A Phase III Randomized Controlled Multi-centre Trial to Evaluate the Efficacy of the R21/Matrix-M Vaccine in African Children Against Clinical Malaria

VAC078

A Phase III randomized controlled multi-centre trial to evaluate the efficacy of the R21/Matrix-M vaccine in African children against clinical malaria

2021-04-29

2023-03-21

2026-03-01

Active (not recruiting)

Early phase I

4800

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).

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2024-05-17