[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-outcomes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-outcomes":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100627217",false,"NCT07445763","TARSILA Real-World Evidence Study","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","TARSILA","Tarsila Inpatient Study\n\nInclusion Criteria\n\n* Infant born in Brazil.\n* Mother resident in Brazil during the related pregnancy.\n* 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.\n* Infant ≤360 days of age at time of RSV specimen collection.\n* Infant born at ≥37 weeks of gestational age.\n* 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\u002Fmin for infants \\\u003C2 months or ≥50 breaths\u002Fmin 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).\n\nExclusion Criteria:\n\n* Maternal or infant receipt of any other licensed or investigational RSV preventive product.\n* Infant receipt of blood transfusion or other blood products containing antibodies since birth.\n* Infant previously enrolled in this study.\n* Lack of informed consent from the mother or the infant's legal guardian.\n* Absent or inconclusive RT-qPCR result for RSV.\n* Birth to a mother whose RSVpreF vaccination status could not be confirmed.\n\nTarsila Outpatient Study\n\nInclusion Criteria:\n\n* Infant born in Brazil.\n* Mother resident in Brazil during the related pregnancy.\n* 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.\n* Infant ≤360 days of age at time of RSV specimen collection.\n* Infant born at ≥37 weeks of gestational age.\n* 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\u002Fmin for infants \\\u003C2 months or ≥50 breaths\u002Fmin 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).\n\nExclusion Criteria:\n\n* Mother or infant receipt of any other licensed or investigational RSV preventive product.\n* Infant receipt of blood transfusion or other blood products containing antibodies since birth.\n* Lack of informed consent from the mother or the infant's legal guardian.\n* Absent or inconclusive RT-qPCR result for RSV.\n* Birth to a mother whose RSVpreF vaccination status could not be confirmed.\n* 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.","ALL","0 Days","360 Days",{"count":20,"type":21},5000,"ESTIMATED","OBSERVATIONAL","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.",[25,26,27,28,29],"Respiratory Syncytial Virus (RSV)","Maternal Immunization","Acute Respiratory Illness (ARI)","Lower Respiratory Tract Disease","Infant Outcomes",[31,32,33,34,35,36],"respiratory syncytial virus","respiratory syncytial virus bivalent prefusion F vaccine","acute respiratory illness","lower respiratory tract disease","Maternal immunization","Tarsila study","NOT_YET_RECRUITING","2026-02-25",{"date":40,"type":41},"2026-03-03","ACTUAL",{"date":43,"type":21},"2026-04-30",{"date":45,"type":21},"2028-12-31",{"name":47,"class":48},"Inova Medical","OTHER",""]