SERVAL

Seasonal R21 mass vaccination for malaria elimination (SERVAL)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202404544467702

Enrollment

16200

Registered

2024-04-10

Start date

2024-04-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

R21Matrix M

No intervention

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age= 5 months. 2. Willingness to comply with trial procedures. 3. Individual written informed consent obtained at the beginning of the study.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone. 3. Any history of anaphylaxis in relation to vaccination. 4. Known chronic illness. 5. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.

Design outcomes

Primary

Measure	Time frame
Prevalence of malaria infection by molecular methods in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses.	—

Secondary

Measure	Time frame
1. Occurrence of Adverse events (AEs) and serious adverse events (SAEs) during follow up. 2. Incidence of malaria infection in all age groups during the transmission season following mass vaccination with R21. 3. Prevalence of malaria infection by molecular methods in all age groups at peak transmission following the booster dose. 4. Incidence of malaria infection in all age groups during the transmission season following the booster dose. 5. Incidence of clinical malaria in all age groups following the booster dose. 6. Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses. 7. Coverage of the booster dose. 8. Cost of vaccine administration, both for the mass vaccination campaign with 3 doses and the booster dose. 9. Incremental cost-effectiveness. ;Secondary outcome - Exploratory outcomes Prevalence of serological markers (AMA-1, MSP-1, GLURP, GexP, RH2030 and Etramp5.Ag1) at peak transmission after mass vaccination campaign with 3 doses and the booster dose.	—

Measure

Time frame

1. Occurrence of Adverse events (AEs) and serious adverse events (SAEs) during follow up. 2. Incidence of malaria infection in all age groups during the transmission season following mass vaccination with R21. 3. Prevalence of malaria infection by molecular methods in all age groups at peak transmission following the booster dose. 4. Incidence of malaria infection in all age groups during the transmission season following the booster dose. 5. Incidence of clinical malaria in all age groups following the booster dose. 6. Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses. 7. Coverage of the booster dose. 8. Cost of vaccine administration, both for the mass vaccination campaign with 3 doses and the booster dose. 9. Incremental cost-effectiveness. ;Secondary outcome - Exploratory outcomes Prevalence of serological markers (AMA-1, MSP-1, GLURP, GexP, RH2030 and Etramp5.Ag1) at peak transmission after mass vaccination campaign with 3 doses and the booster dose.

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Countries

Burkina Faso, Gambia

Contacts

Public ContactUmberto D Alessandro

MRC Unit The Gambia at LSHTN

Umberto.Dalessandro@lshtm.ac.uk+2204495443

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026