1,200
Participants
Start Date
May 30, 2025
Primary Completion Date
March 22, 2028
Study Completion Date
March 22, 2028
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).
Placebo
Administered by intramuscular injection. Each dose (0.5 mL) contains Normal saline (0.9%).
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\]"
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.
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.
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.
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.
Yellow Fever vaccine
Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.
Typhoid Conjugate vaccine
Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.
RECRUITING
Institut de Recherche en Science de la Santé (IRSS), Bobo-Dioulasso
RECRUITING
Groupe de Recherche Action en Santé (GRAS), Ouagadougou
Collaborators (2)
Serum Institute of India PVT LTD (SII)
UNKNOWN
Agilis
UNKNOWN
Pharmassist Ltd
INDUSTRY
MCT-CRO
UNKNOWN
Cytespace
UNKNOWN
PATH
OTHER