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

NCT02878330 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1453

Last updated 2019-10-14

Study results available
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Summary

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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

MEDI8897

A single IM dose of 50 mg on Day 1 of the study.

DRUG

Placebo

A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
365 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2018-07-17
Completion
2018-12-06

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Estonia
  • Finland
  • France
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • New Zealand
  • Poland
  • South Africa
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02878330 on ClinicalTrials.gov