Respiratory Syncytial Virus (RSV)TARSILANCT07445763
TARSILA Real-World Evidence Study
An observational study of Respiratory Syncytial Virus (RSV) and Maternal Immunization, run by Inova Medical.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 360 days
- Conditions the study is for
- Respiratory Syncytial Virus (RSV), Maternal Immunization, Acute Respiratory Illness (ARI)
- What is being tested?
- respiratory syncytial virus bivalent prefusion F vaccine
- Type of treatment
- Vaccines
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 360 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants with acute respiratory illness (ARI)
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
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- Tarsila Outpatient Study
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Respiratory Syncytial Virus (RSV), Maternal Immunization, Acute Respiratory Illness (ARI), Lower Respiratory Tract Disease, Infant Outcomes
- Being tested
- respiratory syncytial virus bivalent prefusion F vaccine
- Keywords
- respiratory syncytial virus, respiratory syncytial virus bivalent prefusion F vaccine, acute respiratory illness, lower respiratory tract disease, Maternal immunization, Tarsila study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory syncytial virus bivalent prefusion F vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Infants with a positive respiratory syncytial virus result on a nasal swab specimen Receives: Biological: respiratory syncytial virus bivalent prefusion F vaccine | |
| Controls | Infants with a negative respiratory syncytial virus result on a nasal swab specimen Receives: Biological: respiratory syncytial virus bivalent prefusion F vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
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.
Measured: Hospitalization occurring ≤180 days after birth
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) .
Measured: 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)
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.
Measured: Hospitalization occurring ≤180 days after birth
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.
Measured: ARI occurring ≤180 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Paraná
- Responsible party
- Principal investigator, Maicon Falavigna, Inova Medical
- Investigators
- Maicon Falavigna, Principal investigator, Inova Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445763
- Sponsor's protocol ID
- CAAE 95166426.7.1001.0008
- Acronym
- TARSILA
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07445763
- Acronym / sponsor ID
- TARSILA / CAAE 95166426.7.1001.0008
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Inova MedicalUniversity, hospital or other
- Collaborators
- Universidade Federal do Paraná
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Biological: respiratory syncytial virus bivalent prefusion F vaccineInfants with a positive respiratory syncytial virus result on a nasal swab specimen |
| Controls | – | Biological: respiratory syncytial virus bivalent prefusion F vaccineInfants with a negative respiratory syncytial virus result on a nasal swab specimen |
Who may qualify
- Ages
- 0 to 360 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with acute respiratory illness (ARI)
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| respiratory syncytial virus bivalent prefusion F 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. | Biological | Cases, Controls |
Primary outcome
Lower respiratory Tract Disease (LRTD) Hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)
Time frame: 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)
Time frame: 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).
4 secondary outcomes
Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days by subgroups (Tarsila Inpatient Study)
Time frame: Hospitalization occurring ≤180 days after birth
Severe Lower respiratory Tract Disease (LRTD) hospitalization among infants aged up to 180 days (Tarsila Inpatient Study)
Time frame: 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)
Time frame: Hospitalization occurring ≤180 days after birth
Acute respiratory illness (ARI) among infants aged up to 180 days by Subgroups (Tarsila Outpatient Study)
Time frame: ARI occurring ≤180 days after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maicon Falavigna principal investigator
Inova Medical
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus (RSV) and Maternal Immunization, run by Inova Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maicon Falavigna, MD PhD (+55 51 2399 1750, maicon@inovamedical.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower respiratory Tract Disease (LRTD) Hospitalization among infants aged up to 180 days (Tarsila Inpatient Study) (time frame: Hospitalization occurring ≤180 days after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.