Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00802464
First received: December 4, 2008
Last updated: October 21, 2010
Last verified: October 2010
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Purpose
The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Zoster Herpes Zoster Vaccine |
Biological: Herpes zoster vaccine GSK1437173A Biological: Placebo |
Phase 2 |
| 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: | Immunogenicity and Safety Study of Different Formulations of GSK Biologicals' Herpes Zoster Vaccine 1437173A When Administered Twice in Adults Aged 50 Years and Older |
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:
- Cell mediated immune response (CMI) in terms of frequencies of CD4 T cells specific for VZV antigens [ Time Frame: 1 month after second vaccination ] [ Designated as safety issue: No ]
- VZV-specific Ab concentrations [ Time Frame: 1 month after second vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cell-mediated immunity (CMI) in terms of frequencies of CD4 T cells specific for varicella-zoster virus (VZV) antigens [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
- CMI in terms of frequencies of CD8 T cells specific for VZV antigens [ Time Frame: Months 0, 2 and 3 ] [ Designated as safety issue: No ]
- VZV-specific Ab concentrations [ Time Frame: Months 0 and 2 ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of solicited adverse events (AEs) [ Time Frame: Days 0-6 after each vaccination ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of unsolicited AEs [ Time Frame: Days 0 to 29 after each vaccination ] [ Designated as safety issue: No ]
- Occurrence and relationship to vaccination of all serious AEs (SAEs) [ Time Frame: From Month 0 until 12 months following the last vaccination (Month 14) ] [ Designated as safety issue: No ]
- Occurrence and relationship to vaccination of all of all new onsets of autoimmune diseases (NOADs) [ Time Frame: from Month 0 until 12 months following the last vaccination (Month 14) ] [ Designated as safety issue: No ]
- Occurrence of suspected cases of Herpes Zoster (HZ) [ Time Frame: from Month 0 until 12 months following the last vaccination (Month 14) ] [ Designated as safety issue: No ]
- Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 0 [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
- Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 2 [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
- Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 3 [ Time Frame: Minth 3 ] [ Designated as safety issue: No ]
| Enrollment: | 410 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Formulation 1
|
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
|
|
Experimental: Group B
Formulation 2
|
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
|
|
Placebo Comparator: Group D
Placebo
|
Biological: Placebo
2 vaccinations at Months 0 and 2 with placebo
|
|
Experimental: Group C
Formulation 3
|
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A male or female 50 years of age or above at the time of the first vaccination;
- Written informed consent obtained from the subject;
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
- Previous vaccination against HZ;
- Previous vaccination against varicella;
- History of HZ;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
- Acute disease at the time of enrolment.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
- History of or current drug and/or alcohol abuse;
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802464
Locations
| United States, Arizona | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85020 | |
| United States, Florida | |
| GSK Investigational Site | |
| Pembroke Pines, Florida, United States, 33024 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89130 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Edison, New Jersey, United States, 08817 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44122 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15236 | |
| Czech Republic | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 01 | |
| Spain | |
| GSK Investigational Site | |
| Barcelona, Spain | |
| GSK Investigational Site | |
| Barcelona, Spain, 08035 | |
| GSK Investigational Site | |
| Mahadahonda( Madrid, Spain, 28222 | |
| GSK Investigational Site | |
| Marid, Spain, 28040 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00802464 History of Changes |
| Other Study ID Numbers: | 112077 |
| Study First Received: | December 4, 2008 |
| Last Updated: | October 21, 2010 |
| Health Authority: | Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení Spain: Agencia Española del Medicamento y Productos Sanitarios United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Cytokine Vaccine Herpes Zoster (HZ) Cell mediated immunity (CMI) |
Antibody response Varicella Zoster Virus (VZV) Shingles |
Additional relevant MeSH terms:
|
Herpes Zoster Herpesviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013