CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,453 enrolled
Drug / intervention
MEDI8897 +1 moredrug
Likely dose
MEDI8897 50 mg single intramuscular dose on Day 1AI-extracted
Key inclusion· 2
  • ✓Healthy infants born at 29 weeks 0 days to 34 weeks 6 days gestational age
  • ✓Entering their first full RSV season at screening
Key exclusion· 5
  • ✕Meets AAP or local criteria to receive commercial palivizumab
  • ✕Fever (≥100.4°F/≥38.0°C) or lower respiratory illness within 7 days prior to randomization
  • ✕Acute illness with moderate or severe signs/symptoms at randomization
  • ✕Active RSV infection or documented prior RSV infection (negative RSV testing required if respiratory symptoms present)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02878330
NCT02878330Phase 2Completed
CompareCT.gov

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

MedImmune LLC·interventional·Posted Aug 25, 2016·Updated Oct 14, 2019

In Brief

A Phase 2 clinical trial evaluating MEDI8897 and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 1,453 participants across 161 sites in 23 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 25, 2016
Enrollment StartNov 3, 2016
Primary CompletionJul 17, 2018
Study CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.9 years ago

Interventions

MEDI8897drug

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

Placebodrug

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