Melody Study

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 RespiratorySyncytial Virus, in Healthy Late Preterm and Term Infants(MELODY)

In follow up – will open to recruitment again in September 2021.

To assess the efficacy of MEDI8897 when administered as a single fixed IM dose to infants ≥ 35 weeks 0 days gestational age and entering their first RSV season, in reducing medically attended lower resiptory tract infection due to RT-PCR-confirmed RSV, compared to placebo.

Inclusion criteria: Healthy infants in their first year of life and born ≥ 35 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible). Infants who are entering their first RSV season at the time of screening

Exclusion criteria:

  1. Meets national or other local criteria to receive commercial palivizumab
  2. Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
  3. Any history of LRTI or active LRTI prior to, or at the time of, randomization
  4. Known history of RSV infection or active RSV infection prior to, or at the time of randomization
  5. Any drug therapy (chronic or other) within 7 days prior to randomization 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
  6. Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the investigator)
  7. History of receipt of blood, blood products, or immunoglobulin products, or expected receipt through the duration of the study
  8. Receipt of any investigational drug
  9. Known renal impairment
  10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
  11. History of CLD/bronchopulmonary dysplasia
  12. Clinically significant congenital anomaly of the respiratory tract
  13. Chronic seizure or evolving or unstable neurologic disorder
  14. CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect)
  15. Prior history of a suspected or actual acute life-threatening event
  16. Known immunodeficiency, including human immunodeficiency virus (HIV)
  17. Mother with HIV infection (unless the child has been proven to be not infected)
  18. Any known allergy, including to immunoglobulin products, or history of allergic reaction
  19. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
  20. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV immunoglobulin)
  21. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
  22. Concurrent enrollment in another interventional study
  23. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

What participating in the study involves? Subjects will be vaccinated with either MEDI8897 or placebo. They will be monitored throughout the study for lower respiratory tract infection.

Parent Brochure
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