Status:

NOT_YET_RECRUITING

R21/MM Dosing, Presentations, and Preservatives

Lead Sponsor:

University of Oxford

Conditions:

Plasmodium Falciparum Malaria

Malaria

Eligibility:

All Genders

14-60 years

Phase:

PHASE4

Brief Summary

This is a single blind randomised controlled trial. This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in child and adults. The results ...

Eligibility Criteria

Inclusion

  • Residence in a study village for the study period, i.e. 12 months.
  • Age 14 years to 60 years.
  • Written informed consent/assent provided by participants (or a parent/guardian in case the participant is under 18 years old).

Exclusion

  • Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.
  • Acute illness requiring intervention.
  • A history of an adverse reaction to study vaccine.
  • Prior receipt of any other malaria vaccine.
  • Enrolment in another intervention trial in the last month.
  • Planned enrolment in another intervention trial in the coming 12 months.
  • Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and/or planned for the coming 12 months.

Key Trial Info

Start Date :

December 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

375 Patients enrolled

Trial Details

Trial ID

NCT07194668

Start Date

December 1 2025

End Date

December 31 2026

Last Update

November 19 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Lama Upazila Health Complex

Lāma, Lama, Bangladesh, 4641

2

Alikadam Upazila Health Complex

Bāndarban, Bangladesh, 4650