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Safety of RSV Preventive Monoclonal Antibody

StatusRecruiting
PhasePhase 4
Started2025-10-02
View on ClinicalTrials.gov ↗

Amendment history

2026-03-12
Study Status v5
Primary completion date2026-02-12→2027-02
Completion date2026-04→2027-04
2026-02-18
Study Status, Contacts/Locations v4
Primary completion dateestimated 2026-01→confirmed 2026-02-12
Study sitescontacts updated at 2 of 6 sites
2025-12-10
Study Status, Contacts/Locations v3
Study sitesdetails revised at 3 of 6 sites
2025-10-27
Study Status, Contacts/Locations v2
Study sitesdetails revised at 2 of 6 sites
2025-10-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-10-02
Study sitesdetails revised at 6 of 6 sites
2025-09-04
Original filing
Duke University
455 trials monitored
See 53 trials at risk
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).
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