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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01767467
Registration number
NCT01767467
Ethics application status
Date submitted
10/01/2013
Date registered
14/01/2013
Date last updated
6/06/2018
Titles & IDs
Public 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
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Scientific title
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies
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Secondary ID [1]
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2012-003438-18
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Secondary ID [2]
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116428
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster
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Condition category
Condition code
Infection
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Other infectious diseases
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Herpes zoster vaccine (GSK 1437173A)
Treatment: Drugs - Placebo
Experimental: Vaccine Group - Subjects will receive the candidate HZ vaccine (GSK 1437173A).
Placebo Comparator: Placebo Group - Subjects will receive the placebo vaccine.
Other interventions: Herpes zoster vaccine (GSK 1437173A)
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.
Treatment: Drugs: Placebo
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.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations
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Assessment method [1]
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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.
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Timepoint [1]
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At Month 2
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Primary outcome [2]
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Adjusted Geometric Mean Concentration of Anti-gE Antibodies
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Assessment method [2]
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The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
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Timepoint [2]
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At Month 2
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Primary outcome [3]
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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Assessment method [3]
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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.
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Timepoint [3]
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Primary outcome [4]
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Number of Days With Solicited Local Symptoms
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Assessment method [4]
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Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.
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Timepoint [4]
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Within the 7-day (Days 0-6) post-vaccination period
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Primary outcome [5]
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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Assessment method [5]
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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.
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Timepoint [5]
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Primary outcome [6]
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Number of Days With Solicited General Symptoms
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Assessment method [6]
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Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.
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Timepoint [6]
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Withing the 7-day (Day 0-6) post-vaccination period
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Primary outcome [7]
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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Assessment method [7]
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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.
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Timepoint [7]
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Within the 30-day (Days 0-29) post-vaccination period
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Primary outcome [8]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [8]
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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
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Timepoint [8]
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From first vaccination up to 30 days post last vaccination
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Primary outcome [9]
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Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)
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Assessment method [9]
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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
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Timepoint [9]
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From first vaccination up to 30 days post last vaccination
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Secondary outcome [1]
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Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
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Assessment method [1]
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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.
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Timepoint [1]
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At Month 2
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Secondary outcome [2]
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Anti-gE Antibody Concentrations
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Assessment method [2]
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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.
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Timepoint [2]
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At Month 2
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Secondary outcome [3]
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Time to Occurrence of Any Confirmed HZ Case
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Assessment method [3]
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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.
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Timepoint [3]
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From Month 0 until study end (Month 13)
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Secondary outcome [4]
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Anti-gE Antibody Concentrations
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Assessment method [4]
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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.
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Timepoint [4]
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At Months 0, 1, 2 and 13
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Secondary outcome [5]
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Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
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Assessment method [5]
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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.
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Timepoint [5]
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At Months 1, 2 and 13
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Secondary outcome [6]
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Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers
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Assessment method [6]
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Among markers expressed were interferon-gamma (IFN-?), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS).
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Timepoint [6]
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At Months 0, 1, 2 and 13
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Secondary outcome [7]
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Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers
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Assessment method [7]
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Among markers expressed were IFN-?, IL-2, TNF-a 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.
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Timepoint [7]
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At Months 1, 2 and 13
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Secondary outcome [8]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [8]
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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
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Timepoint [8]
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From first vaccination at Month 0 up to study end at Month 13
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Secondary outcome [9]
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Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
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Assessment method [9]
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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
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Timepoint [9]
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From first vaccination at Month 0 up to study end at Month 13
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Secondary outcome [10]
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Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies
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Assessment method [10]
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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).
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Timepoint [10]
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At Months 0 and 2
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Secondary outcome [11]
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Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations
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Assessment method [11]
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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.
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Timepoint [11]
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At Month 2
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/01/2017
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Sample size
Target
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Accrual to date
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Final
568
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Darlinghurst
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Recruitment hospital [2]
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GSK Investigational Site - Hobart
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Recruitment hospital [3]
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GSK Investigational Site - Coburg
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Recruitment hospital [4]
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GSK Investigational Site - Wodonga
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3058 - Coburg
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Recruitment postcode(s) [4]
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3690 - Wodonga
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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North Carolina
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United States of America
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Washington
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United States of America
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Wisconsin
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Belgium
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State/province [9]
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Antwerpen
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Hasselt
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Belgium
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Jette
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Belgium
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Leuven
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Czechia
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Praha 2
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Finland
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Helsinki
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Finland
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Tampere
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France
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Montpellier cedex 5
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France
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Mulhouse
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France
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Nantes cedex 1
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France
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Pessac cedex
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France
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Périgueux cedex
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France
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Rouen cedex 1
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Hong Kong
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Hong Kong
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia-Giulia
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Italy
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Piemonte
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jellanamdo
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Kyunggi-do
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Korea, Republic of
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Seoul
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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Pakistan
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Lahore
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Pakistan
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Multan
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Panama
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Panama
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Poland
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Chorzow
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Poland
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Opole
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Poland
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Slupsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Petrozavodsk
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Russian Federation
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St'Petersburg
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Russian Federation
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St-Petersburg
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Majadahonda (Madrid)
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Spain
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Pozuelo De Alarcón/Madrid
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Spain
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Santander
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Sweden
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Eskilstuna
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Country [59]
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Sweden
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State/province [59]
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Karlskrona
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Country [60]
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Sweden
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State/province [60]
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Malmö
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Country [61]
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0
Sweden
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State/province [61]
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0
Uppsala
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Country [62]
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0
Taiwan
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State/province [62]
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Kaohsiung
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Country [63]
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0
Taiwan
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State/province [63]
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Taichung
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Country [64]
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0
Taiwan
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State/province [64]
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Taipei
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Country [65]
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Taiwan
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State/province [65]
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Taoyuan Hsien
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Country [66]
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Turkey
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State/province [66]
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Ankara
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Country [67]
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United Kingdom
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State/province [67]
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Kent
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Country [68]
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United Kingdom
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State/province [68]
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Lanarkshire
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Country [69]
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United Kingdom
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State/province [69]
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Wiltshire
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Country [70]
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United Kingdom
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State/province [70]
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Bournemouth
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Country [71]
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United Kingdom
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State/province [71]
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Headington, Oxford
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Country [72]
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United Kingdom
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State/province [72]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01767467
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01767467
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