Infant Malaria Vaccine Schedule Optimization

NCT ID: NCT06879327

Last Updated: 2025-08-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2028-03-22

Brief Summary

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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.

Detailed Description

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The R21/Matrix-M (R21/MM) vaccine has been recommended by the World Health Organization (WHO) to prevent clinical malaria in young children living in moderate to high transmission areas of Sub-Saharan Africa. R21/MM is based on the circumsporozoite protein (CSP) targeting the pre-erythrocytic stage of Plasmodium falciparum. R21/MM elicits high levels of antibodies against the central repeat (Asn-Ala-Asn-Pro \[NANP\]) of the circumsporozoite protein (CSP) which has been shown to correlate with protection. Currently, R21/MM is recommended to be delivered to young children starting at 5-6 months of age with 3 doses given at monthly intervals, however, there are no existing Essential Programme on Immunization (EPI) vaccine visits scheduled at these ages.

We plan to evaluate, using the R21/MM malaria vaccine as a model system, how age at first vaccine dose and time intervals between doses modify the immunogenicity of the vaccine and the ensuant efficacy in protecting infants against clinical Plasmodium falciparum malaria.

Healthy male or female infants 6 to 7 weeks of age will be randomized to one of three different immunization schedule cohorts: a) a "compressed" conventional schedule at 6-10-14 weeks of age; b) a "relaxed" schedule at 2-4-6 months of age; c) a "relaxed" schedule at 3-6-9 months of age. Participants in each immunization schedule cohort will be randomized in a ratio of 3:1 to receive 4 doses of either R21/MM or placebo with a 4th dose to be administered at 15 months of age.

Infants randomized to the respective immunization schedule categories will receive co-administered routine EPI vaccines. The study will include the provision of a three dose R21/MM compressed schedule to all participants randomized to the placebo arms upon completion of the study at Month 27 of life.

Conditions

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Malaria Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
1200 healthy participants will be randomized to an immunization schedule cohort if eligibility is confirmed by the investigator(s) at 42 to 49 days of age. The investigators and parent/legal guardian will both know which immunization schedule cohort their infant has been assigned to.

Infants will be randomized within each immunization schedule category to a group assignment to either receive the R21/MM or placebo; neither the blinded study staff nor the parent/legal guardian will know whether the infant will receive the R21/MM or placebo.

Study Groups

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Compressed 6-10-14 Week Schedule: R21/MM Malaria Vaccine

Participants will receive R21/MM malaria vaccination at 6, 10, and 14 weeks of age, co-administered with hexavalent vaccine, pneumococcal conjugate vaccine (PCV), and oral rotavirus vaccine (RV). At 9 months of age participants will receive measles-rubella (MR) vaccine, yellow fever (YF) vaccine, and typhoid conjugate vaccine (TCV).

Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the 2nd dose of measles-rubella vaccine and meningococcal A conjugate vaccine (MenA).

Group Type EXPERIMENTAL

R21 Matrix-M (R21/MM) Malaria Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains R21 Malaria Antigen (5 mcg) and Matrix-M1 (Adjuvant) (50 mcg).

Hexavalent Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose of 0.5 mL contains:

* Diphtheria Toxoid \> 30 IU
* Tetanus Toxoid \> 40 IU
* B. pertussis (whole cell) \> 4 IU
* Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg
* Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU
* Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\]

Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.

Rotavirus, Live Attenuated (Oral) Vaccine

Intervention Type BIOLOGICAL

Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \[G1, G2, G3, G4 and G9\], 5.6 focus-forming units (FFU) / serotype.

Measles and Rubella Vaccine

Intervention Type BIOLOGICAL

Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.

Meningococcal A conjugate vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains Meningococcal A polysaccharide 10 mcg and tetanus toxoid (TT) (carrier protein) 10 to 33 mcg.

Yellow Fever vaccine

Intervention Type BIOLOGICAL

Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Typhoid Conjugate vaccine

Intervention Type BIOLOGICAL

Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Compressed 6-10-14 Week Schedule: Placebo

Participants will receive placebo at 6, 10, and 14 weeks of age, co-administered with hexavalent vaccine, PCV, and oral RV. At 9 months of age participants will receive MR and YF vaccines, and TCV.

Participants will receive a booster dose of placebo at 15 months of age co-administered with the 2nd dose of MR vaccine and MenA vaccine.

Participants will receive R21/MM malaria vaccination at 27, 28, and 29 months of age (after completion of the study).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose (0.5 mL) contains Normal saline (0.9%).

Hexavalent Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose of 0.5 mL contains:

* Diphtheria Toxoid \> 30 IU
* Tetanus Toxoid \> 40 IU
* B. pertussis (whole cell) \> 4 IU
* Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg
* Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU
* Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\]

Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.

Rotavirus, Live Attenuated (Oral) Vaccine

Intervention Type BIOLOGICAL

Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \[G1, G2, G3, G4 and G9\], 5.6 focus-forming units (FFU) / serotype.

Measles and Rubella Vaccine

Intervention Type BIOLOGICAL

Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.

Meningococcal A conjugate vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains Meningococcal A polysaccharide 10 mcg and tetanus toxoid (TT) (carrier protein) 10 to 33 mcg.

Yellow Fever vaccine

Intervention Type BIOLOGICAL

Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Typhoid Conjugate vaccine

Intervention Type BIOLOGICAL

Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Relaxed 2-4-6 Month Schedule: R21/MM Malaria Vaccine

Participants will receive R21/MM malaria vaccination at 2, 4, and 6 months of age co-administered with hexavalent vaccine, PCV, and oral RV. At 9 months of age participants will receive MR and YF vaccines and TCV.

Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the 2nd dose of MR vaccine and MenA vaccine.

Group Type EXPERIMENTAL

R21 Matrix-M (R21/MM) Malaria Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains R21 Malaria Antigen (5 mcg) and Matrix-M1 (Adjuvant) (50 mcg).

Hexavalent Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose of 0.5 mL contains:

* Diphtheria Toxoid \> 30 IU
* Tetanus Toxoid \> 40 IU
* B. pertussis (whole cell) \> 4 IU
* Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg
* Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU
* Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\]

Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.

Rotavirus, Live Attenuated (Oral) Vaccine

Intervention Type BIOLOGICAL

Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \[G1, G2, G3, G4 and G9\], 5.6 focus-forming units (FFU) / serotype.

Measles and Rubella Vaccine

Intervention Type BIOLOGICAL

Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.

Meningococcal A conjugate vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains Meningococcal A polysaccharide 10 mcg and tetanus toxoid (TT) (carrier protein) 10 to 33 mcg.

Yellow Fever vaccine

Intervention Type BIOLOGICAL

Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Typhoid Conjugate vaccine

Intervention Type BIOLOGICAL

Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Relaxed 2-4-6 Month Schedule: Placebo

Participants will receive placebo at 2, 4, and 6 months of age co-administered with hexavalent vaccine, PCV, and oral RV. At 9 months of age participants will receive MR and YF vaccines, and TCV.

Participants will receive a booster dose of placebo at 15 months of age co-administered with the 2nd dose of MR vaccine and MenA vaccine.

Participants will receive R21/MM malaria vaccination at 27, 28, and 29 months of age (after completion of the study).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose (0.5 mL) contains Normal saline (0.9%).

Hexavalent Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose of 0.5 mL contains:

* Diphtheria Toxoid \> 30 IU
* Tetanus Toxoid \> 40 IU
* B. pertussis (whole cell) \> 4 IU
* Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg
* Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU
* Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\]

Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.

Rotavirus, Live Attenuated (Oral) Vaccine

Intervention Type BIOLOGICAL

Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \[G1, G2, G3, G4 and G9\], 5.6 focus-forming units (FFU) / serotype.

Measles and Rubella Vaccine

Intervention Type BIOLOGICAL

Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.

Meningococcal A conjugate vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains Meningococcal A polysaccharide 10 mcg and tetanus toxoid (TT) (carrier protein) 10 to 33 mcg.

Yellow Fever vaccine

Intervention Type BIOLOGICAL

Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Typhoid Conjugate vaccine

Intervention Type BIOLOGICAL

Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Relaxed 3-6-9 Month Schedule: R21/MM Malaria Vaccine

Participants will receive R21/MM malaria vaccination at 3, 6, and 9 months of age. Participants will receive the hexavalent vaccine, PCV, and oral RV at 6 weeks, 10 weeks, and 3 months of age. At 9 months of age participants will receive MR and YF vaccines and TCV.

Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the 2nd dose of MR vaccine and the MenA vaccine.

Group Type EXPERIMENTAL

R21 Matrix-M (R21/MM) Malaria Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains R21 Malaria Antigen (5 mcg) and Matrix-M1 (Adjuvant) (50 mcg).

Hexavalent Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose of 0.5 mL contains:

* Diphtheria Toxoid \> 30 IU
* Tetanus Toxoid \> 40 IU
* B. pertussis (whole cell) \> 4 IU
* Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg
* Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU
* Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\]

Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.

Rotavirus, Live Attenuated (Oral) Vaccine

Intervention Type BIOLOGICAL

Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \[G1, G2, G3, G4 and G9\], 5.6 focus-forming units (FFU) / serotype.

Measles and Rubella Vaccine

Intervention Type BIOLOGICAL

Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.

Meningococcal A conjugate vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains Meningococcal A polysaccharide 10 mcg and tetanus toxoid (TT) (carrier protein) 10 to 33 mcg.

Yellow Fever vaccine

Intervention Type BIOLOGICAL

Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Typhoid Conjugate vaccine

Intervention Type BIOLOGICAL

Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Relaxed 3-6-9 Month Schedule: Placebo

Participants will receive placebo at 3, 6, and 9 months of age. Participants will receive the hexavalent vaccine, PCV, and oral RV at 6 weeks, 10 weeks, and 3 months of age. At 9 months of age participants will receive MR and YF vaccines and TCV.

Participants will receive a booster dose of placebo at 15 months of age co-administered with the 2nd dose of MR vaccine and the MenA vaccine.

Participants will receive R21/MM malaria vaccination at 27, 28, and 29 months of age (after completion of the study).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose (0.5 mL) contains Normal saline (0.9%).

Hexavalent Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each dose of 0.5 mL contains:

* Diphtheria Toxoid \> 30 IU
* Tetanus Toxoid \> 40 IU
* B. pertussis (whole cell) \> 4 IU
* Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg
* Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU
* Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\]

Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.

Rotavirus, Live Attenuated (Oral) Vaccine

Intervention Type BIOLOGICAL

Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \[G1, G2, G3, G4 and G9\], 5.6 focus-forming units (FFU) / serotype.

Measles and Rubella Vaccine

Intervention Type BIOLOGICAL

Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.

Meningococcal A conjugate vaccine

Intervention Type BIOLOGICAL

Administered by intramuscular injection. Each 0.5 mL dose contains Meningococcal A polysaccharide 10 mcg and tetanus toxoid (TT) (carrier protein) 10 to 33 mcg.

Yellow Fever vaccine

Intervention Type BIOLOGICAL

Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Typhoid Conjugate vaccine

Intervention Type BIOLOGICAL

Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Interventions

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R21 Matrix-M (R21/MM) Malaria Vaccine

Administered by intramuscular injection. Each 0.5 mL dose contains R21 Malaria Antigen (5 mcg) and Matrix-M1 (Adjuvant) (50 mcg).

Intervention Type BIOLOGICAL

Placebo

Administered by intramuscular injection. Each dose (0.5 mL) contains Normal saline (0.9%).

Intervention Type BIOLOGICAL

Hexavalent Vaccine

Administered by intramuscular injection. Each dose of 0.5 mL contains:

* Diphtheria Toxoid \> 30 IU
* Tetanus Toxoid \> 40 IU
* B. pertussis (whole cell) \> 4 IU
* Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg
* Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU
* Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\]

Intervention Type BIOLOGICAL

Pneumococcal Polysaccharide Conjugate Vaccine

Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.

Intervention Type BIOLOGICAL

Rotavirus, Live Attenuated (Oral) Vaccine

Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \[G1, G2, G3, G4 and G9\], 5.6 focus-forming units (FFU) / serotype.

Intervention Type BIOLOGICAL

Measles and Rubella Vaccine

Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.

Intervention Type BIOLOGICAL

Meningococcal A conjugate vaccine

Administered by intramuscular injection. Each 0.5 mL dose contains Meningococcal A polysaccharide 10 mcg and tetanus toxoid (TT) (carrier protein) 10 to 33 mcg.

Intervention Type BIOLOGICAL

Yellow Fever vaccine

Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Intervention Type BIOLOGICAL

Typhoid Conjugate vaccine

Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.

Intervention Type BIOLOGICAL

Other Intervention Names

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HEXASIIL PNEUMOSIL ROTASIIL MenAfriVac

Eligibility Criteria

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Inclusion Criteria

* 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. 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. For infants in Cohort 2, randomization to receive vaccine dose 1 (Groups 3 and 4 of R21/MM or placebo, respectively) will occur at 2 months (56-63 days of age). For infants in Cohort 3, randomization to receive vaccine dose 1 (Groups 5 and 6 of R21/MM or placebo, respectively) will occur at 3 months (84-91 days of age).
* The participant's parent/guardian must be willing to avoid travel, particularly in the 28 days after each study vaccination, must confirm willingness to contact the study team in the event of unexpected/unavoidable travel and, for the safety cohort, must confirm availability for the home visits to be conducted by a field worker to collect solicited AEs over the 7 days (day of vaccination and 6 subsequent days) following each study vaccine.
* The participant's parent/guardian must confirm willingness to bring their child to the study clinic / local health care clinic, and capacity to contact the study team in the event the subject has any illnesses or other health concerns during the study.
* Participants who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol (e.g. return for follow-up visits) may be enrolled in the study.

Exclusion Criteria

* Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to participants with a minor illness such as diarrhea, mild upper respiratory infection, without low-grade febrile illness, i.e. axillary temperature \< 37.5°C).
* 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-height/length Z score of less than -3 or other clinical signs of malnutrition.
* Infant with major congenital defects.
* The infant has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Any confirmed or suspected immunosuppressive or immunodeficient state (including HIV or asplenia) or known maternal HIV infection (no HIV testing will be routinely done by the study team).
* Administration of immunoglobulins and/or any blood products/blood transfusion from birth to time of planned administration of the vaccine candidate.
* Previous vaccination of participant or biological mother with a malaria vaccine.
* Participation in another research study involving receipt of an investigational product or planned use during the study period.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Minimum Eligible Age

42 Days

Maximum Eligible Age

49 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Serum Institute of India PVT LTD (SII)

UNKNOWN

Sponsor Role collaborator

Agilis

UNKNOWN

Sponsor Role collaborator

Pharmassist Ltd

INDUSTRY

Sponsor Role collaborator

MCT-CRO

UNKNOWN

Sponsor Role collaborator

Cytespace

UNKNOWN

Sponsor Role collaborator

PATH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Recherche en Science de la Santé (IRSS)

Bobo-Dioulasso, , Burkina Faso

Site Status RECRUITING

Groupe de Recherche Action en Santé (GRAS)

Ouagadougou, , Burkina Faso

Site Status RECRUITING

Countries

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Burkina Faso

Central Contacts

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Michael Thigpen, MD

Role: CONTACT

+1 202 822 0033

Facility Contacts

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Issaka Zongo, MD, PhD

Role: primary

226 70 78 22 74

Sodiomon Sirima, MD, BA, PhD

Role: primary

226 25 35 56 90

Other Identifiers

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CVIA 108

Identifier Type: -

Identifier Source: org_study_id

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