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Dose Finding Trial of R21/Matrix-M in School Children

NCT07074665 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-23

No results posted yet for this study

Summary

This trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso.

Participants (n=30-40) who have previously received four doses of the 5µg R21/50µg Matrix-M malaria vaccine in VAC 076 will be randomised to receive either 5µg R21/50µg Matrix-M or 10µg R21/50µg Matrix-M. Safety and immunogenicity of a booster at school age at these two different doses will be assessed. Participants will be followed up for one year after the booster.

Conditions

  • Malaria (Plasmodium Falciparum)

Interventions

BIOLOGICAL

5µg R21/50µg Matrix-M

R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. The standard paediatric dose is 5µg R21/50µg Matrix-M.

BIOLOGICAL

10µg R21/50µg Matrix-M

R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. 10µg R21/50µg Matrix-M is the standard adult dose.

Sponsors & Collaborators

  • Institut de Recherche en Sciences de la Sante, Burkina Faso

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-18
Primary Completion
2026-04-30
Completion
2027-03-31

Countries

  • Burkina Faso

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07074665 on ClinicalTrials.gov