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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorSerum Institute of India Pvt. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.

Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).

Received one or more doses of RTS,S/AS01 vaccine in the past.

Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.

Trial design

Treatments tested in this trial

  • Case control study of clinical malaria
  • Case control study of severe malaria
  • Case control study of death (all cause)

Treatment groups

2,308 Participants
are divided into 3 treatment groups