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).
Who can participate
Age range6 Weeks – 30 Weeks
SexALL
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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 must agree to sign a medical record release for the infant so that study personnel may obtain medical information about the infant's health (if needed)
* The parent/legal guardian must be willing to delay their child's receipt of RSV monoclonal antibody up to two weeks from the scheduled date and to return for a second visit to receive the deferred RSV monoclonal antibody
Exclusion Criteria:
* 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 f…
What they're measuring
1
Number of Participants with Fever Following Immunization