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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)

NCT03979313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3012

Last updated 2024-02-28

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 late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

MEDI8897

Anti-RSV monoclonal antibody with an extended half-life

DRUG

Placebo

Commercially available 0.9% (w/v) saline

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
Yes

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2021-03-11
Completion
2023-03-21
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
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 NCT03979313 on ClinicalTrials.gov