Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    NCT01165229
Previous Study | Return to List | Next Study

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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01165229
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : November 20, 2017
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 15, 2010
First Posted Date  ICMJE July 19, 2010
Results First Submitted Date  ICMJE May 9, 2017
Results First Posted Date  ICMJE November 20, 2017
Last Update Posted Date April 27, 2020
Actual Study Start Date  ICMJE August 2, 2010
Actual Primary Completion Date July 24, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of overall PHN in subjects >= 50 years of age (YOA) [ Time Frame: 3 to 5 year period following Day 0 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of confirmed HZ in subjects >= 70 YOA [ Time Frame: 3 to 5 year period following Day 0 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022:Occurrence of overall PHN in subjects >= 70 YOA [ Time Frame: 3 to 5 year period following Day 0 ]
  • Confirmed HZ cases [ Time Frame: 3 to 5 year period following Day 0 ]
  • Postherpetic Neuralgia (PHN) cases [ Time Frame: 3 to 5 year period following Day 0 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • 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) ]
    The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.
  • 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) ]
    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.
  • 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) ]
    Incidence of use of pain medications throughout the study
  • Number of Days With Pain Medication Associated With HZ [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Incidence of reduction of duration of pain medication associated with HZ throughout the study.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    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.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    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.
  • Number of Subjects With Any, Grade 3 and Related 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 and Related Serious Adverse Events (SAEs) [ Time Frame: From Month 0 to Month 14 ]
    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 Fatal Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (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 SAEs Related to Study Participation or Concomitant GSK Medication [ Time Frame: During the entire study period (3 to 5 year period following day 0) ]
    The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated
  • 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) during the entire study period in all subjects
  • Number of Subjects With Any and Related Medically Attended Visits [ Time Frame: From Month 0 to Month 8 post-vaccination ]
    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.
  • 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 at Least One Day 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) ]
    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 .
  • 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. [ 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 was 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 the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    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.
  • 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 the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    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.
  • 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 [ 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 and Related SAEs [ Time Frame: From Month 0 to Month 14 ]
    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.
  • Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Fatal SAEs 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 Any and Related 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 Any and Related Medically Attended Visits [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
  • 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 ]
  • Occurrence of medically attended visits [ Time Frame: From Month 0 to Month 8 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of PHN in subjects >= 50 YOA with confirmed HZ [ Time Frame: 3 to 5 year period following Day 0 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Duration of severe 'worst' HZ-associated pain in subjects >= 70 YOA with confirmed HZ [ Time Frame: 3 to 5 year period following Day 0 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of pre-defined AEs in subjects >= 70 YOA [ Time Frame: 3 to 5 year period following Day 0 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of medically attended visits in subjects >= 70 YOA [ Time Frame: From Month 0 to Month 8 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of solicited local and general symptoms in subjects >= 70 YOA included in a subset of subjects [ Time Frame: 7 days (Days 0-6) after each vaccination ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of unsolicited AEs in subjects >= 70 YOA [ Time Frame: 30 days (Days 0-29) after each vaccination ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of SAEs in subjects >= 70 YOA [ Time Frame: From Month 0 to Month 14 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine [ Time Frame: 3 to 5 year period following Day 0 ]
  • Outcome measure for the pooled analysis of combined data from studies Zoster-006 and Zoster-022: Occurrence of fatal SAEs [ Time Frame: 3 to 5 year period following Day 0 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
Official Title  ICMJE Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 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 ≥ 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Herpes Zoster
  • Herpes Zoster Vaccine
Intervention  ICMJE
  • Biological: Herpes Zoster Vaccine GSK1437173A
    Intramuscular injection
  • Biological: Placebo
    Intramuscular injection.
Study Arms  ICMJE
  • Experimental: Zoster vaccine group
    Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule
    Intervention: Biological: Herpes Zoster Vaccine GSK1437173A
  • Placebo Comparator: Placebo group
    Subjects will receive NaCl solution placebo according to a 0, 2-month schedule
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2016)
14819
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2010)
11000
Actual Study Completion Date  ICMJE July 24, 2015
Actual Primary Completion Date July 24, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Czechia,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Mexico,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01165229
Other Study ID Numbers  ICMJE 113077
2009-015791-94 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: 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.
URL: https://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP