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RecruitingPhase 4NCT07158814

Safety of RSV Preventive Monoclonal Antibody

◆ AI Clinical Summary
Plain-language summary for patients

Trial Parameters

ConditionFever
SponsorDuke University
Study TypeINTERVENTIONAL
PhasePhase 4
Enrollment524
SexALL
Min Age6 Weeks
Max Age30 Weeks
Start Date2025-10-02
Completion2027-02
Interventions
Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody

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Brief 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).

Eligibility Criteria

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: * Know

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