Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02052596
First received: January 23, 2014
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Biological: Herpes Zoster vaccine GSK 1437173A
Biological: Boostrix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Boostrix® in Adults Aged 50 Years and Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HZ/su immunogenicity in terms of vaccine response [ Time Frame: Vaccine response at one month post dose 2 (Month 3) for Co-Ad group ] [ Designated as safety issue: No ]
  • Boostrix immunogenicity in terms of antibody concentrations [ Time Frame: At one month post-dose (Month 1) ] [ Designated as safety issue: No ]
  • HZ/su immunogenicity in terms of antibody concentrations [ Time Frame: Antibody concentrations at one month post-dose 2 (Month 3 for the Co-Ad group and Month 5 for the Control group) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 7 days (Day 0-Day 6) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events (AEs) [ Time Frame: Within 30 days (Day 0-Day 29) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: From first vaccination up to study end (Day 0 to Month 14) ] [ Designated as safety issue: No ]
  • Occurrence of potential Immune Mediated Diseases (pIMDs) [ Time Frame: From first vaccination up to study end (Day 0 to Month 14) ] [ Designated as safety issue: No ]

Estimated Enrollment: 820
Study Start Date: February 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Co-Ad Group
Subjects will receive one injection of Boostrix vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
Biological: Herpes Zoster vaccine GSK 1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.
Biological: Boostrix
1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.
Active Comparator: Control Group
Subjects will receive all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
Biological: Herpes Zoster vaccine GSK 1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.
Biological: Boostrix
1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female aged 50 years or older at the time of the first vaccination with the study vaccine(s).
  • Written informed consent obtained from the subject.
  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, 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:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines (e.g., inactivated and subunit influenza vaccines).
  • Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ or VZV vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
  • History of HZ.
  • Vaccination against diphtheria, or tetanus in the last five years or planned vaccination against diphtheria or tetanus during the study period, other than the study vaccine(s).
  • Administration of a combined tetanus, diphtheria and pertussis (Tdap) vaccine at any time prior to study entry.
  • 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).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines including prior severe allergic reaction following tetanus-toxoid, diphtheria-toxoid or pertussis-containing vaccine.
  • Hypersensitivity to latex. Note: The investigational HZ/su vaccine does not contain latex.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  • Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
  • Encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) not attributable to an identifiable cause within 7 days of administration of a previous pertussis antigen-containing vaccine.
  • Progressive or unstable neurologic disorder.
  • History of Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine within the last 10 years.
  • History of Guillain-Barré syndrome within 6 weeks of receipt of a prior vaccine containing tetanus toxoid.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052596

Locations
United States, Arizona
GSK Investigational Site
Tucscon, Arizona, United States, 85704
United States, California
GSK Investigational Site
San Diego, California, United States, 92108
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, Idaho
GSK Investigational Site
Meridian, Idaho, United States, 83642
United States, Maine
GSK Investigational Site
Lewiston, Maine, United States, 04240
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Salisbury, North Carolina, United States, 28114
United States, Pennsylvania
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29650
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02052596     History of Changes
Other Study ID Numbers: 116887
Study First Received: January 23, 2014
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Boostrix
Herpes zoster
Immunogenicity
Co-administration
Adults
Safety

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014