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Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00434577
Recruitment Status : Completed
First Posted : February 13, 2007
Results First Posted : January 8, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.


Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: Herpes Zoster vaccine GSK1437173A Low Dose Biological: Herpes Zoster vaccine GSK1437173A Medium Dose Biological: Herpes Zoster vaccine GSK1437173A High Dose Biological: Herpes Zoster vaccine GSK1437173A Modified Biological: Placebo Phase 2

Detailed Description:
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Phase II, Single-blind, Randomized, Controlled, Multicentre Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, gE/AS01B, and to Compare 3 Doses of gE With AS01B Adjuvant in Healthy Elderly Subjects, Aged 60 to 69 Years and 70 Years and Above.
Actual Study Start Date : February 14, 2007
Actual Primary Completion Date : October 4, 2007
Actual Study Completion Date : July 14, 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: GSK1437173A _LD Group
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.
Biological: Herpes Zoster vaccine GSK1437173A Low Dose
Single or two-dose intramuscular injection.

Experimental: GSK1437173A _MD Group
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Biological: Herpes Zoster vaccine GSK1437173A Medium Dose
Single or two-dose intramuscular injection.

Experimental: GSK1437173A _HD Group
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Biological: Herpes Zoster vaccine GSK1437173A High Dose
Single or two-dose intramuscular injection.

Placebo Comparator: Placebo + GSK1437173A _HD Group
Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Biological: Herpes Zoster vaccine GSK1437173A High Dose
Single or two-dose intramuscular injection.

Biological: Placebo
Single intramuscular injection

Active Comparator: GSK1437173A_MODIFIED GROUP
Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Biological: Herpes Zoster vaccine GSK1437173A Modified
Single or two-dose intramuscular injection.




Primary Outcome Measures :
  1. Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers [ Time Frame: One month after the second vaccination (Month 3) ]
    Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects aged 70 or higher (≥).

  2. Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers [ Time Frame: One month after the second vaccination (Month 3) ]
    Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level.

  3. Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers [ Time Frame: One month after the second vaccination (Month 3) ]
    Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old.


Secondary Outcome Measures :
  1. Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects 60 to 69 years (60-69y) and ≥ 70 years (+70y) old.

  2. Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  3. Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  4. Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  5. Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  6. Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  7. Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  8. Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  9. Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  10. Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

  11. Anti-gE Specific Antibody Concentrations [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  12. Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations [ Time Frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) ]
    Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA.

  13. Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers [ Time Frame: At Months 12, 24 and 36 ]
    Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

  14. Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker [ Time Frame: At Months 12, 24 and 36 ]
    Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

  15. Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker [ Time Frame: At Months 12, 24 and 36 ]
    Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

  16. Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker [ Time Frame: At Month 12, 24 and 36 ]
    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

  17. Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker [ Time Frame: At Month 12, 24 and 36 ]
    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

  18. Anti-gE Specific Antibody Concentrations [ Time Frame: At Months 12, 24 and 36 ]
    Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  19. Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations [ Time Frame: At Months 12, 24 and 36 ]
    Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

  20. Frequency of VZV-specific Memory B-cells in a Subset of Subjects [ Time Frame: At pre-vaccination (Day 0) and at Month 3 ]
    Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older.

  21. Number of Subjects With Different Biochemical and Haematological Levels [ Time Frame: At Day 0, Month 2 and Month 3 ]
    Among biochemical and haematological parameters assessed were albumin [ALB], alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], calcium [CAL], eosinophils [EOS], fibrinogen [FIB], haematocrit [HEM], hemoglobin [Hgb], leucocytes [LEU], lymphocytes [LYM], lactate dehydrogenate [LDH], monocytes [MON], neutrophils [NEU], partial thromboplastin time [PTPT], platelets [PLA], pro thrombin time [PTT], red blood cells [RBC], serum creatinine [SCREA], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.

  22. Number of German Subjects With Different Biochemical and Haematological Levels [ Time Frame: At one week post-vaccination 1 (Month 0) ]
    Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.

  23. Number of German Subjects With Different Biochemical and Haematological Levels [ Time Frame: At one week post-vaccination 2 (Month 2) ]
    Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.

  24. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  25. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  26. Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes [ Time Frame: From Month 0 to Month 3 ]
    Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.

  27. Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes [ Time Frame: From Month 3 up to Month 36 ]
    Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.

  28. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  29. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 0 to Month 3 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  30. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 3 to Month 12 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female aged 60 years or older at the time of the first vaccination.
  • Written informed consent obtained from the subject

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 injection with study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
  • Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
  • Previous vaccination against HZ.
  • History of herpes zoster (Shingles).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
  • 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.
  • History of or current drug and/or alcohol abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434577


Locations
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Czechia
GSK Investigational Site
Hradec Kralove, Czechia, 500 01
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
GSK Investigational Site
Berlin, Germany, 13347
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1018 WT
GSK Investigational Site
Rotterdam, Netherlands, 3011 EN
Sweden
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
GSK Investigational Site
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 108494
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 108494
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 108494
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 108494
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 108494
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 108494
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 108494
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00434577    
Other Study ID Numbers: 108494
108516 ( Other Identifier: GSK )
108518 ( Other Identifier: GSK )
108520 ( Other Identifier: GSK )
2006-004863-69 ( EudraCT Number )
First Posted: February 13, 2007    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: March 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
GSK Biologicals
Herpes Zoster (HZ)
Vaccine
Varicella Zoster Virus (VZV)
Shingles
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs