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A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

NCT03959488 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 925

Last updated 2023-09-21

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

MEDI8897

Anti-RSV monoclonal antibody with an extended half-life

DRUG

Palivizumab

Approved anti-RSV monoclonal antibody

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2021-05-03
Completion
2023-01-20
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • New Zealand
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT03959488 on ClinicalTrials.gov