TARSILA Real-World Evidence Study

NCT07445763 | Not Yet Recruiting FDA Drug

• 1 other identifier: CAAE 95166426.7.1001.0008
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

respiratory syncytial virus; respiratory syncytial virus bivalent prefusion F vaccine; acute respiratory illness; lower respiratory tract disease; Maternal immunization; Tarsila study

Outcome Measures

Primary Outcomes (2)

• 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).

  Hospitalization occurring ≤180 days after birth

• 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).

  Occurring ≤180 days after birth.

Secondary Outcomes (4)

• 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

Other Outcomes (14)

• Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days by exploratory subgroups (Tarsila Inpatient Study)

  Hospitalization occurring ≤180 days after birth

• Lower respiratory Tract Disease (LRTD) ICU hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)

  Hospitalization occurring ≤180 days after birth. 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)

  Hospitalization occurring ≤180 days after birth

Study Arms (2)

Cases

Infants with a positive respiratory syncytial virus result on a nasal swab specimen

Biological: respiratory syncytial virus bivalent prefusion F vaccine

Controls

Infants with a negative respiratory syncytial virus result on a nasal swab specimen

Biological: respiratory syncytial virus bivalent prefusion F vaccine

Interventions

respiratory syncytial virus bivalent prefusion F vaccine BIOLOGICAL

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.

Cases; Controls

Eligibility Criteria

• Age: 0 Days - 360 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with acute respiratory illness (ARI)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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).
• 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.

Sponsors & Collaborators

• Inova Medical: lead
• Universidade Federal do Paraná: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swab specimens will be retained for reverse transcription-quantitative polymerase chain reaction testing for respiratory syncytial virus and other potential respiratory co-infecting pathogens.

Study Officials

• Maicon Falavigna

  Inova Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maicon Falavigna, MD PhD

CONTACT

+55 51 2399 1750; maicon@inovamedical.com.br

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 3, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02