Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Versus Intramuscularly in Adults Aged 50 Years or Older
Brief Summary: The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.


Options:
A: 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))
B: Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) (Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)); Anti-gE Antibody Concentrations (Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)); Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations (At two months after Dose 1 (M2) and one month after Dose 2 (M3)); Descriptive Statistics of Anti-gE Antibody Concentrations (Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)); Number of Subjects With Solicited Local Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses); Number of Subjects With Solicited General Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses); Mean Number of Days With Local Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D)); Mean Number of Days With General Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D)); Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) (From Month 0 to Month 3); Number of Subjects With Unsolicited Adverse Events (AEs) (Within 30 days (Days 0-29) post vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (From Month 0 to Month 3)
C: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)
D: Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). (At one month (M1) after Dose 2); Concentrations of Antibodies Against Anti-gE as Determined by ELISA. (At one month (M1) after Dose 2)

Answer: B