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.
Infants with acute respiratory illness (ARI)
Case-control
Prospective
respiratory syncytial virus bivalent prefusion F vaccine
Biological/VaccineFor 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.
Lower respiratory Tract Disease (LRTD) Hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)
Hospitalization due to RT-qPCR-confirmed RSV-positive lower respiratory tract disease, defined as cough or difficulty breathing, symptom onset within the preceding 10 days, and at least one of the following: tachypnea (respiratory rate ≥60 breaths/min for infants \<2 months; ≥50 breaths/min for infants 2-12 months), oxygen saturation (SpO₂) \<95%, or chest wall indrawing).
Acute respiratory illness (ARI) among infants aged up to 180 days (Tarsila Outpatient Study)
RT-qPCR-confirmed RSV-positive 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).
Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days by subgroups (Tarsila Inpatient Study)
RT-qPCR-confirmed RSV-positive LRTD hospitalization, analyzed by: * Gestational age at RSVpreF vaccination. * Time from RSVpreF vaccination to birth. * Time intervals of infant age at illness.
Severe Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)
RT-qPCR-confirmed RSV-positive severe LRTD hospitalization, defined as LRTD plus at least one of the following: respiratory rate ≥70 breaths/min (if \<2 months) or ≥60 breaths/min (if ≥2 months); SpO₂ \<93%; requirement for high-flow oxygen, non-invasive, or invasive mechanical ventilation; intensive care unit (ICU) admission for \>4 hours; or unresponsiveness/loss of consciousness) .
Severe Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days by subgroups (Tarsila Inpatient Study)
RT-qPCR-confirmed RSV-positive severe LRTD hospitalization, analyzed by: * Gestational age at RSVpreF vaccination. * Time from RSVpreF vaccination to birth. * Time intervals of infant age at illness.
Acute respiratory illness (ARI) among infants aged up to 180 days by Subgroups (Tarsila Outpatient Study)
RT-qPCR-confirmed RSV-positive ARI analyzed by: gestational age at RSVpreF vaccination, time from RSVpreF vaccination to birth, and time intervals of infant age at illness.
Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days by exploratory subgroups (Tarsila Inpatient Study)
RT-qPCR-confirmed RSV-positive LRTD hospitalization, analyzed by: * RSV subtype (RSV-A, RSV-B). * Human milk feeding status (e.g., breastfeeding). * RSVpreF administration with other vaccines received during pregnancy. * RSVpreF vaccination status in a previous pregnancy.
Lower respiratory Tract Disease (LRTD) ICU hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)
RT-qPCR-confirmed RSV-positive LRTD ICU hospitalization. ICU admission occuring at any point during the index hospitalization.
Lower respiratory Tract Disease (LRTD) prolonged hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)
RT-qPCR-confirmed RSV-positive LRTD long hospital stay (≥11 days) .
Lower respiratory Tract Disease (LRTD) in-hospital death among infants aged up to 180 days (Tarsila Inpatient Study)
RT-qPCR-confirmed RSV-positive LRTD in-hospital death.
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Inova Medical
Lead sponsor
Universidade Federal do Paraná
Collaborator
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