controls- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. The matched control should have a date of birth within 60 days of that of the case.
- 2. Parent/legal guardian/ caregiver of the child willing to provide the informed consent for their child's participation in the study.
Key exclusion criteria (9 listed)
- For Cases-
- Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
- Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
- Received one or more doses of RTS,S/AS01 vaccine in the past.
- For Controls-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case control study of clinical malariaCase control study of clinical malaria | Other | Case control study of Clinical malaria |
| Case control study of severe malariaCase control study of severe malaria | Other | Case control study of Severe malaria |
| Case control study of death (all cause)Case control study of death (all cause) | Other | Case control study of death (all cause) |
Primary outcome
Vaccine Effectiveness against Severe Malaria caused by P. falciparum
Time frame: through study, an average of one year
Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.
Vaccine Effectiveness against clinical malaria caused by P. falciparum in high perennial transmission areas
Time frame: through study, an average of one year
Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases caused by P. falciparum.
Risk of death (all cause) due to R21-vaccination
Time frame: through study, an average of one year
Proportion of vaccinated and unvaccinated children in cases of death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria,Falciparum and Morality, run by Serum Institute of India Pvt. Ltd. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Uganda, Burkina Faso, Côte d’Ivoire, Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Prasad Kulkarni, MD, FRCP (+91-20-7194-6820, drpsk@seruminstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Effectiveness against Severe Malaria caused by P. falciparum (time frame: through study, an average of one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.