Safety of RSV Preventive Monoclonal Antibody

Recruiting Phase 4 Interventional Study
Fever Adverse Event Following Immunisation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
6 Weeks – 30 Weeks
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
524 (estimated)
Sponsor
Duke University · Other
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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…
Trial Locations
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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 p…
Contacts

Michael J Smith, MD

919 684 6335

michael.j.smith@duke.edu

CONTACT

Emily A Randolph, MBA

919 385 5785

emily.randolph@duke.edu

CONTACT