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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/NCT01165229
Registration number
NCT01165229
Ethics application status
Date submitted
15/07/2010
Date registered
19/07/2010
Date last updated
27/04/2020
Titles & IDs
Public title
Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
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Scientific title
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
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Secondary ID [1]
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2009-015791-94
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Secondary ID [2]
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113077
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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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Herpes Zoster Vaccine
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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 GSK1437173A
Other interventions - Placebo
Experimental: Zoster vaccine group - Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule
Placebo Comparator: Placebo group - Subjects will receive NaCl solution placebo according to a 0, 2-month schedule
Other interventions: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Other interventions: Placebo
Intramuscular injection.
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Intervention code [1]
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Other interventions
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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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Number of Subjects With Any Episodes of Herpes Zoster (HZ)
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Assessment method [1]
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Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).
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Timepoint [1]
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During the entire study period (3 to 5 year period following Day 0)
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Primary outcome [2]
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Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)
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Assessment method [2]
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Incidence of PHN calculated using the mTVc during the entire study period in subjects = 70 years of age (YOA).
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Timepoint [2]
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During the entire study period (3 to 5 year period following Day 0)
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Primary outcome [3]
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
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Assessment method [3]
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Occurrence of confirmed HZ during the entire study period in subjects = 70 YOA.
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Timepoint [3]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [1]
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Number of Subjects With Post-herpetic Neuralgia (PHN)
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Assessment method [1]
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PHN cases in the mTVc.
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Timepoint [1]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [2]
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Number of Days With Severe 'Worst' HZ-associated Pain
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Assessment method [2]
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Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.
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Timepoint [2]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [3]
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Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
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Assessment method [3]
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The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.
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Timepoint [3]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [4]
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Number of Subjects With Overall Mortality and HZ-related Mortality
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Assessment method [4]
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The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.
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Timepoint [4]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [5]
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Number of Subjects With Confirmed HZ Episode Related Hospitalizations
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Assessment method [5]
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Incidence of overall and HZ-related hospitalizations during the study.
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Timepoint [5]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [6]
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Number of Subjects With HZ Related Complications
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Assessment method [6]
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Incidence of HZ complications during the study in subjects with confirmed HZ.
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Timepoint [6]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [7]
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Number of Subjects Receiving Pain Medication Associated With HZ
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Assessment method [7]
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Incidence of use of pain medications throughout the study
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Timepoint [7]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [8]
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Number of Days With Pain Medication Associated With HZ
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Assessment method [8]
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Incidence of reduction of duration of pain medication associated with HZ throughout the study.
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Timepoint [8]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [9]
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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Assessment method [9]
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Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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Timepoint [9]
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Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Secondary outcome [10]
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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Assessment method [10]
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Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering 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 > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
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Timepoint [10]
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Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Secondary outcome [11]
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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Assessment method [11]
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Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. 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.
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Timepoint [11]
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Within the 30 days (Days 0-29) after each vaccination
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Secondary outcome [12]
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Number of Subjects With Any and Related Serious Adverse Events (SAEs)
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Assessment method [12]
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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.
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Timepoint [12]
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From Month 0 to Month 14
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Secondary outcome [13]
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Number of Subjects With Fatal Serious Adverse Events (SAEs)
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Assessment method [13]
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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.
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Timepoint [13]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [14]
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Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication
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Assessment method [14]
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The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated
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Timepoint [14]
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During the entire study period (3 to 5 year period following day 0)
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Secondary outcome [15]
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Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
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Assessment method [15]
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Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects
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Timepoint [15]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [16]
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Number of Subjects With Any and Related Medically Attended Visits
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Assessment method [16]
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Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.
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Timepoint [16]
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From Month 0 to Month 8 post-vaccination
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Secondary outcome [17]
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects = 50 YOA
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Assessment method [17]
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Incidence of PHN calculated using the mTVc during the entire study period in subjects = 50 YOA.
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Timepoint [17]
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0
During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [18]
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects = 50 YOA With Confirmed HZ
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Assessment method [18]
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Occurrence of PHN during the entire study period in all subjects with confirmed HZ.
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Timepoint [18]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [19]
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects = 70 YOA With Confirmed HZ.
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Assessment method [19]
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The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects = 70 YOA with confirmed HZ .
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Timepoint [19]
0
0
During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [20]
0
0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects = 70 YOA With Confirmed HZ.
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Assessment method [20]
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Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects = 70 YOA with confirmed HZ.
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Timepoint [20]
0
0
During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [21]
0
0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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Assessment method [21]
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Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects = 70 YOA. 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 [21]
0
0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Secondary outcome [22]
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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Assessment method [22]
0
0
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering 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 = Temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
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Timepoint [22]
0
0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Secondary outcome [23]
0
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects = 70 YOA
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Assessment method [23]
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Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects = 70 YOA.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.
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Timepoint [23]
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0
Within 30 days (Days 0 - 29) after each vaccination
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Secondary outcome [24]
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs
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Assessment method [24]
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Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects = 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.
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Timepoint [24]
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From Month 0 to Month 14
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Secondary outcome [25]
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs
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Assessment method [25]
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Fatal SAEs during the entire study period in subjects = 70 YOA.
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Timepoint [25]
0
0
During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [26]
0
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Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs
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Assessment method [26]
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Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects = 70 YOA.
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Timepoint [26]
0
0
During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [27]
0
0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits
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Assessment method [27]
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Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects = 70 YOA.
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Timepoint [27]
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From Month 0 to Month 8 post-vaccination
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Eligibility
Key inclusion criteria
- Subjects who the investigator believes will comply with the requirements of the
protocol.
- Written informed consent obtained from the subject.
- A male or female aged 70 years or older at the time of the first vaccination.
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Minimum age
70
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?
Yes
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Key exclusion criteria
- Use of any investigational or non-registered product other than the study vaccine
within 30 days preceding the first dose of study vaccine, or planned use during the
study period.
- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
from disease or immunosuppressive/cytotoxic therapy History of HZ.
- Previous vaccination against varicella or HZ.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine. Additionally, consider allergic reactions to other material or equipment
related to study participation.
- Significant underlying illness that in the opinion of the investigator would be
expected to prevent completion of the study.
- Receipt of immunoglobulins and/or any blood products within the 90 days preceding the
first dose of study vaccine or planned administration during the study period.
- Administration or planned administration of any other immunizations within 30 days
before the first or second study vaccination or scheduled within 30 days after study
vaccination. However, licensed non-replicating vaccines may be administered up to 8
days prior to each dose and/or at least 14 days after any dose of study vaccine.
- Any other condition that, in the opinion of the investigator, might interfere with the
evaluations required by the study.
- Acute disease and/or fever at the time of enrolment.
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose.
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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
2/08/2010
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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
24/07/2015
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Sample size
Target
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Accrual to date
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Final
14819
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
0
0
GSK Investigational Site - Glebe
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Recruitment hospital [2]
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0
GSK Investigational Site - Maroubra
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Recruitment hospital [3]
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0
GSK Investigational Site - Umina
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Recruitment hospital [4]
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0
GSK Investigational Site - Westmead
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Recruitment hospital [5]
0
0
GSK Investigational Site - Wollongong
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Recruitment hospital [6]
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0
GSK Investigational Site - Caboolture
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Recruitment hospital [7]
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GSK Investigational Site - Kippa Ring
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Recruitment hospital [8]
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0
GSK Investigational Site - Geelong
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Recruitment hospital [9]
0
0
GSK Investigational Site - Ivanhoe
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Recruitment postcode(s) [1]
0
0
2037 - Glebe
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Recruitment postcode(s) [2]
0
0
2035 - Maroubra
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Recruitment postcode(s) [3]
0
0
2257 - Umina
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Recruitment postcode(s) [4]
0
0
2145 - Westmead
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Recruitment postcode(s) [5]
0
0
2522 - Wollongong
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Recruitment postcode(s) [6]
0
0
4510 - Caboolture
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Recruitment postcode(s) [7]
0
0
4021 - Kippa Ring
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Recruitment postcode(s) [8]
0
0
3220 - Geelong
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Recruitment postcode(s) [9]
0
0
3079 - Ivanhoe
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Idaho
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kansas
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Maryland
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Missouri
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Nevada
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Country [9]
0
0
United States of America
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State/province [9]
0
0
New Jersey
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Country [10]
0
0
United States of America
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State/province [10]
0
0
North Carolina
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Ohio
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Pennsylvania
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Country [13]
0
0
United States of America
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State/province [13]
0
0
South Carolina
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Tennessee
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Texas
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Utah
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Virginia
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Washington
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Country [19]
0
0
Brazil
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State/province [19]
0
0
Minas Gerais
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Country [20]
0
0
Brazil
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State/province [20]
0
0
Paraná
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Country [21]
0
0
Brazil
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State/province [21]
0
0
Rio Grande Do Sul
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Country [22]
0
0
Brazil
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State/province [22]
0
0
Curitiba/PR
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Country [23]
0
0
Brazil
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State/province [23]
0
0
São Paulo
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Country [24]
0
0
Canada
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State/province [24]
0
0
British Columbia
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Country [25]
0
0
Canada
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State/province [25]
0
0
Newfoundland and Labrador
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Country [26]
0
0
Canada
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State/province [26]
0
0
Nova Scotia
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Country [27]
0
0
Canada
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State/province [27]
0
0
Ontario
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Country [28]
0
0
Canada
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State/province [28]
0
0
Quebec
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Country [29]
0
0
Czechia
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State/province [29]
0
0
Brno
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Country [30]
0
0
Czechia
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State/province [30]
0
0
Ceske Budejovice
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Country [31]
0
0
Czechia
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State/province [31]
0
0
Hradec Kralove
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Country [32]
0
0
Estonia
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State/province [32]
0
0
Tallinn
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Country [33]
0
0
Estonia
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Finland
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Finland
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Finland
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Finland
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France
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France
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France
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Nantes
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France
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Rosiers d'Egletons
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France
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France
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France
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France
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Germany
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Germany
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Germany
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Germany
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Sachsen
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Germany
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Germany
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Berlin
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Germany
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Hamburg
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Hong Kong
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Kwun Tong
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Hong Kong
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Shatin
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Italy
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Abruzzo
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Italy
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Italy
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Italy
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Italy
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Piemonte
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Italy
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Sardegna
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Italy
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Fukuoka
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Tokyo
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Korea, Republic of
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Ansan
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Bucheon-si,
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Incheon
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Kangwon-do
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Mexico
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Mexico
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Centelles
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La Roca Del Valles (Barcelona)
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Madrid
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Taoyuan
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Lancashire
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Ledbury
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Newtonabbey
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United Kingdom
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Waterloo, Liverpool
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Funding & Sponsors
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Commercial sector/Industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
The purpose of this observer-blind study is to evaluate the efficacy, safety and
immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged = 70
years.
Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted
concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both
studies combined will be conducted contingent on each study achieving its objectives. This
protocol posting also deals with the outcome measures related to the pooled analysis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01165229
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Trial related presentations / publications
Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC; ZOE-70 Study Group. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.
Cunningham AL, Heineman TC, Lal H, Godeaux O, Chlibek R, Hwang SJ, McElhaney JE, Vesikari T, Andrews C, Choi WS, Esen M, Ikematsu H, Choma MK, Pauksens K, Ravault S, Salaun B, Schwarz TF, Smetana J, Abeele CV, Van den Steen P, Vastiau I, Weckx LY, Levin MJ; ZOE-50/70 Study Group. Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.
Ikematsu H et al. (2018) Efficacy, safety and immunogenicity of new adjuvanted herpes zoster subunit vaccine for Japanese over 50 years old and over 70 years old. Kansenshogaku Zasshi. 92(2):103-114.
Kovac M, Lal H, Cunningham AL, Levin MJ, Johnson RW, Campora L, Volpi A, Heineman TC; ZOE-50/70 Study Group. Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018 Mar 14;36(12):1537-1541. doi: 10.1016/j.vaccine.2018.02.029. Epub 2018 Feb 17.
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Public notes
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01165229
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