A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-13

Study Completion Date

2016-09-28

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.

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Detailed Description

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This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children. The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines. These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy. Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.

Conditions

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Respiratory Syncytial Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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Placebo

Participants will receive placebo intramuscularly.

Intervention Type DRUG

MEDI8897 10 mg

Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.

Intervention Type DRUG

MEDI8897 25 mg

Participants will receive a single dose of MEDI8897 25 mg intramuscularly.

Intervention Type DRUG

MEDI8897 50 mg

Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
* Infants who are entering their first RSV season at the time of screening

Exclusion Criteria

* Gestational age \< 32 weeks 0 days and \>34 weeks 6 days
* Meets AAP or other local criteria to receive commercial palivizumab
* Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization
* Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of 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 any RSV vaccine, including maternal RSV vaccination

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes