Dose Finding Trial of R21/Matrix-M in School Children

Exclusion Criteria12

• The child is enrolled in another malaria vaccine trial.
• The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria 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 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 investigational 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.