[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627217":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":10,"responsibleParty":34,"collaborators":36,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":10},{"fullName":5,"class":6},"Inova Medical","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cases",null,"Infants with a positive respiratory syncytial virus result on a nasal swab specimen",[13],"Biological: respiratory syncytial virus bivalent prefusion F vaccine",{"label":15,"type":10,"description":16,"interventionNames":17},"Controls","Infants with a negative respiratory syncytial virus result on a nasal swab specimen",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"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\u002F₇ to 36⁺⁶\u002F₇ weeks' gestation) with the receipt of the vaccine 14 days or more before delivery.",[9,15],[25],{"name":26,"affiliation":5,"role":27},"Maicon Falavigna","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Maicon Falavigna, MD PhD","CONTACT","+55 51 2399 1750","maicon@inovamedical.com.br",{"type":27,"investigatorFullName":26,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Research director",[37],{"name":38,"class":6},"Universidade Federal do Paraná","100627217","tarsila-real-world-evidence-study-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":51,"type":52},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.",[56,57,58,59,60],"Respiratory Syncytial Virus (RSV)","Maternal Immunization","Acute Respiratory Illness (ARI)","Lower Respiratory Tract Disease","Infant Outcomes",[62,21,63,64,65,66],"respiratory syncytial virus","acute respiratory illness","lower respiratory tract disease","Maternal immunization","Tarsila study","NOT_YET_RECRUITING","2026-02-25",{"date":70,"type":71},"2026-03-03","ACTUAL",{"date":73,"type":52},"2026-04-30",{"date":75,"type":52},"2028-12-31",{"name":5,"class":6}]