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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 5 of 5 sites
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07009847
Lead Sponsor Serum Institute of India Pvt. Ltd.
Conditions
(from sponsor)		 Malaria,Falciparum, Morality
Related terms Death, Malaria, Malaria, Falciparum
Enrollment 2,308 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov