Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)
Brief Summary: There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects.

"The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed infants \<3 months old with RSV bronchiolitis will result in fewer infants with readmissions to infirmary/observation or hospital for relapse during 3 weeks of follow-up after discharge".


Options:
A: Number of Subjects Reporting Serious Adverse Events (SAEs) (Day 0 - Day 150); Number of Subjects Reporting Adverse Events (AEs) (Day 0 - Day 150); Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs. (Day 0 - Day 150)
B: Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge (3 weeks)
C: 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)
D: 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))

Answer: B