Assessment of Safety and Immunogenicity of a Single Vial Presentation of R21/Matrix-M and Co-Administration With EPI Vaccines

Summary

This is a Phase Ib trial conducted in Bougouni, Mali to evaluate the safety and immunogenicity of R21/Matrix-M in a single and two vial presentation, with different immunisation schedules, and when co-administered with EPI vaccines in African children.

Conditions

• Malaria

Interventions

BIOLOGICAL

R21/Matrix-M - single vial formulation

Adjuvanted malaria vaccine in a single vial formulation

BIOLOGICAL

R21/Matrix-M - two vial formulation

Adjuvanted malaria vaccine in a double vial formulation

BIOLOGICAL

Licensed vaccine - Measles-rubella

Licensed vaccine part of the EPI vaccination schedule

BIOLOGICAL

Licensed vaccine - Yellow fever

Licensed vaccine part of the EPI vaccination schedule

BIOLOGICAL

Licensed vaccine - Pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib)

Licensed vaccine part of the EPI vaccination schedule

BIOLOGICAL

Licensed vaccine - Oral Polio Vaccine (OPV)

Licensed vaccine part of the EPI vaccination schedule

BIOLOGICAL

Licensed vaccine - Rotavirus

Licensed vaccine part of the EPI vaccination schedule

BIOLOGICAL

Licensed vaccine - Pneumococcal vaccine

Licensed vaccine part of the EPI vaccination schedule

BIOLOGICAL

Licensed vaccine - Inactivated Polio Vaccine (IPV)

Licensed vaccine part of the EPI vaccination schedule

Sponsors & Collaborators

• Malaria Research and Training Center, Bamako, Mali

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• Adrian Hill · University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

36 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-14

Primary Completion

2025-05-27

Completion

2025-05-27

Countries

• Mali
• United Kingdom

Study Locations