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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01165229
First received: July 15, 2010
Last updated: November 6, 2014
Last verified: November 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 ≥ 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

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 mTVc.

  • Outcome measure for the pooled analysis of combined data from studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): 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 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): Occurrence of confirmed HZ [ Time Frame: 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:
  • PHN cases [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - PHN cases in the mTVc.

  • Duration of severe 'worst' HZ-associated pain in subjects with confirmed HZ [ 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 overall and HZ-related mortality during the study

  • Incidence of HZ complications [ Time Frame: 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.

  • Incidence of overall and HZ-related hospitalizations [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Incidence of overall and HZ-related hospitalizations during the study.

  • 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 during the study in subjects with confirmed HZ.

  • Occurrence of solicited local and general symptoms in a subset of subjects [ Time Frame: 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.

  • Occurrence of unsolicited adverse events (AEs) [ Time Frame: 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.

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

  • Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine during the entire study period in all subjects.

  • Occurrence of fatal SAEs [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Occurrence of any fatal SAEs during the entire study period in all subjects.

  • 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) during the entire study period 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, 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): Occurrence of overall PHN in subjects ≥ 50 YOA [ Time Frame: 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): Occurrence of PHN in subjects ≥ 50 YOA with confirmed HZ [ Time Frame: 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): Duration of severe 'worst' HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ. [ 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 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): Occurrence of solicited local and general symptoms in subjects ≥ 70 YOA included in a subset of subjects [ Time Frame: 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): Occurrence of unsolicited AEs in subjects ≥ 70 YOA [ Time Frame: 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): Occurrence of SAEs in subjects ≥ 70 YOA [ Time Frame: From Month 0 to Month 14 ] [ 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): Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine 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): Occurrence of fatal SAEs [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
    - Occurrence of any fatal SAEs 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): Occurrence of pre-defined AEs in subjects ≥ 70 YOA [ Time Frame: 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): Occurrence of medically attended visits in subjects ≥ 70 YOA [ 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, from Month 0 to Month 8 in subjects ≥ 70 YOA.


Enrollment: 14512
Study Start Date: August 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: April 2016 (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
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 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: NCT01165229     History of Changes
Other Study ID Numbers: 113077, 2009-015791-94
Study First Received: July 15, 2010
Last Updated: November 6, 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
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:
Efficacy
Herpes Zoster
Safety
Adults
Vaccine
Immunogenicity
Subjects 70 years and older

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

ClinicalTrials.gov processed this record on November 27, 2014