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 and Children 6 to 24 Months of Age
Brief Summary: The purpose of this study is 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 is a companion study to IMPAACT 2012.


Options:
A: Frequency of vaccine-related reaction events and other adverse events in each cohort (Throughout study); Amount of vaccine virus shed by each participant (Throughout study); Amount of serum antibody and mucosal antibody induced by the vaccine in each participant (Throughout study)
B: Grades of study product-related solicited adverse events (AEs) (Measured through Day 28); Grades of study product-related unsolicited AEs (Measured through Day 28); Grades of study product-related serious adverse events (SAEs) (Measured through Day 56); Number of participants with infection with vaccine virus (Measured through Day 56); Peak titer of vaccine virus shed (Measured through Day 28); Duration of vaccine virus shedding in nasal washes measured by culture (Measured through Day 28); Duration of vaccine virus shedding in nasal washes measured by RT-PCR (Measured through Day 28); Frequency of a greater than or equal to 4-fold rise in RSV-neutralizing antibody titer (Measured through Day 56); Antibody responses to RSV F glycoprotein as assessed by enzyme-linked immunosorbent assay (ELISA) (Measured through Day 56)
C: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study (Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through follow-up period, up to 1 year after study entry)
D: 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)

Answer: B