Infant Malaria Vaccine Schedule Optimization

Summary

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.

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, C, Y, W, X) polysaccharide conjugate vaccine

Administered by intramuscular injection. Each 0.5 mL dose contains 5 mcg of each Meningococcal A, C, Y, W, and X polysaccharide, 7.8 to 33.4 mcg of TT and 11.7 to 50.1 mcg of recombinant CRM197.

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.

Sponsors & Collaborators

• Pharmassist Ltd

  collaborator INDUSTRY

• Serum Institute of India Pvt. Ltd.

  collaborator INDUSTRY

• Agilis

  collaborator UNKNOWN

• MCT-CRO

  collaborator UNKNOWN

• Cytespace

  collaborator UNKNOWN

• PATH

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

42 Days

Max Age

49 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-30

Primary Completion

2027-09-27

Completion

2027-09-27

Countries

• Burkina Faso

Study Locations