Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness
Brief Summary: The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.


Options:
A: Percentage of Infant Participants With Medically Attended Lower Respiratory Tract Illness (MA-LRTI) Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy) (Within 90 days after birth); Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy) (Within 120 days after birth); Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy) (Within 150 days after birth); Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy) (Within 180 days after birth); Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy) (Within 90 days after birth); Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy) (Within 120 days after birth); Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy) (Within 150 days after birth); Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy) (Within 180 days after birth); Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety) (From birth to 24 months of age); Percentage of Infant Participants With Neonatal Deaths (Safety) (Within 1 Month after birth); Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety) (At birth); Percentage of Infant Participants With Other Neonatal Events (Safety) (Within 1 Month after birth); Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety) (1 minute after birth); Number of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety) (5 minutes after birth); Number of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety) (10 minutes after birth); Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety) (From birth to 1 month of age); Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety) (From birth to 6 months of age); Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety) (From birth to 12 months of age); Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety) (From birth to 24 months of age); Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination (Safety) (From Day 1 to Day 7 after vaccination); Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination (Safety) (From Day 1 to Day 7 after vaccination); Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety) (From vaccination on Day 1 up to 1 month after vaccination); Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety) (From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months))
B: 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) (360 days post first dose)
C: Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge (3 weeks)
D: Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0 (Day 0); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 (Day 1); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 (Day 2); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 (Day 3); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 (Day 4); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 (Day 5); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 (Day 6); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 (Day 7); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 (Day 30); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 (Day 90); RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180 (Day 180); Motavizumab Concentration in Nasal Wash Aspirates at Day 0 (Day 0); Motavizumab Concentration in Nasal Wash Aspirates at Day 1 (Day 1); Motavizumab Concentration in Nasal Wash Aspirates at Day 2 (Day 2); Motavizumab Concentration in Nasal Wash Aspirates at Day 7 (Day 7); Motavizumab Concentration in Nasal Wash Aspirates at Day 30 (Day 30)

Answer: D