Safety of Simultaneous Administration of Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody With Routine Childhood Immunizations in Infants
Duke University
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).
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.
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Infants ≥ 6 weeks to \<30 weeks of age at the time of enrollment * Infants eligible for RSV monoclonal antibody and at least one routine childhood vaccine in outpatient clinic * The parent/legal guardian must be willing and capable of providing permission for their infant to participate through the written informed consent process * Parent/legal guardian must be able to read and comprehend English or Spanish * The parent/legal guardian must be available for follow-up study contact by telephone from enrollment to completion of the study period * The parent/legal guardian…
Interventions
- DrugRespiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
ACIP Recommended Preventive Monoclonal Antibody
Locations (6)
- Kaiser Permanente Northern CaliforniaOakland, California
- Emory UniversityAtlanta, Georgia
- Centers for Disease Control and PreventionAtlanta, Georgia
- Columbia UniversityNew York, New York
- Duke UniversityDurham, North Carolina
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio