Back to resultsImmunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Herpes zoster vaccine GSK1437173A
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Zoster focused on measuring Cytokine, Vaccine, Herpes Zoster (HZ), Cell mediated immunity (CMI), Antibody response, Varicella Zoster Virus (VZV), Shingles
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
GSK1437173A formulation 1 Group
GSK1437173A formulation 2 Group
GSK1437173A formulation 3 Group
Control Group
Arm Description
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) GSK1437173A formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Outcomes
Primary Outcome Measures
Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Anti-glycoprotein E (gE) Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Anti-VZV Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Secondary Outcome Measures
Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Anti-gE Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Anti-VZV Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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.
Number of Subjects With Serious Adverse Events (SAEs)
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.
Number of Subjects With Serious Adverse Events (SAEs)
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.
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
A suspected case of HZ was defined as a rash consistent with HZ.
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
A suspected case of HZ is defined as a rash consistent with HZ.
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00802464
Brief Title
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 12, 2009 (Actual)
Primary Completion Date
July 2, 2010 (Actual)
Study Completion Date
July 2, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Cytokine, Vaccine, Herpes Zoster (HZ), Cell mediated immunity (CMI), Antibody response, Varicella Zoster Virus (VZV), Shingles
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
410 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK1437173A formulation 1 Group
Arm Type
Experimental
Arm Description
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Arm Title
GSK1437173A formulation 2 Group
Arm Type
Experimental
Arm Description
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) GSK1437173A formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Arm Title
GSK1437173A formulation 3 Group
Arm Type
Experimental
Arm Description
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Intervention Type
Biological
Intervention Name(s)
Herpes zoster vaccine GSK1437173A
Other Intervention Name(s)
gE/AS01E, gE/AS01B
Intervention Description
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo/Saline
Intervention Description
2 vaccinations at Months 0 and 2 with placebo
Primary Outcome Measure Information:
Title
Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers
Description
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Time Frame
One month after the second vaccination (Month 3)
Title
Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
Description
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Time Frame
One month after the second vaccination (Month 3)
Title
Anti-glycoprotein E (gE) Antibody Concentrations
Description
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time Frame
One month after the second vaccination (Month 3)
Title
Anti-VZV Antibody Concentrations
Description
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time Frame
One month after the second vaccination (Month 3)
Secondary Outcome Measure Information:
Title
Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
Description
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Time Frame
At Month 0 and at Month 2
Title
Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
Description
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Time Frame
At Month 0 and at Month 2
Title
Anti-gE Antibody Concentrations
Description
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time Frame
At Month 0 and at Month 2
Title
Anti-VZV Antibody Concentrations
Description
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time Frame
At Month 0 and at Month 2
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
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.
Time Frame
During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Description
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 7-day (Days 0-6)post-vaccination period after each dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
Within the 30-day (Days 0-29) post-vaccination period
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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.
Time Frame
From Month 0 up to Month 8
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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.
Time Frame
During the period after Month 8 up to the end of the study at Month 14
Title
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
Description
Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Time Frame
From Month 0 until Month 8
Title
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
Description
Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Time Frame
During the period after Month 8 up to the end of the study at Month 14
Title
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
Description
A suspected case of HZ was defined as a rash consistent with HZ.
Time Frame
From Month 0 until Month 8
Title
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
Description
A suspected case of HZ is defined as a rash consistent with HZ.
Time Frame
During the period after Month 8 up to the end of the study at Month 14
Title
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Description
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time Frame
At Month 0
Title
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Description
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time Frame
At Month 2
Title
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Description
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time Frame
At Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
GSK Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89130
Country
United States
Facility Name
GSK Investigational Site
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
Country
Spain
Facility Name
GSK Investigational Site
City
Mahadahonda( Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
GSK Investigational Site
City
Marid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com
Citations:
PubMed Identifier
23904292
Citation
Chlibek R, Bayas JM, Collins H, de la Pinta ML, Ledent E, Mols JF, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 2013 Dec 15;208(12):1953-61. doi: 10.1093/infdis/jit365. Epub 2013 Jul 31. Erratum In: J Infect Dis. 2021 Feb 3;223(2):353.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
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