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Assessing Vaccine Effectiveness of R21/Matrix-M Across Malaria Transmission Settings (AVERT)
Sponsor: Clinton Health Access Initiative Inc.
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.
Official title: Real-World Effectiveness of the R21/Matrix-M Malaria Vaccine in Children in Burkina Faso and Uganda
Key Details
Gender
All
Age Range
5 Months - 5 Years
Study Type
OBSERVATIONAL
Enrollment
20000
Start Date
2026-07-14
Completion Date
2027-08
Last Updated
2026-08-06
Healthy Volunteers
No
Conditions
Interventions
R21/Matris-M Malaria vaccine
R21/Matrix-M vaccination received through routine national immunization programs. The study will record the number and dates of doses received. Children will be classified as having received 0, 1, 2, 3, or 4 eligible doses, with prespecified grouped classifications used if individual dose categories are underpowered. Doses given fewer than 14 days before malaria testing will not count toward the primary exposure classification.
Locations (21)
Boromo urbain 1
Boromo, Boucle Mouhoun, Burkina Faso
Ouahabou
Boromo, Boucle Mouhoun, Burkina Faso
Béréba
Houndé, Hauts-Bassins Region, Burkina Faso
Dohoun
Houndé, Hauts-Bassins Region, Burkina Faso
Kari
Houndé, Hauts-Bassins Region, Burkina Faso
Déguélin
Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso
Karangasso-Vigué
Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso
Sourmousso
Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso
Wara
Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso
Mankarga T
Zorgo, Oubri, Burkina Faso
Mankarga V3
Zorgo, Oubri, Burkina Faso
Mankarga V6
Zorgo, Oubri, Burkina Faso
Kitgum-Matidi HCIII
Kitgum, Acholi, Uganda
Namokora HCIV
Kitgum, Acholi, Uganda
Lalogi HCIV
Omoro, Acholi, Uganda
Rwenyawawa HCIII
Kikube, Bunyoro, Uganda
Nawaikoke HCIII
Kaliro, Busoga, Uganda
Kigandalo HCIV
Mayuge, Busoga, Uganda
Nadunget HCIII
Moroto, Karamoja, Uganda
Orum HCIV
Otuke, Lango, Uganda
Otwal HCIII
Oyam, Lango, Uganda