NCT02979639

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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 description

The study will evaluate the impact of HZ/su vaccination on the QoL, 400 adults ≥ 50 years of age (YOA). Subjects will be asked to respond to a series of SF-36 and EQ-5D questionnaires before and after vaccination following a 2 month schedule. To estimate the impact of reactogenicity on an individual's physical functioning (PF) and QoL, the study will compare subject questionnaire responses made during two periods, i.e., pre-vaccination and post-vaccination. The difference will be considered to be the effect of vaccination and reactogenicity on the PF and QoL. To characterize the study population and determine if frailty may influence reactogenicity and consequently the impact on QoL scores, the subjects' frailty status will be assessed at the first inclusion visit. In addition to the SF-36 and EQ-5D questionnaires, a more complete characterization of the reactogenicity of the vaccine will be made by including a detailed collection of the use of healthcare resources and the occurrence of symptoms through diary card data collection. Impact on days of work loss, both for the subject or for a caregiver, as applicable, will also be assessed. Note that as a result of internal change in data standards terminology, the study data collected was converted to cDISC and the statistical analysis plan was amended accordingly. "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by "Day n+1". Thus, the timeframes (Day 0, Day n) of Outcome Measures described in this study record are different to that denoted in the full protocol document posted.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)	2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm on a 2 month schedule.

Timeline

• Start date: 2017-01-16
• Primary completion: 2017-04-12
• Completion: 2018-05-24
• First posted: 2016-12-01
• Last updated: 2019-10-08
• Results posted: 2018-10-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study