๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-12

Safety of RSV Preventive Monoclonal Antibody (NCT07158814)

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

๐ŸŸข Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Duke University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Kaiser Permanente Northern California โ€” Oakland, California

Age range: 6 Weeks to 30 Weeks

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (6 Sites)

  • Kaiser Permanente Northern California โ€” Oakland, California
  • Emory University โ€” Atlanta, Georgia
  • Centers for Disease Control and Prevention โ€” Atlanta, Georgia
  • Columbia University โ€” New York, New York
  • Duke University โ€” Durham, North Carolina
  • Cincinnati Children's Hospital Medical Center โ€” Cincinnati, Ohio

๐Ÿ“ž Contact the Study Coordinator

Phone: (919) 684-6335

Email: michael.j.smith@duke.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Fever clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—