Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults
Brief Summary: The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.


Options:
A: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
B: 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))
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: 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: D