Health Trials

Infant Malaria Vaccine Schedule Optimization

ConditionMalaria Vaccines
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age42-49
SponsorPATH

About this trial

The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.

Eligibility criteria

Qualifiers

Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent/legal guardian of the infant.

Infants must have been born full-term (at ≥37 weeks of gestation) and > 2500 grams at birth.

Immunization schedule Cohorts 1, 2, and 3: Male and female infants 42-49 days (inclusive) of age at time of enrollment.

Prior to group randomization, for infants in Cohort 1 randomization to receive vaccine dose 1 (Groups 1 and 2 of R21/MM or placebo, respectively) will occur at 42-49 days of age. Infants in Cohorts 2 and 3 will not be randomized to R21/MM or placebo; placebo will no longer be given. Rather infants in these cohorts will receive open-label R21/MM according to the immunization schedule category to which they have been randomized. Infants in Cohort 2, will receive their open-label R21/MM vaccine dose 1 (Group 3) at 2 months (56-63 days of age). Infants in Cohort 3, will receive their open-label R21/MM vaccine dose 1 (Group 5) at 3 months (84-91 days of age).

Disqualifiers

Clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests 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.

At time of enrollment, any infant who has received any dose of the hexavalent/pentavalent vaccines, pneumococcal vaccine, rotavirus vaccine, IPV or has received more than one dose of oral polio virus or more than one dose of hepatitis B vaccine.

Weight-for-length/height Z score of less than -3 or other clinical signs of malnutrition.

Infant with major congenital defects.

Trial design

Treatments tested in this trial

  • R21 Matrix-M (R21/MM) Malaria Vaccine
  • Placebo
  • Hexavalent Vaccine
  • Pneumococcal Polysaccharide Conjugate Vaccine
  • Rotavirus, Live Attenuated (Oral) Vaccine
  • Measles and Rubella Vaccine
  • Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine
  • Yellow Fever vaccine
  • Typhoid Conjugate vaccine

Treatment groups

964 Participants
are divided into 4 treatment groups

Sponsors and collaborators

PATH

Lead sponsor

Pharmassist Ltd

Collaborator

Serum Institute of India Pvt. Ltd.

Collaborator

Agilis

Collaborator

MCT-CRO

Collaborator

Cytespace

Collaborator

Source ClinicalTrials.gov