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Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A 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:
NCT01165177
First received: July 15, 2010
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.

Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.


Condition Intervention Phase
Herpes Zoster
Biological: Herpes Zoster Vaccine GSK1437173A
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged ≥ 50 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Confirmed HZ cases [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Confirmed HZ cases during the study in the Modified Total Vaccinated Cohort (mTVc)


Secondary Outcome Measures:
  • Occurrence of overall Postherpetic Neuralgia (PHN) [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Incidence of PHN calculated using the mTVc

  • Duration of severe 'worst' HZ-associated pain [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ

  • Incidence of overall and HZ-related mortality [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
  • Incidence of HZ complications [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Incidence of HZ complications in subjects with confirmed HZ

  • Incidence of overall and HZ-related hospitalizations [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
  • Duration of pain medication administered for HZ [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Duration of pain medication administered for HZ in subjects with confirmed HZ

  • Occurrence of solicited local and general symptoms in a subset of subjects [ Time Frame: Within 7 days (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
    - Occurrence, intensity of each solicited local symptom in subjects included in the 7-day diary card subset; - Occurrence, intensity and relationship to vaccination of each solicited general symptom in subjects included in the 7-day diary card subset;

  • Occurrence of unsolicited adverse events (AEs) [ Time Frame: Within 30 days (Days 0 - 29) after each vaccination ] [ Designated as safety issue: No ]
    - Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects

  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Month 0 to Month 14 ] [ Designated as safety issue: No ]
    - Occurrence and relationship to vaccination of all SAEs in all subjects

  • Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine in all subjects [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
  • Occurrence of fatal SAEs [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
  • Occurrence of pre-defined AEs [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects

  • Occurrence of medically attended visits [ Time Frame: From Month 0 to Month 8 ] [ Designated as safety issue: No ]
    - Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.


Enrollment: 16256
Study Start Date: August 2010
Estimated Study Completion Date: July 2016
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoster vaccine group
Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule
Biological: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Placebo Comparator: Placebo group
Subjects will receive NaCl solution placebo according to a 0, 2-month schedule
Biological: Placebo
Intramuscular injection

Detailed Description:

This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints and the analyses of the objectives in 2 steps.

Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA, and other pre-specified endpoints will be analyzed.

  Eligibility

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

Inclusion Criteria:

  • Subjects who the investigator believes will comply with the requirements of the protocol;
  • Written informed consent obtained from the subject;
  • A male or female aged 50 years or older at the time of the first vaccination;
  • 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.

OR 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 urine 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 other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use 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 product;
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
  • History of HZ;
  • Previous vaccination against varicella or HZ;
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation;
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study;
  • Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period;
  • Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine;
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
  • Acute disease and/or fever at the time of enrollment;
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Pregnant or lactating female;
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  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: NCT01165177

  Show 216 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01165177     History of Changes
Other Study ID Numbers: 110390, 2008-000367-42
Study First Received: July 15, 2010
Last Updated: October 30, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Estonia: State Agency of Medicines
Spain: Agencia Española del Medicamento y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Mexico: Comisión Federal para la protección contra riezgos Sanitarios, Secretaría de Salud
Italy: General manager of Azienda Ospedaliera Universitaria San Martino di Genova
Taiwan: Department of Health
Brazil: ANVISA
Finland: FIMEA (Finnish Medicines Agency)
Hong Kong: Department of Health
Canada: Health Canada
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Germany: Paul-Ehrlich-Institut
Sweden: Medical Products Agency
Czech: State Institute for Drug Control
South Korea: Food and Drug Administration
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Herpes Zoster
subjects 50 years and older
immunogenicity
safety
vaccine
efficacy

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

ClinicalTrials.gov processed this record on November 20, 2014