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Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Herpes zoster vaccine (GSK 1437173A)
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring Immunogenicity, Safety, Herpes zoster, Vaccination, Haematologic malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • A male or female, aged 18 years or older at the time of study entry.
  • Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition.
  • Life expectancy greater than or equal to 12 months, as assessed by the investigator.

  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

  • Female subjects of childbearing potential may be enrolled inthe study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled).
  • Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy.
  • Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure).
  • Human immunodeficiency virus (HIV) infection by clinical history.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.
  • Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
  • Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
  • Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine.
  • Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo).

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaccine Group

Placebo Group

Arm Description

Subjects will receive the candidate HZ vaccine (GSK 1437173A).

Subjects will receive the placebo vaccine.

Outcomes

Primary Outcome Measures

Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations
Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE [4x97 milli-international units per milliliter (mIU/mL)]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
Adjusted Geometric Mean Concentration of Anti-gE Antibodies
The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
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 Days With Solicited Local Symptoms
Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary or tympanic route measured 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 > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Days With Solicited General Symptoms
Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.
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. It also included 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)
A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination
Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMds assessed by the investigator as causally related to the study vaccination

Secondary Outcome Measures

Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.
Anti-gE Antibody Concentrations
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).This parameter was assessed in subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.
Time to Occurrence of Any Confirmed HZ Case
Time to occurrence of any confirmed HZ case is expressed in terms of incidence rate of subjects with at least one event. Hence, person-year rate = number of episodes (n)/ sum of follow-up period (censored at the first occurrence of an event) expressed in years (T[year)]). Follow-up period starts Day 1 of vaccination. Any clinically suspected case of HZ (defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings suggestive of VZV infection in the absence of characteristic HZ or VZV rash.) The endpoint is confirmed in two ways: (1) By Polymerase Chain Reaction (PCR) or (2) By the HZ Ascertainment Committee. The PCR is used as primary classification method.
Anti-gE Antibody Concentrations
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). This parameter was assessed in all vaccinated subjects.
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. Vaccine response was measured in all subjects.
Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers
Among markers expressed were interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS).
Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers
Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/106 CD4+ T cells). For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.
Number of Subjects With Serious Adverse Events (SAEs)
A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies
GMCs of anti-gE antibodies were tabulated per study group and HZ confirmed/non-confirmed status and expressed in milli-international units per milliliter (mIU/mL).
Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations
MGI was tabulated per study group and HZ confirmed/non-confirmed status. MGI was defined as the Geometric mean of the within subject ratios of the post-vaccination reciprocal anti-gE concentration to the Month 0 reciprocal anti-gE concentration.

Full Information

First Posted
January 10, 2013
Last Updated
May 31, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01767467
Brief Title
Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers
Official Title
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (undefined)
Primary Completion Date
January 7, 2016 (Actual)
Study Completion Date
January 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.
Detailed Description
Amendment to protocol posting: Increase in sample size, update of country/region-specific information (Sections 5, 6 and 9). Promotion of secondary to primary objective; related update of primary and secondary outcome measures (Sections 4 and 7).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Immunogenicity, Safety, Herpes zoster, Vaccination, Haematologic malignancies

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine Group
Arm Type
Experimental
Arm Description
Subjects will receive the candidate HZ vaccine (GSK 1437173A).
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive the placebo vaccine.
Intervention Type
Biological
Intervention Name(s)
Herpes zoster vaccine (GSK 1437173A)
Intervention Description
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.
Primary Outcome Measure Information:
Title
Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations
Description
Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE [4x97 milli-international units per milliliter (mIU/mL)]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
Time Frame
At Month 2
Title
Adjusted Geometric Mean Concentration of Anti-gE Antibodies
Description
The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
Time Frame
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 following each dose and across doses
Title
Number of Days With Solicited Local Symptoms
Description
Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.
Time Frame
Within the 7-day (Days 0-6) post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary or tympanic route measured 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 > 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 following each dose and across doses
Title
Number of Days With Solicited General Symptoms
Description
Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.
Time Frame
Withing the 7-day (Day 0-6) post-vaccination period
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. It also included 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
A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination
Time Frame
From first vaccination up to 30 days post last vaccination
Title
Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)
Description
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMds assessed by the investigator as causally related to the study vaccination
Time Frame
From first vaccination up to 30 days post last vaccination
Secondary Outcome Measure Information:
Title
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Description
Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.
Time Frame
At Month 2
Title
Anti-gE Antibody Concentrations
Description
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).This parameter was assessed in subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.
Time Frame
At Month 2
Title
Time to Occurrence of Any Confirmed HZ Case
Description
Time to occurrence of any confirmed HZ case is expressed in terms of incidence rate of subjects with at least one event. Hence, person-year rate = number of episodes (n)/ sum of follow-up period (censored at the first occurrence of an event) expressed in years (T[year)]). Follow-up period starts Day 1 of vaccination. Any clinically suspected case of HZ (defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings suggestive of VZV infection in the absence of characteristic HZ or VZV rash.) The endpoint is confirmed in two ways: (1) By Polymerase Chain Reaction (PCR) or (2) By the HZ Ascertainment Committee. The PCR is used as primary classification method.
Time Frame
From Month 0 until study end (Month 13)
Title
Anti-gE Antibody Concentrations
Description
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). This parameter was assessed in all vaccinated subjects.
Time Frame
At Months 0, 1, 2 and 13
Title
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Description
Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. Vaccine response was measured in all subjects.
Time Frame
At Months 1, 2 and 13
Title
Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers
Description
Among markers expressed were interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS).
Time Frame
At Months 0, 1, 2 and 13
Title
Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers
Description
Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/106 CD4+ T cells). For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.
Time Frame
At Months 1, 2 and 13
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination
Time Frame
From first vaccination at Month 0 up to study end at Month 13
Title
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Description
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
Time Frame
From first vaccination at Month 0 up to study end at Month 13
Title
Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies
Description
GMCs of anti-gE antibodies were tabulated per study group and HZ confirmed/non-confirmed status and expressed in milli-international units per milliliter (mIU/mL).
Time Frame
At Months 0 and 2
Title
Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations
Description
MGI was tabulated per study group and HZ confirmed/non-confirmed status. MGI was defined as the Geometric mean of the within subject ratios of the post-vaccination reciprocal anti-gE concentration to the Month 0 reciprocal anti-gE concentration.
Time Frame
At Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol. Written informed consent obtained from the subject. A male or female, aged 18 years or older at the time of study entry. Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition. Life expectancy greater than or equal to 12 months, as assessed by the investigator. Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. Female subjects of childbearing potential may be enrolled inthe study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled). Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy. Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure). Human immunodeficiency virus (HIV) infection by clinical history. Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed. Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo. Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine. Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo).
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
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
GSK Investigational Site
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
GSK Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
GSK Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
GSK Investigational Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
GSK Investigational Site
City
Coburg
State/Province
Victoria
ZIP/Postal Code
3058
Country
Australia
Facility Name
GSK Investigational Site
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
GSK Investigational Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
GSK Investigational Site
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
GSK Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
GSK Investigational Site
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
GSK Investigational Site
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
GSK Investigational Site
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
GSK Investigational Site
City
Pessac cedex
ZIP/Postal Code
33604
Country
France
Facility Name
GSK Investigational Site
City
Périgueux cedex
ZIP/Postal Code
24019
Country
France
Facility Name
GSK Investigational Site
City
Rouen cedex 1
ZIP/Postal Code
76038
Country
France
Facility Name
GSK Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Meldola (FC)
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
GSK Investigational Site
City
Udine
State/Province
Friuli-Venezia-Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
GSK Investigational Site
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Facility Name
GSK Investigational Site
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jellanamdo
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Kyunggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
GSK Investigational Site
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
GSK Investigational Site
City
Lahore
Country
Pakistan
Facility Name
GSK Investigational Site
City
Multan
Country
Pakistan
Facility Name
GSK Investigational Site
City
Panama
Country
Panama
Facility Name
GSK Investigational Site
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
GSK Investigational Site
City
Opole
ZIP/Postal Code
45-372
Country
Poland
Facility Name
GSK Investigational Site
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St'Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
197 089
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
GSK Investigational Site
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28933
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
GSK Investigational Site
City
Majadahonda (Madrid)
ZIP/Postal Code
28222
Country
Spain
Facility Name
GSK Investigational Site
City
Pozuelo De Alarcón/Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
GSK Investigational Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
GSK Investigational Site
City
Eskilstuna
ZIP/Postal Code
SE-631 88
Country
Sweden
Facility Name
GSK Investigational Site
City
Karlskrona
ZIP/Postal Code
SE-371 41
Country
Sweden
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taoyuan Hsien
ZIP/Postal Code
333
Country
Taiwan
Facility Name
GSK Investigational Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
GSK Investigational Site
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
GSK Investigational Site
City
Orpington
State/Province
Kent
ZIP/Postal Code
BR6 8ND
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Airdrie
State/Province
Lanarkshire
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Headington, Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE13 6LH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31399377
Citation
Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macias G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, Lopez-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6. Erratum In: Lancet Infect Dis. 2020 Jan;20(1):e1.
Results Reference
derived

Learn more about this trial

Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

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