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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
524
ACIP Recommended Preventive Monoclonal Antibody
Kaiser Permanente Northern California
Oakland, California, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGCenters for Disease Control and Prevention
Atlanta, Georgia, United States
Number of Participants with Fever Following Immunization
Number of infants with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
Time frame: Up to 2 days post administration
Number of Participants with Grade 2 and/or 3 Fever Following Visit 1
Number of infants with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Time frame: Up to 2 days post administration
Number of Participants with Grade 2 and/or 3 Fever Following Visit 2
Number of infants with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Time frame: Up to 2 days post administration
The Number of Participants with At Least One Serious Adverse Event
Time frame: Up to 98 days post administration
The Number of Participants with At Least One Adverse Event of Special Interest
Time frame: Up to 98 days post administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Columbia University
New York, New York, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITING