Observational Case-Control Study to Evaluate the Effectiveness and Safety of the R21Matrix-M Malaria Vaccine in Children

What this Trial Is About

Researchers are conducting an observational case-control study to evaluate the effectiveness and safety of the R21Matrix-M vaccine in preventing severe malaria, clinical malaria in high transmission areas, and to assess if vaccinated children have an increased risk of death from any cause. The study focuses on children eligible for the vaccine, comparing vaccinated and unvaccinated groups to understand vaccine impact on malaria and mortality. Cases of severe malaria, clinical malaria, and death will be enrolled along with matched controls based on age and neighborhood. The study is carried out at multiple centers across countries where the R21Matrix-M vaccine is approved and used. Cases are recruited from hospitals, clinics, or the community depending on the condition, while controls are matched from the same neighborhood but different households. For severe malaria and death cases, four controls per case are enrolled, and for clinical malaria cases, there is a one-to-one control ratio. Vaccination status is verified through records or caregiver history. Laboratory tests confirm malaria diagnosis as per specific case definitions. Participants will be children aged 5 months and older living in vaccine deployment areas. Researchers will collect medical and vaccination data, including hospital records and home visits when needed. The study will measure vaccine effectiveness against severe and clinical malaria caused by P. falciparum over about one year and assess the risk of death. Surveillance includes hospital and community case detection, with follow-up data collection from families and healthcare providers. The study aims to provide thorough monitoring of outcomes related to malaria and overall mortality.

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