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Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01751165
First received: December 13, 2012
Last updated: October 10, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.

Condition Intervention Phase
Herpes Zoster
Biological: Herpes zoster vaccine GSK1437173A
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: Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with vaccine response to anti-glycoprotein E (anti-gE) antibodies as determined by the enzyme-linked immunosorbent assay (ELISA). [ Time Frame: At one month (M1) after Dose 2 ] [ Designated as safety issue: No ]
    Vaccine response was defined as: for initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. The lower limit (LL) of the 97.5 % confidence interval (CI) of the VRR for anti-gE ELISA antibody concentrations at one month post-dose 2 in the 0,6-month or 0,12-month schedule groups was at least 60 %.

  • Concentrations of antibodies against anti-gE as determined by ELISA. [ Time Frame: At one month (M1) after Dose 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concentrations of antibodies against anti-gE as determined by ELISA. [ Time Frame: Prior (PRE) to vaccination and twelve (M12) post Dose 2 ] [ Designated as safety issue: No ]
  • Number of subjects with solicited local symptoms. [ Time Frame: During the 7 day period (Days 0-6) following each dose (D) ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling. "Grade 3 pain" was defined as crying when limb was moved/spontaneously painful. "Grade 3 swelling/redness" was defined as swelling/redness larger than (>) 100 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

  • Number of subjects with solicited general symptoms. [ Time Frame: During the 7 day period (Days 0-6) following each dose (D) ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]). "Any" = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. "Related" = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. "Grade 3 Fatigue" = fatigue that prevented normal activity. "Grade 3 Gastrointestinal" = gastrointestinal that prevented normal every day activities. "Grade 3 Headache" = headache that prevented normal activity. "Grade 3 Myalgia" = myalgia that prevented normal activity. "Grade 3 Shivering" = shivering that prevented normal activity. "Grade 3 Temperature" = temperature higher than (>) 39.0°C.

  • Number of subjects with unsolicited adverse events (AEs). [ Time Frame: During the 30 Days (Day 0-29) following vaccination ] [ Designated as safety issue: No ]
    An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  • Number of subjects with serious adverse events (SAEs). [ Time Frame: From first vaccination up to one month (30 Days) post last vaccination ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.

  • Number of subjects with SAE(s). [ Time Frame: Starting from 30 Days post last vaccine administration up to study end at Month 24 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.

  • Number of days with solicited local symptoms. [ Time Frame: During the 7 Days (Day 0-6) following vaccination ] [ Designated as safety issue: No ]
    Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.

  • Number of days with solicited general symptoms. [ Time Frame: During the 7 Days (Day 0-6) following vaccination ] [ Designated as safety issue: No ]
    Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.

  • Number of subjects with potential immune-mediated diseases (pIMDs). [ Time Frame: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2) ] [ Designated as safety issue: No ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  • Number of subjects with pIMDs. [ Time Frame: From one month (30 Days) following the last vaccine administration up to study end at Month 24 ] [ Designated as safety issue: No ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.


Enrollment: 354
Study Start Date: March 2013
Study Completion Date: April 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HZ/su-0,2 Group
Subjects will receive HZ/su vaccine on a 0,2-month schedule.
Biological: Herpes zoster vaccine GSK1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Experimental: HZ/su-0,6 Group
Subjects will receive HZ/su vaccine on a 0,6-month schedule.
Biological: Herpes zoster vaccine GSK1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Experimental: HZ/su-0,12 Group
Subjects will receive HZ/su vaccine on a 0,12-month schedule.
Biological: Herpes zoster vaccine GSK1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Detailed Description:
Subjects in each group will be stratified by age with a minimum of 35 subjects in each stratum (50-59 years of age (YOA) stratum, 60-69 YOA stratum and ≥ 70 YOA stratum).
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.
  • 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 two months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine.
  • Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine.
  • 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.
  • Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study).
  • Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
  • History of HZ.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • 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).
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 37.5°C (99.5°F) for oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) for rectal route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness (such as mild diarrhoea, 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 three months preceding the first dose of study vaccine or planned administration during the study period.
  • Significant underlying illness that, 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.
  • Pregnant or lactating female.
  • Female planning to become pregnant during the entire treatment period and for two months after completion of the vaccination series, or planning to discontinue contraceptive precautions (if of childbearing potential).
  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: NCT01751165

Locations
United States, California
GSK Investigational Site
Spring Valley, California, United States, 91978
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Pennsylvania
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Estonia
GSK Investigational Site
Tartu, Estonia, 50106
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01751165     History of Changes
Other Study ID Numbers: 116697  2012-004456-11 
Study First Received: December 13, 2012
Last Updated: October 10, 2016
Health Authority: Estonia: State Agency of Medicines
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
≥ 50 years of age
Herpes zoster
Safety
Immunogenicity
Adults

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016