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

NCT02979639 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 204928
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 11

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

Conditions

Herpes Zoster

Keywords

Herpes Zoster; Reactogenicity; Quality of life; Shingles

Outcome Measures

Primary Outcomes (1)

• Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose

  Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.

  From Baseline at Day -7 to Day 8 after first dose

Secondary Outcomes (26)

• Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose

  From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

• Change in Mean SF-36 PF Single Item Scores After First Dose

  From Baseline at Day -7 to Day 8 after first dose

• Change in Mean SF-36 PF Single Item Scores After Second Dose

  From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

• Change in SF-36 Role Physical Scores After First Dose

  From Baseline at Day -7 to Day 8 after first dose

• Change in SF-36 Role Physical Scores After Second Dose

  From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

Study Arms (1)

GSK1437173A Group

EXPERIMENTAL

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.

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

Interventions

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

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

GSK1437173A Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Oakland, California, 94612, United States

Location

GSK Investigational Site

Aurora, Colorado, 80045, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80906, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80922, United States

Location

GSK Investigational Site

Meridian, Idaho, 83646, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64114, United States

Location

GSK Investigational Site

Durham, North Carolina, 27705, United States

Location

GSK Investigational Site

Corvallis, Oregon, 97330, United States

Location

GSK Investigational Site

Uniontown, Pennsylvania, 15401, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• 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.

  PMID: 30256905 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 1, 2016
• Study Start: January 16, 2017
• Primary Completion: April 12, 2017
• Study Completion: May 24, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 16, 2018

Record last verified: 2019-09

Locations

US (11)