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Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01165229
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 ≥ 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.


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, Care Provider, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with any episodes of herpes zoster (HZ) [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).

  • 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) [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with confirmed HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.


Secondary Outcome Measures:
  • Number of subjects with post-herpetic neuralgia (PHN) [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    PHN cases in the mTVc.

  • Number of days with severe 'worst' HZ-associated pain [ Time Frame: During the entire study period (3 to 5 year period following Day 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.

  • 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) ]
  • Number of subjects with overall mortality and HZ-related mortality [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Incidence of overall and HZ-related mortality during the study.

  • Number of subjects with confirmed HZ episode related hospitalizations [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Incidence of overall and HZ-related hospitalizations during the study.

  • Number of subjects with HZ related complications [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Incidence of HZ complications during the study in subjects with confirmed HZ.

  • Number of subjects receiving pain medication associated with HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
  • Number of days with pain medication associated with HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
  • Number of subjects with solicited local symptoms [ Time Frame: Within the 7 days (Days 0-6) after each vaccination ]
    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 = 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 solicited general symptoms [ Time Frame: Within the 7 days (Days 0-6) post-vaccination period ]
    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 = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of subjects with unsolicited adverse events (AEs) [ Time Frame: Within the 30 days (Days 0-29) after each vaccination ]
    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.

  • Number of subjects with any, related and fatal serious adverse events (SAEs) [ Time Frame: From Month 0 to Month 14 and until study end (3 to 5 year period following Day 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.

  • Number of subjects with 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) during the entire study period in all subjects

  • Number of subjects with Medically Attended events (MAEs) [ Time Frame: From Month 0 to Month 8 post-vaccination ]
    Occurrence and relationship to vaccination of medically attended visitsother than routine health care visits, from Month 0 to Month 8 in all subjects. MAEs 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 MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

  • 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 [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.

  • 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 [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Occurrence of PHN during the entire study period in all subjects with confirmed HZ.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with reduction of duration of severe 'worst' HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ. [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Number of subjects with reduction of 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 ≥ 70 YOA with confirmed HZ.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of days with severe 'worst' HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ. [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Reduction of 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 ≥ 70 YOA with confirmed HZ.

  • 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 [ Time Frame: Within 7 days (Days 0-6) after each vaccination ]
    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. Relationship analysis was not performed..

  • 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 [ Time Frame: Within 7 days (Days 0-6) after each vaccination ]
    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 = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with unsolicited AEs in subjects ≥ 70 YOA [ Time Frame: Within 30 days (Days 0 - 29) after each vaccination ]
    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.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any, related and fatal SAEs [ Time Frame: From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0) ]
    Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any pIMDs [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.

  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with Medically Attended events (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, from Month 0 to Month 8 in subjects ≥ 70 YOA.


Enrollment: 14819
Study Start Date: August 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.
  Eligibility

Ages Eligible for Study:   70 Years and older   (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 70 years or older at the time of the first vaccination.

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.
  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: NCT01165229

  Show 215 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: NCT01165229     History of Changes
Other Study ID Numbers: 113077
2009-015791-94 ( EudraCT Number )
Study First Received: July 15, 2010
Last Updated: March 21, 2017

Keywords provided by GlaxoSmithKline:
Immunogenicity
Subjects 70 years and older
Efficacy
Herpes Zoster
Safety
Adults
Vaccine

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 March 29, 2017