Safety of RSV Preventive Monoclonal Antibody

Part of paid clinical trials in Oakland, California.

Sponsor
Duke University
Study ID
NCT07158814
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Adverse Event Following Immunisation
  • Fever

Eligibility Criteria

Sex
ALL
Age
6 Weeks - 30 Weeks
Healthy Volunteers
Accepted

Interventions

  • Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody — DRUG
    ACIP Recommended Preventive Monoclonal Antibody

Study Details

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).

Key Dates

Start date
Oct 2, 2025
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
524 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Simultaneous Immunization
    The simultaneous immunization group will receive routine childhood vaccinations and respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 1.
  • Experimental: Sequential Immunization
    The sequential immunization group will receive routine childhood vaccinations at Visit 1, followed by respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 2.

Primary Outcome Measure

Number of Participants with Fever Following Immunization [ Time Frame: Up to 2 days post administration ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Northern CaliforniaOaklandCalifornia94612
Nicola Klein, MD
[email protected]
510-267-7540
Centers for Disease Control and PreventionAtlantaGeorgia30333-
Emory UniversityAtlantaGeorgia30322
Satoshi Kamidani
[email protected]
Columbia UniversityNew YorkNew York10027
Melissa S Stockwell, MD
[email protected]
212-342-5732
Duke UniversityDurhamNorth Carolina27710
Michael J Smith, MD
[email protected]
919-684-6335
Emily A Randolph, MBA
[email protected]
919-385-5785
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Elizabeth Schlaudecker, MD
[email protected]
513-803-0747
Mary Staat, MD
[email protected]
513-636-2877

Find similar trials in Oakland, CA

By research site
Kaiser Permanente Northern California· Oakland, CACenters for Disease Control and Prevention· Atlanta, GAEmory University· Atlanta, GAColumbia University· New York, NYDuke University· Durham, NCCincinnati Children's Hospital Medical Center· Cincinnati, OH

Related Studies