Actively Recruiting
Safety of RSV Preventive Monoclonal Antibody
Led by Duke University · Updated on 2026-03-16
524
Participants Needed
6
Research Sites
78 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
C
Centers for Disease Control and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety of RSV Preventive Monoclonal Antibody
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants 6 weeks to less than 30 weeks of age at enrollment
- Eligible for RSV monoclonal antibody and at least one routine childhood vaccine in outpatient clinic
- Parent or legal guardian willing and capable of giving written informed consent
- Parent or legal guardian can read and understand English or Spanish
- Parent or legal guardian available for follow-up contact by telephone through study completion
- Parent or legal guardian agrees to sign medical record release for infant if needed
- Parent or legal guardian willing to delay RSV monoclonal antibody up to two weeks and return for second visit if needed
You will not qualify if you...
- Known contraindication or precaution for RSV monoclonal antibody or routine vaccines administered
- Received any vaccine within 14 days prior to enrollment or first immunization day
- Previous receipt of RSV monoclonal antibody
- Received or plans to receive experimental or investigational agents within 28 days prior or 8 days after second immunization
- Moderate to severe acute illness or fever (≥100.4°F/38.0°C) within 48 hours before enrollment
- Use of antipyretic medication within 48 hours prior to enrollment
- Planned prophylactic use of antipyretics on immunization day and following days (except as needed for fever or pain)
- Conditions posing unacceptable risk or inability to meet protocol requirements per investigator
- First-degree relative of study personnel
- Infant born to mother vaccinated for RSV more than 14 days before delivery and not eligible for RSV antibody
- Bleeding disorder or risk of prolonged bleeding
- History of severe adverse reaction or allergy to vaccines or RSV antibody components
- Active cancer or history of blood cancers
- Severe allergic reaction after previous vaccine dose or vaccine components
- Immunosuppression due to illness or treatment, including anti-cancer therapies since birth
- For infants receiving DTaP: encephalopathy within 7 days after previous DTaP dose
- Plans to receive other vaccines within 4 weeks after Visit 1 unless medically necessary
- Long-term use of high-dose steroids within 6 months prior to enrollment (topical, nasal, inhaled steroids allowed)
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Kaiser Permanente Northern California
Oakland, California, United States, 94612
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
Active, Not Recruiting
4
Columbia University
New York, New York, United States, 10027
Actively Recruiting
5
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
M
Michael J Smith, MD
CONTACT
E
Emily A Randolph, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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