Study Title
D5290C00004-A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)
Purpose
To determine if the study vaccine administered to healthy infants entering their first RSV season, in reducing lower respiratory tract infection due to confirmed RSV.
Eligibility
Healthy infants in their first year of life and born at least 35 weeks gestation
Infants entering their first RSV season at the time of screening
Available to complete the follow-up period, which will be 17 months after receipt of study drug
You Cannot
Any fever ≥ 100.4°F or acute illness within 7 days prior to injectio
Any history of LRTI or active LRTI
Known history of RSV infection or active RSV infection
Any drug therapy (chronic or other) within 7 days prior to injection or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) that may be permitted according to the judgment of the investigator
Any current or expected receipt of immunosuppressive agents including steroids (exceptfor the use of topical steroids according to the judgment of the investigator)
Closed to Enrollment
Study Process
Single dose
Most visits conducted during well baby visits
Interested in more information on clinical research? Contact WK Health System Clinical Research Department 318-212-8130
Trial Details
Investigator:
IRB:
CGIRB
IRB Number:
Trial Type:
Drug
Sponsor:
Astra Zenca
Contact Information: