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
This trial accepts healthy volunteersQualifiers
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 population
The study population will comprise children aged 5 months and above who live in R21-Malaria vaccine implementation areas in Uganda, Burkina Faso, Nigeria, Cote d'ivoire and who were eligible to have received R21-malaria vaccine based on their date of birth and age
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Case control study of clinical malaria
Other interventionCase control study of clinical malaria
Case control study of severe malaria
Other interventionCase control study of severe malaria
Case control study of death (all cause)
Other interventionCase control study of death (all cause)
Treatment groups
2,308 Participants
are divided into 3 treatment groupsGroup A: Case control study of Clinical malaria1 intervention
Group B: Case control study of Severe malaria1 intervention
Group C: Case control study of death (all cause)1 intervention
Trial outcomes
Primary outcomes
1
Vaccine Effectiveness against Severe Malaria caused by P. falciparum
Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.
Time frame
through study, an average of one year2
Vaccine Effectiveness against clinical malaria caused by P. falciparum in high perennial transmission areas
Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases caused by P. falciparum.
Time frame
through study, an average of one year3
Risk of death (all cause) due to R21-vaccination
Proportion of vaccinated and unvaccinated children in cases of death
Time frame
through study, an average of one yearSponsors and contacts
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Source ClinicalTrials.gov