A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

MedImmune, LLC1 个研究点目标入组 1,500 人开始时间: 待定最近更新: 2024年3月11日

试验速览

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•For the preterm cohort (excluding subjects with CLD, hemodynamically significant CHD, or Down syndrome): preterm infants in their first year of life and born < 35 weeks GA eligible to receive palivizumab in accordance with national or local guidelines or preterm infants who are 29 to 35 weeks GA and 6 to 12 months of age, including those with:
•(a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
•(b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
•For the CLD/CHD/Down syndrome cohort:
•(a) Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
•(b) Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD)
•Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (> 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
•(c) Subjects with Down syndrome - infants in their first year of life with a diagnosis of Down syndrome
•Infants who are entering their first RSV season at the time of screening

•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

safety

Safety and tolerability of MEDI8897 as assessed by the occurrence of all TEAEs, TESAEs, AESIs, and NOCDs

MEDI8897 and palivizumab serum concentrations
MEDI8897 and palivizumab PK parameters
Incidence of hospitalizations due to RT PCR-confirmed RSV(through 150 days after Dose 1 for Season 1 and Season 2)
Incidence of ADA to MEDI8897 and palivizumab in serum
Incidence of medically attended LRTI due to RT PCR-confirmed RSV(through 150 days after Dose 1 for Season 1 and Season 2)

发起方

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