The overall objective of Tarsila Study is to estimate the real-world vaccine effectiveness of maternal RSVpreF immunization during pregnancy in Brazil against medically attended (inpatient and outpatient) respiratory syncytial virus-associated acute respiratory illness in infants. To achieve this, two multicenter, prospective, test-negative case-control studies will be conducted among infants with ARI: the TARSILA Inpatient Study, evaluating hospitalized infants and the TARSILA Outpatient Study, evaluating infants managed in outpatient settings.
Infant born in Brazil.
Mother resident in Brazil during the related pregnancy.
Infant date of birth 14 days or more after start of the first national RSVpreF vaccination campaign to ensure potential to have been born to an RSVpreF-vaccinated mother.
Infant ≤360 days of age at time of RSV specimen collection.
Maternal or infant receipt of any other licensed or investigational RSV preventive product.
Infant receipt of blood transfusion or other blood products containing antibodies since birth.
Infant previously enrolled in this study.
Lack of informed consent from the mother or the infant's legal guardian.
Inova Medical
Lead sponsor
Universidade Federal do Paraná
Collaborator