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A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

NCT03979313

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Respiratory Syncytial Virus Infections

Interventions: MEDI8897, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

Eligibility overview

Sex: ALL

Age: 0 Years to 1 Year

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Healthy infants in their first year of life and born at or after 35 weeks 0 days GA
* Infants who are entering their first RSV season at the time of screening

Key Exclusion Criteria:

* Meets national or other local criteria to receive commercial palivizumab
* Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to randomization
* Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
* Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination
Locations (198)
  • Birmingham, Alabama, United States
  • Fort Defiance, Arizona, United States
  • Fayetteville, Arkansas, United States
  • Anaheim, California, United States
  • Downey, California, United States
  • National City, California, United States
  • Paramount, California, United States
  • West Covina, California, United States
  • Aurora, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Gainesville, Florida, United States
  • Hialeah, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Fort Gordon, Georgia, United States
  • Chicago, Illinois, United States
  • Oak Lawn, Illinois, United States
  • Indianapolis, Indiana, United States
  • West Des Moines, Iowa, United States
  • Bardstown, Kentucky, United States
  • Lexington, Kentucky, United States
  • Shreveport, Louisiana, United States
  • Jackson, Mississippi, United States
  • Columbia, Missouri, United States
  • Lincoln, Nebraska, United States
  • Omaha, Nebraska, United States
  • Gallup, New Mexico, United States
  • Shiprock, New Mexico, United States
  • Syracuse, New York, United States
  • + 168 more on CT.gov