Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
375 participants
INTERVENTIONAL
2026-03-01
2026-12-31
Brief Summary
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All participants will receive the same number of injections and will be randomly assigned to receive one of the followings:
1. The standard dose (10μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11 (n=125).
or
2. A half dose (5μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11.
If participant receive the half dose, it will come from one of two types of vaccine:
2a. 10 dose vials with adaptor Preservative Free (n=125) 2b. 10 dose vials with 2PE Preservative (n=125)
Clinical procedure for participants:
* Standardized symptom questionnaire
* Physical examination:
* Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature.
* Spleen and liver size will be recorded if palpable.
* Pregnancy test (for female of child bearing potential)
* Venous blood collection (Pre-vaccination) 3mL
* Vaccination
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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The standard adult vaccine dose
Adults and adolescents receiving the standard adult vaccine dose
10μg R21/50μg Matrix-M
Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)
A half of the standard adult vaccine dose with adaptor Preservative Free
Adults and adolescents receiving a half of the standard adult vaccine dose with adaptor Preservative Free (n=125)
5μg R21/50μg Matrix-M with adaptor preservative free
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125)
A half of the standard adult vaccine dose with 2PE Preservative
Adults and adolescents receiving a half of the standard adult vaccine dose with 2PE Preservative (n=125)
5μg R21/50μg Matrix-M with 2PE preservative
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125)
Interventions
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10μg R21/50μg Matrix-M
Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)
5μg R21/50μg Matrix-M with adaptor preservative free
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125)
5μg R21/50μg Matrix-M with 2PE preservative
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125)
Eligibility Criteria
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Inclusion Criteria
* Age 14 years to 60 years.
* Written informed consent/assent provided by participants (or a parent/guardian in case the participant is under 18 years old).
Exclusion Criteria
* Acute illness requiring intervention.
* A history of an adverse reaction to study vaccine.
* Prior receipt of any other malaria vaccine.
* Enrolment in another intervention trial in the last month.
* Planned enrolment in another intervention trial in the coming 12 months.
* Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and/or planned for the coming 12 months.
14 Years
60 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Locations
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Lama Upazila Health Complex
Lāma, Lama, Bangladesh
Alikadam Upazila Health Complex
Bāndarban, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MAL25005
Identifier Type: -
Identifier Source: org_study_id
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