A Phase 1 interventional study of R21/Matrix-M - single vial formulation and R21/Matrix-M - two vial formulation in Malaria, sponsored by University of Oxford. Completed at 2 sites in 2 countries. Open to participants aged 6 Weeks to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by University of Oxford · Phase 1, Interventional, and Prevention
This is a Phase Ib trial conducted in Bougouni, Mali to evaluate the safety and immunogenicity of R21/Matrix-M in a single and two vial presentation, with different immunisation schedules, and when co-administered with EPI vaccines in African children.
This trial has six groups. This will be a double-blind, individually randomised trial, with 1:1 randomisation with the single or two vial presentation of R21/Matrix-M malaria vaccine for study groups 1, 2 and 3. Groups 1, 2 and 3 are to assess the safety and immunogenicity of R21/Matrix-M as a single vial formulation compared with a two-vial formulation, in children aged 5- 36 months, in a malaria endemic area. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups.
For groups 4 and 5, this is a randomised, open-label study to assess the safety and immunogenicity of R21/Matrix-M when co-administrated with various EPI vaccines at the relevant ages, in a malaria endemic area.
Group 6 is a randomised, open-label study to assess safety and immunogenicity of a delayed, third dose of R21/Matrix-M in 5-36 month old children, in a malaria endemic area.
For groups 1, 2, 3, 5 and 6, participants will be randomised 1:1. For group 4, participants will be randomised 3:3:1.
Approximately 590 children will be recruited across these six study groups.
The primary study objectives are:
Safety
Immunogenicity
The secondary study objectives are:
This trial is funded by the Serum Institute of India.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 594 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age:
Exclusion Criteria at study entry:
Exclusion criteria during the study (to be checked prior to each vaccination):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
60 children, aged 5-36 months, who will receive 4 doses of 5µg R21/50µg Matrix-M as a two vial formulation. The first three doses will be given one month apart, followed by a booster vaccination 12 months after the third dose. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups. Group 1a is 20 children aged 5-11 months, group 2a is 20 children aged 12-23 months, and group 3a is 20 children aged 24-36 months.
Biological: R21/Matrix-M - two vial formulation
60 children, aged 5-36 months, who will receive 4 doses of 5µg R21/50µg Matrix-M as a single vial formulation. The first three doses will be given one month apart, followed by a booster vaccination 12 months after the third dose. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups. Group 1b is 20 children aged 5-11 months, group 2b is 20 children aged 12-23 months, and group 3b is 20 children aged 24-36 months.
Biological: R21/Matrix-M - single vial formulation
150 participants, aged 6-7 months at the time of randomisation (to ensure third vaccination is given at approximately 9 months), who will receive 3 doses of 5µg R21/50µg Matrix-M one month apart. At the time of the third dose they will receive their measles-rubella and yellow fever vaccinations at the same time as R21/Matrix-M.
Biological: R21/Matrix-M - single vial formulation · Biological: Licensed vaccine - Measles-rubella · Biological: Licensed vaccine - Yellow fever
150 participants, aged 6-7 months at the time of randomisation, who will receive a measles-rubella and yellow fever vaccination 2 months after randomisation.
Biological: Licensed vaccine - Measles-rubella · Biological: Licensed vaccine - Yellow fever
Group 4c is 50 participants, aged 6-7 months at the time of randomisation, who will receive 3 doses of 5µg R21/50µg Matrix-M one month apart.
Biological: R21/Matrix-M - single vial formulation
30 children who will receive 3 doses of 5µg R21/50µg Matrix-M, pentavalent, rotavirus, pneumococcal and OPV vaccines at 6, 10 and 14 weeks of age. They will receive IPV two weeks following the third dose.
Biological: R21/Matrix-M - single vial formulation · Biological: Licensed vaccine - Pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) · Biological: Licensed vaccine - Oral Polio Vaccine (OPV) · Biological: Licensed vaccine - Rotavirus · Biological: Licensed vaccine - Pneumococcal vaccine · Biological: Licensed vaccine - Inactivated Polio Vaccine (IPV)
30 children who will receive 3 doses of pentavalent, rotavirus, pneumococcal and OPV vaccines at 6, 10 and 14 weeks of age. They will receive IPV two weeks following the third dose.
Biological: Licensed vaccine - Pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) · Biological: Licensed vaccine - Oral Polio Vaccine (OPV) · Biological: Licensed vaccine - Rotavirus · Biological: Licensed vaccine - Pneumococcal vaccine · Biological: Licensed vaccine - Inactivated Polio Vaccine (IPV)
30 children, aged 5-36 months, who will receive 3 doses of 5µg R21/50µg Matrix-M. The first two doses one month apart and the third dose 6 months after the first dose.
Biological: R21/Matrix-M - single vial formulation
30 children, aged 5-36 months, who will receive 3 doses of 5µg R21/50µg Matrix-M. The first two doses one month apart and the third dose 12 months after the first dose.
Biological: R21/Matrix-M - single vial formulation
Adjuvanted malaria vaccine in a single vial formulation
Adjuvanted malaria vaccine in a double vial formulation
Licensed vaccine part of the EPI vaccination schedule
Licensed vaccine part of the EPI vaccination schedule
Licensed vaccine part of the EPI vaccination schedule
Licensed vaccine part of the EPI vaccination schedule
Licensed vaccine part of the EPI vaccination schedule
Licensed vaccine part of the EPI vaccination schedule
Licensed vaccine part of the EPI vaccination schedule
Safety
Solicited adverse events: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination. * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination. Unsolicited adverse events * Occurrence of unsolicited adverse events for 28 days following the vaccination. Laboratory adverse events * Change from baseline for safety laboratory measures thought to be clinically significant. Serious adverse events • Occurrence of serious adverse events for the whole study duration.
Time frame: 2 years
Immunogenicity
* To assess the humoral immunogenicity of R21/Matrix-M as a single- vial formulation in 5-36-month-old African children, compared with the two-vial formulation, 0, 30, 180 and 365 days after the administration of the third dose of R21/Matrix-M; and 0, 30, 180 and 365 days after the administration of a booster dose. * To assess the humoral immunogenicity of EPI vaccines given at 9 months, measles-rubella and yellow fever vaccines, when given with and without R21/Matrix-M, 0, 30, 180 and 360 days after the administration of the third dose of R21/Matrix-M * To assess the humoral immunogenicity of EPI vaccines given at 6, 10 and 14 weeks of age, pentavalent and oral polio vaccines, given as part of EPI at 6, 10 and 14 weeks of age, when given with and without R21/Matrix-M, 0, 30, 180 and 360 days after the administration of the third dose of R21/Matrix-M or the EPI vaccines.
Time frame: 2 years
Safety of a delayed third dose
Solicited adverse events: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination. * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination. Unsolicited adverse events * Occurrence of unsolicited adverse events for 28 days following the vaccination. Laboratory adverse events * Change from baseline for safety laboratory measures thought to be clinically significant. Serious adverse events • Occurrence of serious adverse events for the whole study duration.
Time frame: 2 years
Immunogenicity of a delayed third dose
• To assess the humoral immunogenicity of a delayed third dose of R21/Matrix-M in 5-36-month-old African children, at 30 and 180 days after administration of the second dose, and 0, 30, 180 and 360 days after the administration of the third dose of R21/Matrix-M
Time frame: 2 years
Plan to share: Undecided
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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