Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged >= 50 Years

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: February 13, 2014
Last verified: January 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 and Zoster-022) 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. 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 ]

Secondary Outcome Measures:
  • Occurrence of overall Postherpetic Neuralgia (PHN) [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 overall and HZ-related hospitalizations [ Time Frame: 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 ]
  • 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 of unsolicited adverse events (AEs) [ Time Frame: 30 days (Days 0-29) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From Month 0 to Month 14 ] [ Designated as safety issue: No ]
  • 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 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 of medically attended visits [ Time Frame: From Month 0 to Month 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15980
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Biological: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Placebo Comparator: Group B
Not Applicable
Biological: Placebo
Intramuscular injection

  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
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
Study First Received: July 15, 2010
Last Updated: February 13, 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:
subjects 50 years and older
vaccine
immunogenicity
efficacy
Herpes Zoster
safety

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

ClinicalTrials.gov processed this record on April 15, 2014