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Trial record 1 of 19 for:    herpes zoster | GlaxosmithKline | Adult, Senior | Phase 3
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Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01165177
First received: July 15, 2010
Last updated: March 21, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention Phase
Herpes Zoster Biological: Herpes Zoster Vaccine GSK1437173A Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Confirmed Herpes Zoster (HZ) Cases [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)


Secondary Outcome Measures:
  • Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The incidence of PHN was calculated using the modified total vaccinated chort.

  • Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    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.

  • Number of Subjects With Confirmed HZ Episode Related Mortality [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The analysis focused on the number of subjects who died due to HZ

  • Number of Subjects With HZ Related Complications [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The analysis focused on the incidence of HZ complications in subjects with confirmed HZ

  • Number of Subjects With Confirmed HZ Episode Related Hospitalizations [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The analysis focused on confirmed HZ episode related hospitalizations.

  • Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.

  • Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The analysis focused on subjects taking pain medication due to HZ

  • Number of Days With Severe 'Worst' HZ-associated Pain. [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    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.

  • Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The analysis focused on confirmed HZ episode related hospitalizations and deaths.

  • Number of Subjects With HZ Related Complications, by Complication Type [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    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.

  • Distribution of Pain Medication Associated With HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed participants with confirmed HZ.

  • Number of Days of Pain Medication Associated With HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    The analysis was performed in subjects with a confirmed HZ episode

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    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. Relationship analysis was not performed.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, 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 = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period ]
  • Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects

  • Number of Subjects With AEs With Any and Related Medically Attended Visit (MAEs) [ Time Frame: From Month 0 to Month 8 post-vaccination ]
    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.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: Within 30 days (Days 0 - 29) after each vaccination ]
    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.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: 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) ]
    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.


Enrollment: 16165
Study Start Date: August 2010
Study Completion Date: July 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoster vaccine group
Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule
Biological: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Placebo Comparator: Placebo group
Subjects will receive NaCl solution placebo according to a 0, 2-month schedule
Biological: Placebo
Intramuscular injection

Detailed Description:

This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints and the analyses of the objectives in 2 steps.

Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA, and other pre-specified endpoints will be analyzed.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165177

  Show 213 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01165177     History of Changes
Other Study ID Numbers: 110390
2008-000367-42 ( EudraCT Number )
Study First Received: July 15, 2010
Results First Received: July 28, 2016
Last Updated: March 21, 2017

Keywords provided by GlaxoSmithKline:
subjects 50 years and older
vaccine
immunogenicity
efficacy
Herpes Zoster
safety

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 16, 2017