Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of Different Formulations of GSK Biologicals' Herpes Zoster Vaccine 1437173A When Administered Twice in Adults Aged 50 Years and Older
Brief Summary: The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.


Options:
A: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Titers of H1N1-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of H3N2-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4))
B: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Anti-glycoprotein E (gE) Antibody Concentrations (One month after the second vaccination (Month 3)); Anti-VZV Antibody Concentrations (One month after the second vaccination (Month 3))
C: 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))
D: Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies (Baseline and 6 weeks following vaccine administration); Number of Participants Reporting an Adverse Experience (AE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (SAE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (Within 5 days after the blood draw at approximately 20 months following vaccine administration); Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) (Up to 5 days following vaccine administration); Number of Participants Reporting Systemic Adverse Experiences (Up to 42 days following vaccine administration); Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) (Up to 42 days following vaccine administration)

Answer: B