Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged >= 70 Years

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: October 16, 2014
Last verified: October 2014

July 15, 2010
October 16, 2014
August 2010
April 2016   (final data collection date for primary outcome measure)
  • Confirmed HZ cases [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
  • Postherpetic Neuralgia (PHN) cases [ Time Frame: 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 and Zoster-022: Occurrence of overall PHN in subjects >= 50 years of age (YOA) [ Time Frame: 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 and Zoster-022: Occurrence of confirmed HZ in subjects >= 70 YOA [ Time Frame: 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 and Zoster-022:Occurrence of overall PHN in subjects >= 70 YOA [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01165229 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: 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 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: 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 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: 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 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of unsolicited AEs in subjects >= 70 YOA [ Time Frame: 30 days (Days 0-29) after each vaccination ] [ Designated as safety issue: No ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of SAEs in subjects >= 70 YOA [ Time Frame: From Month 0 to Month 14 ] [ Designated as safety issue: No ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: 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 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of fatal SAEs [ Time Frame: 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 and Zoster-022: Occurrence of pre-defined AEs in subjects >= 70 YOA [ Time Frame: 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 and Zoster-022: Occurrence of medically attended visits in subjects >= 70 YOA [ Time Frame: From Month 0 to Month 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged >= 70 Years
Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged >= 70 Years

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 and Zoster-022) will be conducted concurrently to evaluate efficacy of GSK Biologicals' 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Herpes Zoster
  • Biological: Herpes Zoster Vaccine GSK1437173A
    Intramuscular injection
  • Biological: Placebo
    Intramuscular injection.
  • Experimental: Group A
    Not Applicable
    Intervention: Biological: Herpes Zoster Vaccine GSK1437173A
  • Placebo Comparator: Group B
    Not Applicable
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
14512
July 2016
April 2016   (final data collection date for primary outcome measure)

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;
  • 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 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.
Both
70 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Italy,   United States,   Australia,   Brazil,   Canada,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Hong Kong,   United Kingdom,   Japan,   Korea, Republic of,   Mexico,   Spain,   Sweden,   Taiwan
 
NCT01165229
113077
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP