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.

Criteria

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) 

Details

Single dose         

Most visits conducted during well baby visits



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IRB: CGIRB
IRB Number:
Trial Type: Drug
Sponsor: Astra Zenca