MEDLEY study
- Conditions
- Respiratory Syncytial Virus Infections
- Registration Number
- JPRN-jRCT2080224799
- Lead Sponsor
- MedImmune, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 1500
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety and tolerability of MEDI8897 as assessed by the occurrence of all TEAEs, TESAEs, AESIs, and NOCDs
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>- MEDI8897 and palivizumab serum concentrations<br>- MEDI8897 and palivizumab PK parameters: Summary of serum concentrations and estimated PK parameters (Cmax, AUC, apparent clearance, and t1/2, if data permit)<br>other<br>Incidence of ADA to MEDI8897 and palivizumab in serum<br>efficacy<br>- Incidence of medically attended LRTI (inpatient and outpatient) due to RT PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2<br>- Incidence of hospitalizations due to RT PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2