Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01165229
Registration number
NCT01165229
Ethics application status
Date submitted
15/07/2010
Date registered
19/07/2010
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
Query!
Scientific title
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
Query!
Secondary ID [1]
0
0
2009-015791-94
Query!
Secondary ID [2]
0
0
113077
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster
0
0
Query!
Herpes Zoster Vaccine
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Herpes Zoster Vaccine GSK1437173A
Treatment: Other - 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
Treatment: Other: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Treatment: Other: Placebo
Intramuscular injection.
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Subjects With Any Episodes of Herpes Zoster (HZ)
Query!
Assessment method [1]
0
0
Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).
Query!
Timepoint [1]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Primary outcome [2]
0
0
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)
Query!
Assessment method [2]
0
0
Incidence of PHN calculated using the mTVc during the entire study period in subjects = 70 years of age (YOA).
Query!
Timepoint [2]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Primary outcome [3]
0
0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
Query!
Assessment method [3]
0
0
Occurrence of confirmed HZ during the entire study period in subjects = 70 YOA.
Query!
Timepoint [3]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [1]
0
0
Number of Subjects With Post-herpetic Neuralgia (PHN)
Query!
Assessment method [1]
0
0
PHN cases in the mTVc.
Query!
Timepoint [1]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [2]
0
0
Number of Days With Severe 'Worst' HZ-associated Pain
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [3]
0
0
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
Query!
Assessment method [3]
0
0
The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.
Query!
Timepoint [3]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [4]
0
0
Number of Subjects With Overall Mortality and HZ-related Mortality
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [5]
0
0
Number of Subjects With Confirmed HZ Episode Related Hospitalizations
Query!
Assessment method [5]
0
0
Incidence of overall and HZ-related hospitalizations during the study.
Query!
Timepoint [5]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [6]
0
0
Number of Subjects With HZ Related Complications
Query!
Assessment method [6]
0
0
Incidence of HZ complications during the study in subjects with confirmed HZ.
Query!
Timepoint [6]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [7]
0
0
Number of Subjects Receiving Pain Medication Associated With HZ
Query!
Assessment method [7]
0
0
Incidence of use of pain medications throughout the study
Query!
Timepoint [7]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [8]
0
0
Number of Days With Pain Medication Associated With HZ
Query!
Assessment method [8]
0
0
Incidence of reduction of duration of pain medication associated with HZ throughout the study.
Query!
Timepoint [8]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [9]
0
0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Query!
Secondary outcome [10]
0
0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Query!
Secondary outcome [11]
0
0
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Within the 30 days (Days 0-29) after each vaccination
Query!
Secondary outcome [12]
0
0
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
From Month 0 to Month 14
Query!
Secondary outcome [13]
0
0
Number of Subjects With Fatal Serious Adverse Events (SAEs)
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [14]
0
0
Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication
Query!
Assessment method [14]
0
0
The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated
Query!
Timepoint [14]
0
0
During the entire study period (3 to 5 year period following day 0)
Query!
Secondary outcome [15]
0
0
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Query!
Assessment method [15]
0
0
Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects
Query!
Timepoint [15]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [16]
0
0
Number of Subjects With Any and Related Medically Attended Visits
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
From Month 0 to Month 8 post-vaccination
Query!
Secondary outcome [17]
0
0
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
Query!
Assessment method [17]
0
0
Incidence of PHN calculated using the mTVc during the entire study period in subjects = 50 YOA.
Query!
Timepoint [17]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [18]
0
0
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
Query!
Assessment method [18]
0
0
Occurrence of PHN during the entire study period in all subjects with confirmed HZ.
Query!
Timepoint [18]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [19]
0
0
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.
Query!
Assessment method [19]
0
0
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 .
Query!
Timepoint [19]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
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.
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
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
Query!
Assessment method [21]
0
0
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.
Query!
Timepoint [21]
0
0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Query!
Secondary outcome [22]
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, Grade 3 and Related Solicited General Symptoms
Query!
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.
Query!
Timepoint [22]
0
0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Query!
Secondary outcome [23]
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,Grade 3 and Related Unsolicited AEs in Subjects = 70 YOA
Query!
Assessment method [23]
0
0
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.
Query!
Timepoint [23]
0
0
Within 30 days (Days 0 - 29) after each vaccination
Query!
Secondary outcome [24]
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 SAEs
Query!
Assessment method [24]
0
0
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.
Query!
Timepoint [24]
0
0
From Month 0 to Month 14
Query!
Secondary outcome [25]
0
0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs
Query!
Assessment method [25]
0
0
Fatal SAEs during the entire study period in subjects = 70 YOA.
Query!
Timepoint [25]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
Secondary outcome [26]
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 pIMDs
Query!
Assessment method [26]
0
0
Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects = 70 YOA.
Query!
Timepoint [26]
0
0
During the entire study period (3 to 5 year period following Day 0)
Query!
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
Query!
Assessment method [27]
0
0
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.
Query!
Timepoint [27]
0
0
From Month 0 to Month 8 post-vaccination
Query!
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.
Query!
Minimum age
70
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/08/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
24/07/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
14819
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Glebe
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Maroubra
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Umina
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Westmead
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Wollongong
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Caboolture
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - Kippa Ring
Query!
Recruitment hospital [8]
0
0
GSK Investigational Site - Geelong
Query!
Recruitment hospital [9]
0
0
GSK Investigational Site - Ivanhoe
Query!
Recruitment postcode(s) [1]
0
0
2037 - Glebe
Query!
Recruitment postcode(s) [2]
0
0
2035 - Maroubra
Query!
Recruitment postcode(s) [3]
0
0
2257 - Umina
Query!
Recruitment postcode(s) [4]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [5]
0
0
2522 - Wollongong
Query!
Recruitment postcode(s) [6]
0
0
4510 - Caboolture
Query!
Recruitment postcode(s) [7]
0
0
4021 - Kippa Ring
Query!
Recruitment postcode(s) [8]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [9]
0
0
3079 - Ivanhoe
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Idaho
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Nevada
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
South Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Tennessee
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Texas
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Utah
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Virginia
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Washington
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Minas Gerais
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Paraná
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Rio Grande Do Sul
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Curitiba/PR
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
São Paulo
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
British Columbia
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Newfoundland and Labrador
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Nova Scotia
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Quebec
Query!
Country [29]
0
0
Czechia
Query!
State/province [29]
0
0
Brno
Query!
Country [30]
0
0
Czechia
Query!
State/province [30]
0
0
Ceske Budejovice
Query!
Country [31]
0
0
Czechia
Query!
State/province [31]
0
0
Hradec Kralove
Query!
Country [32]
0
0
Estonia
Query!
State/province [32]
0
0
Tallinn
Query!
Country [33]
0
0
Estonia
Query!
State/province [33]
0
0
Tartu
Query!
Country [34]
0
0
Finland
Query!
State/province [34]
0
0
Espoo
Query!
Country [35]
0
0
Finland
Query!
State/province [35]
0
0
Helsinki
Query!
Country [36]
0
0
Finland
Query!
State/province [36]
0
0
Jarvenpaa
Query!
Country [37]
0
0
Finland
Query!
State/province [37]
0
0
Kokkola
Query!
Country [38]
0
0
Finland
Query!
State/province [38]
0
0
Oulu
Query!
Country [39]
0
0
Finland
Query!
State/province [39]
0
0
Pori
Query!
Country [40]
0
0
Finland
Query!
State/province [40]
0
0
Seinajoki
Query!
Country [41]
0
0
Finland
Query!
State/province [41]
0
0
Tampere
Query!
Country [42]
0
0
Finland
Query!
State/province [42]
0
0
Turku
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Angers
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Cherbourg
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Château Gontier
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Clermont-Ferrand
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Laval
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Montrevault
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Muret
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Nantes
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Rosiers d'Egletons
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Saint Cyr Sur Loir
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Segré
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Soulaines sur Aubance
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Tours
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Baden-Wuerttemberg
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Bayern
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Brandenburg
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Hessen
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Niedersachsen
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Nordrhein-Westfalen
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Rheinland-Pfalz
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Sachsen-Anhalt
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Sachsen
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Schleswig-Holstein
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Berlin
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Hamburg
Query!
Country [68]
0
0
Hong Kong
Query!
State/province [68]
0
0
Kwun Tong
Query!
Country [69]
0
0
Hong Kong
Query!
State/province [69]
0
0
Shatin
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Abruzzo
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Lazio
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Liguria
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Lombardia
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Piemonte
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Sardegna
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Sicilia
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Fukuoka
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Kanagawa
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Kyoto
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Tokyo
Query!
Country [81]
0
0
Korea, Republic of
Query!
State/province [81]
0
0
Ansan
Query!
Country [82]
0
0
Korea, Republic of
Query!
State/province [82]
0
0
Bucheon-si,
Query!
Country [83]
0
0
Korea, Republic of
Query!
State/province [83]
0
0
Incheon
Query!
Country [84]
0
0
Korea, Republic of
Query!
State/province [84]
0
0
Kangnam-gu, Seoul
Query!
Country [85]
0
0
Korea, Republic of
Query!
State/province [85]
0
0
Kangwon-do
Query!
Country [86]
0
0
Korea, Republic of
Query!
State/province [86]
0
0
Seoul
Query!
Country [87]
0
0
Mexico
Query!
State/province [87]
0
0
Jalisco
Query!
Country [88]
0
0
Mexico
Query!
State/province [88]
0
0
Morelos
Query!
Country [89]
0
0
Mexico
Query!
State/province [89]
0
0
Durango
Query!
Country [90]
0
0
Mexico
Query!
State/province [90]
0
0
Monterrey
Query!
Country [91]
0
0
Spain
Query!
State/province [91]
0
0
Alcover( Tarragona)
Query!
Country [92]
0
0
Spain
Query!
State/province [92]
0
0
Balenyà (Barcelona)
Query!
Country [93]
0
0
Spain
Query!
State/province [93]
0
0
Barcelona
Query!
Country [94]
0
0
Spain
Query!
State/province [94]
0
0
Centelles
Query!
Country [95]
0
0
Spain
Query!
State/province [95]
0
0
La Roca Del Valles (Barcelona)
Query!
Country [96]
0
0
Spain
Query!
State/province [96]
0
0
Madrid
Query!
Country [97]
0
0
Spain
Query!
State/province [97]
0
0
Majadahonda
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Peralada( Girona)
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Valencia
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Vic/ Barcelona
Query!
Country [101]
0
0
Sweden
Query!
State/province [101]
0
0
Borås
Query!
Country [102]
0
0
Sweden
Query!
State/province [102]
0
0
Eskilstuna
Query!
Country [103]
0
0
Sweden
Query!
State/province [103]
0
0
Göteborg
Query!
Country [104]
0
0
Sweden
Query!
State/province [104]
0
0
Jönköping
Query!
Country [105]
0
0
Sweden
Query!
State/province [105]
0
0
Karlskrona
Query!
Country [106]
0
0
Sweden
Query!
State/province [106]
0
0
Linköping
Query!
Country [107]
0
0
Sweden
Query!
State/province [107]
0
0
Malmö
Query!
Country [108]
0
0
Sweden
Query!
State/province [108]
0
0
Skövde
Query!
Country [109]
0
0
Sweden
Query!
State/province [109]
0
0
Stockholm
Query!
Country [110]
0
0
Sweden
Query!
State/province [110]
0
0
Uppsala
Query!
Country [111]
0
0
Sweden
Query!
State/province [111]
0
0
Vällingby
Query!
Country [112]
0
0
Sweden
Query!
State/province [112]
0
0
Örebro
Query!
Country [113]
0
0
Taiwan
Query!
State/province [113]
0
0
Taichung
Query!
Country [114]
0
0
Taiwan
Query!
State/province [114]
0
0
Taipei
Query!
Country [115]
0
0
Taiwan
Query!
State/province [115]
0
0
Taoyuan
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Lancashire
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Warwickshire
Query!
Country [118]
0
0
United Kingdom
Query!
State/province [118]
0
0
Wiltshire
Query!
Country [119]
0
0
United Kingdom
Query!
State/province [119]
0
0
Bangor
Query!
Country [120]
0
0
United Kingdom
Query!
State/province [120]
0
0
Belfast
Query!
Country [121]
0
0
United Kingdom
Query!
State/province [121]
0
0
Broughshane
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
Ledbury
Query!
Country [123]
0
0
United Kingdom
Query!
State/province [123]
0
0
Newtonabbey
Query!
Country [124]
0
0
United Kingdom
Query!
State/province [124]
0
0
Waterloo, Liverpool
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01165229
Query!
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. Kim JH, Diaz-Decaro J, Jiang N, Hwang SJ, Choo EJ, Co M, Hastie A, Hui DSC, Irimajiri J, Lee J, Leung EM, Tang H, Tsuru T, Watson P, Wu Z, Yu CJ, Yuan Y, Zahaf T, Cunningham AL, Schuind A. The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults >/= 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials. Hum Vaccin Immunother. 2021 Jul 3;17(7):2050-2057. doi: 10.1080/21645515.2020.1859321. Epub 2021 Feb 19. Dagnew AF, Rausch D, Herve C, Zahaf T, Levin MJ, Schuind A; ZOE-50/70 study group. Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials. Rheumatology (Oxford). 2021 Mar 2;60(3):1226-1233. doi: 10.1093/rheumatology/keaa424. Colindres R, Wascotte V, Brecx A, Clarke C, Herve C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, Cunningham AL. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29. Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, Schuind A; ZOE 50/70 study groups. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16. Lopez-Fauqued M, Campora L, Delannois F, El Idrissi M, Oostvogels L, De Looze FJ, Diez-Domingo J, Heineman TC, Lal H, McElhaney JE, McNeil SA, Yeo W, Tavares-Da-Silva F; ZOE-50/70 Study Group. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. Vaccine. 2019 Apr 24;37(18):2482-2493. doi: 10.1016/j.vaccine.2019.03.043. Epub 2019 Mar 29. Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, Berglund J, Campora L, de Looze F, Korhonen T, Leung E, Levin M, Volpi A, Johnson RW; ZOE-50/70 Study Group. Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238. doi: 10.1093/gerona/gly150.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Query!
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01165229