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

Recruiting Observational Study
Malaria,Falciparum Morality
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
5 Months and older
Sex
Any
Study type
Observational
Participants needed
2,308 (estimated)
Sponsor
Serum Institute of India Pvt. Ltd. · Industry
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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 contr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: For Cases- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. 2 Parent/legal guardian/ caregiver of the child willing to provide the written informed consent for their child's participation in the study. 3 Parent/legal guardian/ caregiver willin…
Contacts

Dr. Prasad Kulkarni, MD, FRCP

+91-20-7194-6820

drpsk@seruminstitute.com

CONTACT

Dr. Sandesh M Bharati, MD

+91- 20-7194-6825

sandesh.bharati@seruminstitute.com

CONTACT