Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

February 22, 2019 updated by: GlaxoSmithKline

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.

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.

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

715

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hradec Kralove, Czechia, 500 01
        • GSK Investigational Site
      • Berlin, Germany, 13347
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68161
        • GSK Investigational Site
    • Bayern
      • Wuerzburg, Bayern, Germany, 97070
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1018 WT
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3011 EN
        • GSK Investigational Site
      • Eskilstuna, Sweden, SE-631 88
        • GSK Investigational Site
      • Uppsala, Sweden, SE-751 85
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.
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.
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.
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.
Single or two-dose intramuscular injection.
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.
Single or two-dose intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (≥).
One month after the second vaccination (Month 3)
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.
One month after the second vaccination (Month 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.
One month after the second vaccination (Month 3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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.
During the 30-day (Days 0-29) post-vaccination period
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.
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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).
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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.
At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
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.
At Months 12, 24 and 36
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.
At Months 12, 24 and 36
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.
At Months 12, 24 and 36
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.
At Month 12, 24 and 36
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.
At Month 12, 24 and 36
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).
At Months 12, 24 and 36
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).
At Months 12, 24 and 36
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.
At pre-vaccination (Day 0) and at Month 3
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.
At Day 0, Month 2 and Month 3
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.
At one week post-vaccination 1 (Month 0)
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.
At one week post-vaccination 2 (Month 2)
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.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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.
From Month 0 to Month 3
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.
From Month 3 up to Month 36
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.
From Month 0 to Month 3
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.
From Month 3 to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2007

Primary Completion (ACTUAL)

October 4, 2007

Study Completion (ACTUAL)

July 14, 2010

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (ESTIMATE)

February 13, 2007

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 108494
  • 108516 (OTHER: GSK)
  • 108518 (OTHER: GSK)
  • 108520 (OTHER: GSK)
  • 2006-004863-69 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 108494
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 108494
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 108494
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 108494
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 108494
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: 108494
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Study Protocol
    Information identifier: 108494
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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