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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 主要终点
- Lower respiratory Tract Disease (LRTD) Hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)
研究概览
简要总结
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.
详细描述
Tarsila comprises two multicenter, prospective, case-control studies using a test-negative design in Southern Brazil (states of Rio Grande do Sul, Santa Catarina, and Paraná). The Tarsila Inpatient study will enroll infants hospitalized due to acute respiratory illness and will be conducted at referral hospitals. The Tarsila Outpatient study will enroll infants with acute respiratory illness managed in outpatient settings and will be conducted at outpatient healthcare facilities. Both studies are aligned with the nationwide introduction of maternal RSVpreF vaccination in December 2025, with enrollment occurring from April, 2026 to September, 2028. In both studies, the same clinical case definition will be applied to cases and controls. Reverse transcription quantitative polymerase chain reaction (RT-qPCR) for RSV will be prospectively performed to classify case infants (RT-qPCR positive for RSV) and control infants (RT-qPCR negative for RSV). Maternal RSVpreF vaccination status and potential confounders will be assessed through structured interviews and review of medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 360 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Cases
Infants with a positive respiratory syncytial virus result on a nasal swab specimen
干预措施: respiratory syncytial virus bivalent prefusion F vaccine (Biological)
Controls
Infants with a negative respiratory syncytial virus result on a nasal swab specimen
干预措施: respiratory syncytial virus bivalent prefusion F vaccine (Biological)
结局指标
主要结局
Lower respiratory Tract Disease (LRTD) Hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)
时间窗: Hospitalization occurring ≤180 days after birth
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)
时间窗: Occurring ≤180 days after birth.
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).
次要结局
- Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days by subgroups (Tarsila Inpatient Study)(Hospitalization occurring ≤180 days after birth)
- Severe Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)(Hospitalization occurring ≤180 days after birth)
- Severe Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days by subgroups (Tarsila Inpatient Study)(Hospitalization occurring ≤180 days after birth)
- Acute respiratory illness (ARI) among infants aged up to 180 days by Subgroups (Tarsila Outpatient Study)(ARI occurring ≤180 days after birth)
研究者
Maicon Falavigna
Research director
Inova Medical