A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b)

MedImmune

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Placebo; Drug: MEDI8897

Study type: Interventional

Funder types: Industry

Identifiers

NCT02878330

D5290C00003

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 preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.

Full description

This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Participants will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the Southern Hemisphere.

Enrollment: 1,453 patients

Sex: All

Ages: Under 365 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
2. Infants who are entering their first full RSV season at the time of screening.

Key Exclusion Criteria:

1. Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.
2. Any fever (>= 100.4°F [>= 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization.
3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization.
4. Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection.
5. 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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1,453 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.

Treatment:

Drug: Placebo

MEDI8897 50 mg

Experimental group

Description:

Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.

Treatment:

Drug: MEDI8897