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)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: MEDI8897; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03979313

2019-000114-11 (EudraCT Number)

D5290C00004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,012 patients

Sex: All

Ages: Under 1 year old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,012 participants in 2 patient groups, including a placebo group

MEDI8897

Experimental group

Description:

Anti-RSV monoclonal antibody with an extended half-life

Treatment:

Drug: MEDI8897

Placebo

Placebo Comparator group

Description:

Commercially available 0.9% (w/v) saline

Treatment:

Drug: Placebo