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Real-World Effectiveness of the R21/Matrix-M Malaria Vaccine in Children in Burkina Faso and Uganda

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Biological
Study Type: Observational
SUMMARY

The AVERT study is a prospective observational test-negative case control study evaluating the real-world effectiveness of the R21/Matrix-M malaria vaccine among children younger than 5 years in Burkina Faso and Uganda. Children who seek outpatient care with suspected malaria and are eligible for the national R21/Matrix-M vaccination program will be enrolled. Malaria infection will be determined by blood smear microscopy. Children with a positive microscopy result will be classified as cases and children with a negative result as controls. Vaccination history, including the number and timing of doses, will be obtained primarily from vaccination cards or other written records. Vaccine effectiveness will be estimated by comparing the odds of vaccination among cases and controls.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 5
Healthy Volunteers: f
View:

• Residence in an area where R21/Matrix-M is implemented and within the catchment area of a selected study facility.

• Younger than 5 years and eligibleto receive R21/Matrix-M under the national vaccination schedule at rollout.

• Meets the country definition of suspected malaria, generally axillary temperature of at least 37.5 degrees Celsius or a history of fever within the previous 24 hours, and is undergoing malaria testing.

• Written informed consent provided by an adult caregiver aged 18 years or older.

Locations
Other Locations
Burkina Faso
Boromo urbain 1
RECRUITING
Boromo
Ouahabou
RECRUITING
Boromo
Béréba
RECRUITING
Houndé
Dohoun
RECRUITING
Houndé
Kari
RECRUITING
Houndé
Déguélin
RECRUITING
Karangasso-vigué
Karangasso-Vigué
RECRUITING
Karangasso-vigué
Sourmousso
RECRUITING
Karangasso-vigué
Wara
RECRUITING
Karangasso-vigué
Mankarga T
RECRUITING
Zorgo
Mankarga V3
RECRUITING
Zorgo
Mankarga V6
RECRUITING
Zorgo
Uganda
Nawaikoke HCIII
NOT_YET_RECRUITING
Kaliro
Rwenyawawa HCIII
NOT_YET_RECRUITING
Kikube
Kitgum-Matidi HCIII
NOT_YET_RECRUITING
Kitgum
Namokora HCIV
NOT_YET_RECRUITING
Kitgum
Kigandalo HCIV
NOT_YET_RECRUITING
Mayuge
Nadunget HCIII
NOT_YET_RECRUITING
Moroto
Lalogi HCIV
NOT_YET_RECRUITING
Omoro
Orum HCIV
NOT_YET_RECRUITING
Otuke
Otwal HCIII
NOT_YET_RECRUITING
Oyam
Time Frame
Start Date: 2026-07-14
Estimated Completion Date: 2027-08
Participants
Target number of participants: 20000
Treatments
Suspected malaria cases that test positive using microscopy
Eligible children with suspected malaria whose enrollment blood smear microscopy result is positive for P. falciparum infection
Suspected malaria cases that test negative using microscopy
Eligible children with suspected malaria whose enrollment blood smear microscopy result is negative for P. falciparum infection
Related Therapeutic Areas
Sponsors
Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso, Ministry of Health, Uganda, Ministry of Health, Burkina Faso, Infectious Diseases Research Collaboration, Uganda, University of California, San Francisco
Leads: Clinton Health Access Initiative Inc.

This content was sourced from clinicaltrials.gov