Clinical Trial

Safety of RSV Preventive Monoclonal Antibody

Recruiting Phase 4
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Summary
This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other vaccines at separate visits (Visits 1 and 2).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-09-04; most recent amendment 2026-03-12.
Status change: Not Yet Recruiting → Recruiting 2025-10-13
Trial Details
NCT Number NCT07158814
Lead Sponsor Duke University
Collaborators: Centers for Disease Control and Prevention, Children's Hospital Medical Center, Cincinnati, Columbia University, Emory University, Kaiser Permanente
Conditions Fever, Adverse Event Following Immunisation
Enrollment 524 participants
Start Date 2025-10-02
Primary Completion 2027-02 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-16