A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03959488|
Recruitment Status : Completed
First Posted : May 22, 2019
Results First Posted : September 21, 2023
Last Update Posted : September 21, 2023
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus Infections||Drug: MEDI8897 Drug: Palivizumab||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||925 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Actual Study Start Date :||July 30, 2019|
|Actual Primary Completion Date :||May 3, 2021|
|Actual Study Completion Date :||January 20, 2023|
anti-RSV monoclonal antibody with an extended half-life
Anti-RSV monoclonal antibody with an extended half-life
Active Comparator: Palivizumab
anti-RSV monoclonal antibody
Approved anti-RSV monoclonal antibody
- Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD) [ Time Frame: 360 days post first dose ]Safety and tolerability of MEDI8897 will be assessed by the occurrence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) , adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs)
- Serum Concentrations of MEDI8897 and Palivizumab [ Time Frame: Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2 ]Summary of individual MEDI8897 and palivizumab serum concentration data by treatment group along with descriptive statistics.
- Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum [ Time Frame: 360 days post first dose ]Incidence of ADA to MEDI8897 and palivizumab as assessed by the percentage of participants with any post-baseline ADA positive by treatment group.
- Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose [ Time Frame: 150 days post first dose ]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. Incidence of LRTI hospitalizations due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959488