RecruitingPhase 4NCT07158814

Safety of RSV Preventive Monoclonal Antibody

Safety of Simultaneous Administration of Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody With Routine Childhood Immunizations in Infants

Sponsor

Duke University

Enrollment

524 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

Fever Adverse Event Following Immunisation

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).

Eligibility

Min Age: 6 WeeksMax Age: 30 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody for people with adverse event following immunisation and fever. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 6 Weeks to 30 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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