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

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 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.

Condition	Intervention	Phase
Herpes Zoster Vaccine	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 of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged >= 70 Years

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Herpes Zoster Vaccine

U.S. FDA Resources

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 ]
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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	14512
Study Start Date:	January 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:	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;
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165229

Show 214 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
Study First Received:	July 15, 2010
Last Updated:	April 25, 2013
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:

vaccine
subjects 70 years and older
safety

Herpes Zoster
efficacy
immunogenicity

Additional relevant MeSH terms:

Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013