A Phase 3 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 Late Preterm and Term Infants (MELODY)

MedImmune, LLC1 个研究点目标入组 3,000 人开始时间: 待定最近更新: 2024年3月11日

试验速览

阶段: 3 期
状态: 已完成
发起方: MedImmune, LLC
入组人数: 3,000
试验地点: 1
主要终点: Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV

暂无简介。

•Healthy infants in their first year of life and born > 36 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis with no other risk factors are eligible)
•Infants who are entering their first RSV season at the time of screening

•Meets national or other local criteria to receive commercial palivizumab
•Any fever (>38.0 degree celsius), regardless of route) or acute illness within 7 days prior to randomization
•Any history of LRTI or active LRTI prior to, or at the time of, randomization
•Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
•Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination

Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV

时间窗: 150 days after dosing (ie, during a typical 5-month RSV season)

Incidence of medically attended lower respiratory tract infection (LRTI) (inpatient and outpatient) due to RT-PCR-confirmed RSV

Incidence of hospitalizations due to RT-PCR-confirmed RSV through 150 days after dosing(150 days after dosing)
Safety and tolerability of MEDI8897
Summary of MEDI8897 serum concentrations and estimated PK parameters
Incidence of ADA to MEDI8897 in serum

发起方

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