Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Single-blind, Randomized, Controlled, Multicentre Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, gE/AS01B, and to Compare 3 Doses of gE With AS01B Adjuvant in Healthy Elderly Subjects, Aged 60 to 69 Years and 70 Years and Above.
Brief Summary: Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 \& 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity \& safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.


Options:
A: Number of Subjects With a Vaccine Response for Anti-gE Antibodies (At Month 3); Anti-glicoprotein E (gE) Antibody Concentrations (At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)); Anti-pneumococcal Antibody Titers (At one month post-dose (Month 1)); Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups (At 1 month after vaccination); Adjusted GMCs Between Groups (At 1 month after last vaccine dose)
B: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))
C: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations (One month after dose 2, at Month 3); Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) (During the 30-day (Days 0-29) period after each dose.); Number of Subjects With Any and Related Serious Adverse Events (SAEs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)); Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3))
D: Number of Subjects With Any Episodes of Herpes Zoster (HZ) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ (During the entire study period (3 to 5 year period following Day 0))

Answer: B