Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Boostrix® in Adults Aged 50 Years and Older
Brief Summary: The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.


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 a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group (At 1 month post-Dose 2 (Month 3)); Antibody Concentrations Against Glycoprotein E (Anti-gE) (At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)); Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens (At 1 month post-Dose 1 (Month 1)); Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens (At 1 month post-Dose 1 (Month 1))
D: Number of Subjects With Vaccine Response to Anti-gE Antibodies (At one month post-dose 2 (Month 3)); Vaccine Response for Anti-gE Humoral Immunogenicity (At one month post-dose 2 (Month 3)); Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies (At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)); FLU Haemagglutination Inhibition (HI) Antibody Titers (At Day 21 post vaccination)

Answer: C