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Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2026 to Jan 1, 2026
    • Study title expanded, about 7 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07279298
Lead Sponsor Bogotá District Health Secretariat
Conditions
(from sponsor)		 Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection, Bronchiolitis, Viral, Viral Respiratory Tract Infection
Related terms Bronchiolitis, Viral, Respiratory Syncytial Virus Infections
Enrollment 1,097 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov