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Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso

2019-04-04 09:20:42 | BioPortfolio

Summary

This is a double blind randomised controlled clinical trial to evaluate the efficacy of R21 adjuvanted with Matrix-M in healthy 5-17 month old children in a malaria endemic area.

Description

Participants will be randomised 2:1 to receive vaccination with the IMP (R21 adjuvanted with Matrix-M; Group 1) or control vaccination with Rabies Vaccine (Group 2). Participants and investigators will be blinded to group allocation for each participant. Efficacy of vaccination will be assessed by comparing the development of malaria between Groups 1 versus Group 2 participants.

There are two study vaccines: the IMP, R21 adjuvanted with Matrix-M; and Rabies Vaccine. Group 1 (active vaccine group) participants will receive 3 vaccinations of R21 5μg with 50μg Matrix-M, 4 weeks apart via the intramuscular route.

Group 2 (control group) participants will receive three vaccinations with rabies vaccine, four weeks apart, all given intramuscularly.

Study Design

Conditions

Malaria,Falciparum

Intervention

R21 adjuvanted with 25mcg Matrix-M, Rabies Vaccine, R21 adjuvanted with 50mcg Matrix-M

Status

Not yet recruiting

Source

University of Oxford

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-04-04T09:20:42-0400

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