Clinical Trial: Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GlaxoSmithKline (GSK) Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GSK Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK14371

Brief Summary: The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals' HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age.

Detailed Summary: The study will evaluate the impact of HZ/su vaccination on the QoL and physical functioning (PF) in 400 adults ≥ 50 years of age (YOA) via Patient Reported Outcome questionnaires SF-36 and EQ-5D. In addition to the SF-36 and EQ-5D questionnaires, further characterization of the reactogenicity of the vaccine will be made through diary card data collection.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Change in mean Short Form 36-item-health survey (SF 36) Physical Form (PF) scale score. [ Time Frame: From Baseline at Day -7 to day 7. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in mean SF-36 PF scale scores. [ Time Frame: From Baseline at Day -7 to Day 67. ]
  Descriptive analysis of the change in mean SF-36 PF scale score from baseline versus mean score over the period day 1 to day 7 after second vaccination.
• Change in mean SF-36 PF single item scores. [ Time Frame: From Baseline at Day -7 to Day 7 and from baseline at Day -7 to Day 67. ]
  Descriptive analysis of the change in mean SF-36 PF single item score from baseline versus mean score over the period day 1 to day 7 after each vaccination.
• Change in SF-36 Role Physical scores. [ Time Frame: From Baseline at Day -7 to Day 7 and from baseline at Day -7 to Day 67. ]
  Descriptive analysis. SF-36 Role physical scores change will be measured from baseline score versus score on day 7 after each vaccination.
• Change in Quality-adjusted life year (QALY). [ Time Frame: From Baseline at Day -7 to Day 7 and from baseline at day -7 to Day 67. ]
  Descriptive analysis. QALY estimation is done from baseline score versus combined score over the period day 1 to day 7 after each vaccination.
• Healthcare resource utilization. [ Time Frame: From Day 0 to Day 6 and day 60 to Day 66. ]
  Healthcare resource utilization corresponds to hospitalization, telephone calls, medical visits, specialist visits and medication intake.
• Work loss for subjects. [ Time Frame: Day 0 to Day 6 and day 60 to Day 66. ]
  Descriptive analysis. Estimation of work loss for vaccinated subjects.
• Work loss for the non-dedicated caregivers. [ Time Frame: Day 0 to Day 6 and day 60 to Day 66. ]
  Descriptive analysis. Estimation of work loss of non-dedicated caregivers.
• Extra work for dedicated caregivers. [ Time Frame: Day 0 to Day 6 and day 60 to Day 66. ]
  Descriptive analysis of the estimation of extra work of a dedicated caregiver.
• Numbers of subjects with solicited local symptoms. [ Time Frame: During the 7-day (Days 0-6) following each vaccination. ]
  Occurrence, intensity, and duration of solicited local symptoms pain, redness and swelling.
• Numbers of subjects with solicited general symptoms. [ Time Frame: During the 7-day (Days 0-6) following each vaccination. ]
  Occurrence, intensity, duration and relationship to vaccination of solicited general symptoms (fever [defined as oral/axillary temperature equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering).
• Numbers of subjects with unsolicited adverse events (AEs). [ Time Frame: During the 30-Day (Days 0-29) following each vaccination. ]
  Occurrence, intensity and relationship to vaccination, according to MedDRA classification.
• Numbers of subjects with serious adverse events (SAEs). [ Time Frame: From Day 0 up to study end at Month 14. ]
  Occurrence and relationship to vaccination of all SAEs.
• Number of subjects with adverse events of specific interest (AESIs): potential Immune-Mediated Diseases (pIMDs). [ Time Frame: From Day 0 up to study end at Month 14. ]
  Occurrence and relationship to vaccination of any pIMDs. PIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may not have an autoimmune aetiology.

Original Secondary Outcome:

• Change in mean SF-36 PF scale scores. [ Time Frame: From Baseline at Day -7 to Day 67. ]
  Descriptive analysis of the change in mean SF-36 PF scale score from baseline versus mean score over the period day 1 to day 7 after second vaccination.
• Change in mean SF-36 PF single item scores. [ Time Frame: From Baseline at Day -7 to Day 7 and from baseline at Day -7 to Day 67. ]
  Descriptive analysis of the change in mean SF-36 PF single item score from baseline versus mean score over the period day 1 to day 7 after each vaccination.
• Change in SF-36 Role Physical scores. [ Time Frame: From Baseline at Day -7 to Day 7 and from baseline at Day -7 to Day 67. ]
  Descriptive analysis. SF-36 Role physical scores change will be measured from baseline score versus score on day 7 after each vaccination.
• Change in Quality-adjusted life year (QALY). [ Time Frame: From Baseline at Day -7 to Day 7 and from baseline at day -7 to Day 67. ]
  Descriptive analysis. QALY estimation is done from baseline score versus combined score over the period day 1 to day 7 after each vaccination.
• Healthcare resource utilization. [ Time Frame: From Day 0 to Day 6 and day 60 to Day 66. ]
  Healthcare resource utilization corresponds to hospitalization, telephone calls, medical visits, specialist visits and medication intake.
• Work loss for subjects. [ Time Frame: Day 0 to Day 6 and day 60 to Day 66. ]
  Descriptive analysis. Estimation of work loss for vaccinated subjects.
• Work loss for the non-dedicated caregivers. [ Time Frame: Day 0 to Day 6 and day 60 to Day 66. ]
  Descriptive analysis. Estimation of work loss of non-dedicated caregivers.
• Extra work for dedicated caregivers. [ Time Frame: Day 0 to Day 6 and day 60 to Day 66. ]
  Descriptive analysis of the estimation of extra work of a dedicated caregiver.
• Numbers of subjects with solicited local symptoms. [ Time Frame: During the 7-day (Days 0-6) following each vaccination. ]
  Occurrence, intensity, and duration of solicited local symptoms pain, redness and swelling.
• Numbers of subjects with solicited general symptoms. [ Time Frame: During the 7-day (Days 0-6) following each vaccination. ]
  Occurrence, intensity, duration and relationship to vaccination of solicited general symptoms (fever [defined as oral/axillary temperature equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering).
• Numbers of subjects with unsolicited adverse events (AEs). [ Time Frame: During the 30-Day (Days 0-29) following each vaccination. ]
  Occurrence, intensity and relationship to vaccination, according to MedDRA classification.
• Numbers of subjects with serious adverse events (SAEs). [ Time Frame: From Day 0 up to study end at Month 14. ]
  Occurrence and relationship to vaccination of all SAEs.
• Number of subjects with adverse events of specific interest (AESIs): potential Immune-Mediated Diseases (pIMDs). [ Time Frame: From Day 0 up to study end at Month 14. ]
  Occurrence and relationship to vaccination of any pIMDs. PIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may not have an autoimmune aetology.

Information By: GlaxoSmithKline

Dates:
Date Received: November 29, 2016
Date Started: January 16, 2017
Date Completion: August 14, 2018
Last Updated: April 26, 2017
Last Verified: April 2017