MedTrace Logo

Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV

NCT07279298 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1097

Last updated 2025-12-12

No results posted yet for this study

Summary

This study aims to evaluate the real-world effectiveness of two preventive immunization strategies against Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection in infants less than six months of age in Bogotá, Colombia. The strategies include maternal vaccination with RSVpreF administered between 28 and 36 weeks of gestation and neonatal immunization with nirsevimab for infants born to mothers who did not receive RSVpreF during pregnancy. Using a test-negative case-control design embedded in the city's sentinel surveillance system, infants hospitalized for severe respiratory infection will be systematically tested for RSV. Comparative vaccine effectiveness will be estimated to determine the impact of maternal RSV vaccination and neonatal monoclonal antibody immunization on RSV-associated hospitalizations, intensive care admissions, and mortality. The study will generate real-world evidence to inform local and regional public health decisions and guide the implementation of cost-effective hybrid immunization strategies against RSV in middle-income settings.

Conditions

  • Respiratory Syncytial Virus Infections
  • Severe Acute Respiratory Infection
  • Bronchiolitis, Viral
  • Viral Respiratory Tract Infection

Interventions

BIOLOGICAL

RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed

Maternal vaccination administered between 28 and 36 weeks of gestation and Single-dose monoclonal antibody administered to newborns whose mothers did not receive effective RSVpreF vaccination or unexposed

Sponsors & Collaborators

  • Bogotá District Health Secretariat

    lead OTHER_GOV

Principal Investigators

  • Julián Alfredo Fernández Niño · Bogotá District Health Secretariat

Eligibility

Min Age
1 Day
Max Age
180 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-12-31
Completion
2027-07-31

More Related Trials

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 NCT07279298 on ClinicalTrials.gov