Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, D46/NS2/N/ΔM2-2-HindIII, Lot RSV#011B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age
Brief Summary: The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants and children 6 to 24 months of age.

This study was a companion study to CIR 313.


Options:
A: Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 1); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 3); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 7); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 30); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 31); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 33); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 37); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 60); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 180); Number of Subjects With Haematological and Biochemical Laboratory Abnormalities (At Day 360); Number of Subjects With Haematological and Biochemical Results by Maximum Grade (From Day 1 to Day 60); Number of Subjects With Unsolicited Adverse Events (AEs) (During the 30-day (Days 0-29) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (From Day 0 to Day 360)
B: Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load (Twice daily on Day 2 through Day 11 and once on Day 12)
C: Number of Participants With Solicited Adverse Events (AEs) by Grade (Measured from Day 0 through Day 28); Number of Participants With Unsolicited AEs by Grade (Measured from Day 0 through Day 28); Number of Participants With Serious Adverse Events (SAEs) (Measured from Day 0 through Day 56); Number of Participants Infected With RSV Vaccine Virus (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies); Peak Titer of Vaccine Virus Shed (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28); Duration of Vaccine Virus Shedding in Nasal Washes (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.); Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer (Measured at Day 0 and Day 56); Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) (Measured at Day 56)
D: Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 (Day 14 after dosing through end of surveillance period (approximately 7 months))

Answer: C