Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID ΔM2-2, Lot RSV#007A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age
Brief Summary: Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around the world. This study will evaluate the safety and immune response to an RSV vaccine in RSV-seronegative infants and children.

This study is a companion study to IMPAACT 2000.


Options:
A: 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)
B: 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)
C: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
D: Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after the first product administration (Day 7)); Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after the second product administration (Day 91)); Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after each product administration); Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after the first product administration (Day 7)); Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after the second product administration (Day 91)); Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after each product administration); Number of Subjects With Abnormal Laboratory Measures of Safety (Day 0 through Day 308); Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) (Day 0 through Day 28 after product administration); Number of Subjects With Serious Adverse Events (SAEs) (Day 0 through Day 308); Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration (Day 0 through Day 308)

Answer: B