Clinical Trial: Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

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.


Detailed Summary:

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.


Sponsor: GlaxoSmithKline

Current Primary Outcome: 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)


Original Primary Outcome: Confirmed HZ cases [ Time Frame: 3 to 5 year period following Day 0 ]

Current Secondary Outcome:

  • 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 [defin

    Original Secondary Outcome:

    • Occurrence of medically attended visits [ Time Frame: From Month 0 to Month 8 ]
    • Occurrence of overall Postherpetic Neuralgia (PHN) [ Time Frame: 3 to 5 year period following Day 0 ]
    • Duration of severe 'worst' HZ-associated pain in subjects with confirmed HZ [ Time Frame: 3 to 5 year period following Day 0 ]
    • Incidence of overall and HZ-related mortality [ Time Frame: 3 to 5 year period following Day 0 ]
    • Incidence of HZ complications [ Time Frame: 3 to 5 year period following Day 0 ]
    • Incidence of overall and HZ-related hospitalizations [ Time Frame: 3 to 5 year period following Day 0 ]
    • Duration of pain medication administered for HZ [ Time Frame: 3 to 5 year period following Day 0 ]
    • Occurrence of solicited local and general symptoms in a subset of subjects [ Time Frame: 7 days (Days 0-6) after each vaccination ]
    • Occurrence of unsolicited adverse events (AEs) [ Time Frame: 30 days (Days 0-29) after each vaccination ]
    • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From Month 0 to Month 14 ]
    • Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine [ Time Frame: 3 to 5 year period following Day 0 ]
    • Occurrence of fatal SAEs [ Time Frame: 3 to 5 year period following Day 0 ]
    • Occurrence of pre-defined AEs [ Time Frame: 3 to 5 year period following Day 0 ]


    Information By: GlaxoSmithKline

    Dates:
    Date Received: July 15, 2010
    Date Started: August 2010
    Date Completion:
    Last Updated: March 21, 2017
    Last Verified: March 2017