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

NCT ID: NCT02979639

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-16
• Study Completion Date: 2018-05-24

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK1437173A Group

Subjects ≥ 50 years of age who will receive two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.

Group Type: EXPERIMENTAL

GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)

Intervention Type: BIOLOGICAL

2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm on a 2 month schedule.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the questionnaires and diary cards).
• Written informed consent obtained from the subject prior to performance of any study specific procedure.
• A male or female aged ≥ 50 YOA at the time of consent.
• Female subjects of non-childbearing potential may be enrolled in the study.

• For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

• Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
• Use or planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccine or current participation or planned concurrent participation in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device) during the period starting 30 days before the first dose of study vaccine and the study end.
• Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to study start and during the whole study period. This includes chronic administration of corticosteroids (> 14 consecutive days of prednisone at a dose of ≥ 20 mg/day [or equivalent]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). Inhaled, topical and intra-articular corticosteroids are allowed.
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
• Administration of immunoglobulins and/or any blood products in the period starting 90 days preceding the first dose of study vaccine or planned administration during the study period.
• Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine in the period starting 15 days prior to and ending 14 days after either dose of study vaccine.
• Previous or planned administration of a vaccine against HZ (including an investigational or non-registered vaccine) other than the study vaccine, during the entire study period.
• History of HZ.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Pregnant or lactating female.
• Significant underlying illness requiring medications that might confound the evaluation of general/ local AEs, or in the opinion of the investigator, would be expected to prevent completion of the study.
• Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Meridian, Idaho, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Corvallis, Oregon, United States

GSK Investigational Site

Uniontown, Pennsylvania, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Norfolk, Virginia, United States

Countries

United States

References

Schmader KE, Levin MJ, Grupping K, Matthews S, Butuk D, Chen M, Idrissi ME, Fissette LA, Fogarty C, Hartley P, Klein NP, Nevarez M, Uusinarkaus K, Oostvogels L, Curran D. The Impact of Reactogenicity After the First Dose of Recombinant Zoster Vaccine on the Physical Functioning and Quality of Life of Older Adults: An Open-Label, Phase III Trial. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1217-1224. doi: 10.1093/gerona/gly218.

Reference Type: DERIVED

PMID: 30256905 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

204928

Identifier Type: -

Identifier Source: org_study_id