Infant Malaria Vaccine Schedule Optimization

PHASE2RecruitingINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

May 30, 2025

Primary Completion Date

March 22, 2028

Study Completion Date

March 22, 2028

Conditions
Malaria Vaccines
Interventions
BIOLOGICAL

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).

BIOLOGICAL

Placebo

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

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\]"

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.

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.

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.

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.

BIOLOGICAL

Yellow Fever vaccine

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

BIOLOGICAL

Typhoid Conjugate vaccine

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

Trial Locations (2)

Unknown

RECRUITING

Institut de Recherche en Science de la Santé (IRSS), Bobo-Dioulasso

RECRUITING

Groupe de Recherche Action en Santé (GRAS), Ouagadougou

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Serum Institute of India PVT LTD (SII)

UNKNOWN

collaborator

Agilis

UNKNOWN

collaborator

Pharmassist Ltd

INDUSTRY

collaborator

MCT-CRO

UNKNOWN

collaborator

Cytespace

UNKNOWN

lead

PATH

OTHER