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NCT07445763

TARSILA Real-World Evidence Study

Sponsor: Inova Medical

View on ClinicalTrials.gov

Summary

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.

Official title: Real-world Effectiveness of maTernAl RSVpreF vaccInation Against RSV-associated Acute Respiratory ilLness in Infants in BrAzil (TARSILA Study): a Multicentre, Prospective, Test-negative, Case-Control Study

Key Details

Gender

All

Age Range

0 Days - 360 Days

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2026-04-30

Completion Date

2028-12-31

Last Updated

2026-03-03

Healthy Volunteers

Conditions

Respiratory Syncytial Virus (RSV)Maternal Immunization Acute Respiratory Illness (ARI)Lower Respiratory Tract Disease Infant Outcomes

Interventions

BIOLOGICAL

respiratory syncytial virus bivalent prefusion F vaccine

For both studies, the primary exposure is maternal receipt of respiratory syncytial virus bivalent prefusion F vaccination during pregnancy in accordance with the Brazilian National Immunization Program recommendation (24⁺⁰/₇ to 36⁺⁶/₇ weeks' gestation) with the receipt of the vaccine 14 days or more before delivery.

Tarsila Inpatient Study Inclusion Criteria * 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. * Infant born at ≥37 weeks of gestational age. * Infant hospital admission for at least 24 hours with signs and symptoms meeting the case definition of ARI, defined as the presence of any of the following: nasal secretion for ≥24 hours; respiratory distress, labored breathing, or tachypnea (respiratory rate ≥60 breaths/min for infants \<2 months or ≥50 breaths/min for infants 2-12 months); cough; inability to feed for any period due to respiratory symptoms; apnea; or other relevant respiratory symptoms (examples include but are not limited to wheezing, crackles, and nasal flaring). Exclusion Criteria: * 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. * Absent or inconclusive RT-qPCR result for RSV. * Birth to a mother whose RSVpreF vaccination status could not be confirmed. Tarsila Outpatient Study Inclusion Criteria: * 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. * Infant born at ≥37 weeks of gestational age. * Infant presentation to an outpatient healthcare facility with signs and symptoms meeting the case definition of ARI, defined as the presence of any of the following: nasal secretion for ≥24 hours; respiratory distress, labored breathing, or tachypnea (respiratory rate ≥60 breaths/min for infants \<2 months or ≥50 breaths/min for infants 2-12 months); cough; inability to feed for any period due to respiratory symptoms; apnea; or other relevant respiratory symptoms (examples include but are not limited to wheezing, crackles, and nasal flaring). Exclusion Criteria: * Mother 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. * Lack of informed consent from the mother or the infant's legal guardian. * Absent or inconclusive RT-qPCR result for RSV. * Birth to a mother whose RSVpreF vaccination status could not be confirmed. * Enrollment in the study within the previous 30 days. If the interval exceeds 30 days, infants will be excluded if any previous episode tested positive for RSV.