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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/NCT01165177
Registration number
NCT01165177
Ethics application status
Date submitted
15/07/2010
Date registered
19/07/2010
Date last updated
10/02/2021
Titles & IDs
Public title
Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older
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Scientific title
Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
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Secondary ID [1]
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2008-000367-42
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Secondary ID [2]
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110390
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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 GSK1437173A
Other interventions - Placebo
Experimental: GSK1437173A 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 Confirmed Herpes Zoster (HZ) Cases
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Assessment method [1]
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Confirmed HZ cases during the study were assessed 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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Secondary outcome [1]
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Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)
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Assessment method [1]
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The incidence of PHN was calculated using the modified total vaccinated chort.
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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 Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain
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Assessment method [2]
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Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the 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 ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.
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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
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Assessment method [3]
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The analysis focused on the number of subjects who died due to HZ
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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 HZ Related Complications
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Assessment method [4]
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The analysis focused on the incidence of HZ complications in subjects with confirmed HZ
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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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The analysis focused on confirmed HZ episode related hospitalizations.
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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 a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ
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Assessment method [6]
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The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ 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 With a Confirmed HZ Episode Taking Pain Medication Associated With HZ
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Assessment method [7]
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The analysis focused on subjects taking pain medication due to HZ
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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 Severe 'Worst' HZ-associated Pain.
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Assessment method [8]
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Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during 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 Confirmed HZ Episode Related Mortality and Hospitalizations
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Assessment method [9]
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The analysis focused on confirmed HZ episode related hospitalizations and deaths.
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Timepoint [9]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [10]
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Number of Subjects With HZ Related Complications, by Complication Type
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Assessment method [10]
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Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.
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Timepoint [10]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [11]
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Distribution of Pain Medication Associated With HZ
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Assessment method [11]
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The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ.
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Timepoint [11]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [12]
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Number of Days of Pain Medication Associated With HZ
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Assessment method [12]
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The analysis was performed on subjects with a confirmed HZ episode
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Timepoint [12]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [13]
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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Assessment method [13]
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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 = Significant pain at rest that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
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Timepoint [13]
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During the 7-day (Days 0-6) post-vaccination period
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Secondary outcome [14]
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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Assessment method [14]
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Assessed solicited general symptoms were fatigue, GI (gastrointestinal) symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. 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 [14]
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Within the 7-day (Days 0-6) post-vaccination period
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Secondary outcome [15]
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Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)
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Assessment method [15]
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Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated
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Timepoint [15]
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Within the 7-day (Days 0-6) post-vaccination period
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Secondary outcome [16]
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Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
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Assessment method [16]
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Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects
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Timepoint [16]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [17]
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Number of Subjects With AEs With Any and Related Medically Attended Visit
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Assessment method [17]
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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 in all subjects.
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Timepoint [17]
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From Month 0 to Month 8 post-vaccination
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Secondary outcome [18]
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Number of Subjects With Unsolicited Adverse Events (AEs)
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Assessment method [18]
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Occurrence, intensity and relationship to vaccination of unsolicited AEs, 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 [18]
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Within 30 days (Days 0 - 29) after each vaccination
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Secondary outcome [19]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [19]
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Occurrence and relationship to vaccination of all SAEs in all subjects. 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 [19]
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Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)
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Secondary outcome [20]
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Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
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Assessment method [20]
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The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated
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Timepoint [20]
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During the entire study period (3 to 5 year period following Day 0)
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Secondary outcome [21]
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Number of Subjects With Fatal SAEs
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Assessment method [21]
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Number of subjects with fatal SAEs during the entire study period were tabulated
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Timepoint [21]
0
0
During the entire study period (3 to 5 years following day 0)
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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 50 years or older at the time of the first vaccination;
- Female subjects of non-childbearing potential may be enrolled in the study;
For this study population, non-childbearing potential is defined as current tubal ligation,
hysterectomy, ovariectomy or post-menopause.
OR Female subjects of childbearing potential may be enrolled in the study, if the subject
has practiced adequate contraception for 30 days prior to vaccination, and has a negative
urine 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
50
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 enrollment;
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose.
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive
precautions.
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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 assessing the outcomes
The people analysing the results/data
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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
27/07/2015
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Sample size
Target
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Accrual to date
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Final
16165
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Glebe
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Recruitment hospital [2]
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GSK Investigational Site - Maroubra
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Recruitment hospital [3]
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GSK Investigational Site - Umina
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Recruitment hospital [4]
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GSK Investigational Site - Westmead
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Recruitment hospital [5]
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GSK Investigational Site - Wollongong
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Recruitment hospital [6]
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GSK Investigational Site - Sherwood
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Recruitment hospital [7]
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GSK Investigational Site - Geelong
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Recruitment hospital [8]
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GSK Investigational Site - Ivanhoe
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Recruitment postcode(s) [1]
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2037 - Glebe
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Recruitment postcode(s) [2]
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2035 - Maroubra
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Recruitment postcode(s) [3]
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2257 - Umina
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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2522 - Wollongong
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Recruitment postcode(s) [6]
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4075 - Sherwood
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Recruitment postcode(s) [7]
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3220 - Geelong
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Recruitment postcode(s) [8]
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3079 - Ivanhoe
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Recruitment outside Australia
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United States of America
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Arizona
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California
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United States of America
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Florida
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Idaho
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Kansas
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Maryland
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Missouri
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Nevada
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New Jersey
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North Carolina
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Ohio
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Rio Grande Do Sul
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Brazil
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Sachsen-Anhalt
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Sachsen
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Schleswig-Holstein
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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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Lazio
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Italy
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Liguria
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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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Sicilia
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Japan
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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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Korea, Republic of
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Bucheon-si,
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Incheon
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Kangwon-do
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Seoul
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Mexico
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Mexico
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Durango
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Mexico
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Centelles
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Spain
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La Roca Del Valles (Barcelona)
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Madrid
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Borås
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Stockholm
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Uppsala
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Vällingby
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Örebro
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Taichung
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Taipei
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Taoyuan
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United Kingdom
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Lancashire
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United Kingdom
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Warwickshire
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Wiltshire
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Bangor
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United Kingdom
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United Kingdom
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Ledbury
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United Kingdom
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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 = 50
years.
Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being 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. The
protocol posting of study ZOSTER-022 also deals with the outcome measures related to the
pooled analysis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01165177
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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.
Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barbera J, Vesikari T, Watanabe D, Weckx L, Zahaf T, Heineman TC; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087-96. doi: 10.1056/NEJMoa1501184. Epub 2015 Apr 28.
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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/NCT01165177
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