A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants

  • STATUS
    Recruiting
  • End date
    Mar 29, 2023
  • participants needed
    3000
  • sponsor
    MedImmune LLC
Updated on 26 September 2021

Summary

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.

Description

This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their first RSV season. The population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing. Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and Southern Hemisphere.

Details
Condition Respiratory syncytial virus infection, rsv infection
Treatment Placebo, MEDI8897
Clinical Study IdentifierNCT03979313
SponsorMedImmune LLC
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Meets national or other local criteria to receive commercial palivizumab
Any fever ( 100.4F [ 38.0C], 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
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