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Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01165229
First received: July 15, 2010
Last updated: June 29, 2016
Last verified: June 2016
  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 ≥ 70 years.

Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be 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. This protocol posting 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, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with First or only episode of herpes zoster (HZ) [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    Confirmed HZ cases during the study in the mTVc.

  • Outcome measure for the pooled analysis of combined data from studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of subjects with post-herpetic neuralgia (PHN) [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with confirmed HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.


Secondary Outcome Measures:
  • Number of subjects with post-herpetic neuralgia (PHN) [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - PHN cases in the mTVc.

  • Number of days with severe 'worst' HZ-associated pain [ Time Frame: During the entire study period (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.

  • Number of subjects with confirmed HZ episode related mortality and hospitalizations [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
  • Number of subjects with overall mortality and HZ-related mortality [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Incidence of overall and HZ-related mortality during the study

  • Number of subjects with confirmed HZ episode related hospitalizations [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Incidence of overall and HZ-related hospitalizations during the study.

  • Number of subjects with HZ related complications [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Incidence of HZ complications during the study in subjects with confirmed HZ.

  • Number of subjects receiving pain medication associated with HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
  • Number of days with pain medication associated with HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
  • Number of subjects with solicited local symptoms [ Time Frame: Within the 7 days (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
    - Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; - Occurrence, intensity and relationship to vaccination of each solicited general symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset.

  • Number of subjects with solicited general symptoms [ Time Frame: Within the 7 days (Days 0-6) post-vaccination period ] [ Designated as safety issue: No ]
  • Number of subjects with unsolicited adverse events (AEs) [ Time Frame: Within the 30 days (Days 0-29) after each vaccination ] [ Designated as safety issue: No ]
    - Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects.

  • Number of subjects with any, related and fatal serious adverse events (SAEs) [ Time Frame: From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in all subjects.

  • Number of subjects with potential immune mediated diseases (pIMDs) [ Time Frame: During the entire study period (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) during the entire study period in all subjects

  • Number of subjects with Medically Attended events (MAEs) [ Time Frame: From Month 0 to Month 8 post-vaccination ] [ 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, from Month 0 to Month 8 in all subjects.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177)and Zoster-022 (NCT01165229): Overall number of subjects with PHN in subjects ≥ 50 YOA [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with a reduction of PHN incidence in subjects ≥ 50 YOA with confirmed HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Occurrence of PHN during the entire study period in all subjects with confirmed HZ.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of days with severe 'worst' HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ. [ Time Frame: During the entire study period (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 ZBPI in subjects ≥ 70 YOA with confirmed HZ

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of days with severe 'worst' HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ. [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any and Grade 3 solicited local symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
    • Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA;
    • Occurrence, intensity and relationship to vaccination of each solicited general symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA included in the 7-day diary card subset

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any, Grade 3 and related solicited general symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with unsolicited AEs in subjects ≥ 70 YOA [ 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 during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): number of subjects with any, related and fatal SAEs [ Time Frame: From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any pIMDs [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ] [ Designated as safety issue: No ]
    - Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with Medically Attended events (MAEs) [ Time Frame: From Month 0 to Month 8 post-vaccination ] [ 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, from Month 0 to Month 8 in subjects ≥ 70 YOA.


Enrollment: 14819
Study Start Date: August 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.
  Eligibility

Ages Eligible for Study:   70 Years and older   (Senior)
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 70 years or older at the time of the first vaccination.

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 enrolment.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  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: NCT01165229

  Show 215 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01165229     History of Changes
Other Study ID Numbers: 113077  2009-015791-94 
Study First Received: July 15, 2010
Last Updated: June 29, 2016
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
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:
Immunogenicity
Subjects 70 years and older
Efficacy
Herpes Zoster
Safety
Adults
Vaccine

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 September 30, 2016