Please select the outcome measures that correspond to the clinical trial below.
Title: 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)
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.


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: Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) (Through 150 Days Post Dose)
C: Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge (3 weeks)
D: 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)

Answer: B