Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults
Brief Summary: The goal of this study is to evaluate the safety, tolerability and immunogenicity of ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions. This study will also provide preliminary safety and immunogenicity data to support concurrent dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a dose previously assessed in the Phase 1a study.


Options:
A: Percentage of Participants With Solicited Symptoms (Day 1 to Day 7); Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) (From Day 1 to Day 29); Percentage of Participants With Treatment-emergent Serious Adverse Events (From Day 1 to Day 361); Percentage of Participants With New Onset Chronic Diseases (NOCDs) (From Day 1 to Day 361); Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) (From Day 1 to Day 361)
B: 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)
C: Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period); 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 vaccination at Day 0, up to Day 30 post-vaccination); Titres of RSV-A Neutralizing Antibodies (At Day 0 pre-vaccination); Titres of RSV-A Neutralizing Antibodies (At Day 30 post-vaccination)
D: 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))

Answer: A