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TARSILA Real-World Evidence Study

NCT07445763 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-03-03

No results posted yet for this study

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

Interventions

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⁺⁰/₇ to 36⁺⁶/₇ weeks' gestation) with the receipt of the vaccine 14 days or more before delivery.

Sponsors & Collaborators

  • Universidade Federal do Paraná

    collaborator OTHER

  • Inova Medical

    lead OTHER

Principal Investigators

  • Maicon Falavigna · Inova Medical

Eligibility

Min Age
0 Days
Max Age
360 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-09-30
Completion
2028-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07445763 on ClinicalTrials.gov