Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
Brief Summary: The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years.

Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.


Options:
A: 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)
B: 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))
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: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))

Answer: C