Safety and Efficacy of MEDI8897 against RSV (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 Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

Protocol Description

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection among infants and children. Prevention of RSV illnesses in all infants is a public health priority but, despite almost 50 years of attempted vaccine development and extensive ongoing work, there is not yet a safe and effective vaccine. While RSV prevention exists in the form of a specific RSV IgG (Synagis®, palivizumab) requiring 5 monthly injections, it is licensed only for infants that are high-risk because of prematurity or other medical problems. Currently, there is no approved RSV prophylaxis for healthy infants, and there is no treatment for active RSV infection. MEDI8897 is being developed to protect all infants from RSV disease.


Children enrolled in the study will have careful monitoring and follow-up for lower respiratory tract infections for 17 months from the time of study enrollment. There will be no charge for study related visits. The study team is available by phone, 24 hours a day.

Study Level: Phase 3

Eligibility Criteria

Subject to certain exclusion criteria. Healthy late preterm and term infants, who are entering their first RSV season, are eligible to enroll in the study.


  • Receive 1 dose of MEDI8897 (study drug) or placebo (no active study drug). Your child would have a 2 out of 3 chance of receiving MEDI8897. Either is given by injection.
  • Five additional study visits over the course of 1 year; 3 blood draws.
  • Study team will examine infants with cold symptoms within 48 hours of any symptom suggestive of a lower respiratory tract infection and obtain a nasal swab to test for RSV.

Status: Open to Enrollment

Source(s) of Support

MedImmune, LLC

Primary Investigator

Judith Martin, MD

Contact Information

For additional information or to enroll, please contact 412-692-7382.