Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged >= 50 Years
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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 |
- Confirmed HZ cases [ Time Frame: 3 to 5 year period following Day 0 ] [ Designated as safety issue: No ]
- 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: | March 2001 |
| 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 |
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
Show 216 Study Locations| 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: | 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 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 June 17, 2013