Safety of RSV Preventive Monoclonal Antibody
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-30
SponsorDuke University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Known contraindication or precaution to RSV monoclonal antibody or other routine vaccines being administered
Received any vaccine within 14 days prior to enrollment and the first immunization day in this study
Known previous receipt of RSV monoclonal antibody
Received any experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to immunization in this study or expects to receive an experimental/investigational agent within the follow-up time period (8 days after the second immunization in this study)
Trial design
Design model
Parallel
Treatments tested in this trial
Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
DrugACIP Recommended Preventive Monoclonal Antibody
Treatment groups
524 Participants
are divided into 2 treatment groupsGroup A: Simultaneous ImmunizationExperimental treatment 1 intervention
Group B: Sequential ImmunizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 administrationSecondary outcomes
1
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 administration2
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 administration3
The Number of Participants with At Least One Serious Adverse Event
Time frame
Up to 98 days post administration4
The Number of Participants with At Least One Adverse Event of Special Interest
Time frame
Up to 98 days post administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Columbia University
Collaborator
Emory University
Collaborator
Kaiser Permanente
Collaborator
Source ClinicalTrials.gov