NCT07158814

Safety of RSV Preventive Monoclonal Antibody

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 6 Weeks – 30 Weeks
• Healthy volunteers: Accepted

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).

Detailed description

Parent(s) or legal guardians will assess fever and other solicited local and systemic adverse events on the day of immunization (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period.

Conditions

• Fever
• Adverse Event Following Immunisation

Interventions

Type	Name	Description
DRUG	Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody	ACIP Recommended Preventive Monoclonal Antibody

Timeline

• Start date: 2025-10-02
• Primary completion: 2027-02-01
• Completion: 2027-04-01
• First posted: 2025-09-08
• Last updated: 2026-03-16

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study