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, LID cp ΔM2-2, Lot RSV#009B, 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 intranasal dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age.

This study was a companion study to CIR 312.


Options:
A: Number of Subjects With Abnormal Biochemical Laboratory Values. (At Day 7); Number of Subjects With Abnormal Biochemical Laboratory Values. (At Day 30); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 7); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 30); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 7); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 30); Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Haematology Change From Baseline by Maximum Grade (From Day 7 up to Day 30); Number of Subjects With Solicited Local Symptoms (During a 7-day follow-up period (from Day 0 to Day 6) after vaccination); Number of Subjects With Solicited General Symptoms (During a 7-day follow-up period (from Day 0 to Day 6) after vaccination); Number of Subjects With Unsolicited Adverse Events (AEs) (During a 30-day follow-up period (from Day 0 to Day 29) after vaccination); Number of Subjects With Serious Adverse Events (SAEs) (From vaccination (Day 0) up to study end (Day 30))
B: 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))
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 (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 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: Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study, the first 28 days after inoculation (Measured through Day 28); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through Day 56); Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study, the first 28 days after inoculation (Measured through Day 28)

Answer: C