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An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine

NCT07009847 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2308

Last updated 2025-08-13

No results posted yet for this study

Summary

This is an observational case-control study to assess the effectiveness of the R21/Matrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Clinical malaria, severe malaria and death (all-cause) cases will be enrolled in study. For each case (severe or death) 4 controls matched for age and neighborhood will be enrolled whereas for clinical malaria case, 1 matched control will be enrolled.

1. Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.
2. Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum.
3. Proportion of vaccinated and unvaccinated children in cases of death (all cause)
4. Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.

Conditions

  • Malaria,Falciparum
  • Morality

Interventions

OTHER

Case control study of clinical malaria

Case control study of clinical malaria

OTHER

Case control study of severe malaria

Case control study of severe malaria

OTHER

Case control study of death (all cause)

Case control study of death (all cause)

Sponsors & Collaborators

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Eligibility

Min Age
5 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2026-10-30
Completion
2026-12-31

Countries

  • Burkina Faso
  • Côte d’Ivoire
  • Nigeria
  • Uganda

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 NCT07009847 on ClinicalTrials.gov