Last updated: 07/18/2020 12:12:21
Study to evaluate efficacy, safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A in adults aged 70 years and older
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Efficacy, safety and immunogenicity study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged 70 years or older
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with any episodes of herpes zoster (HZ)
Timeframe: During the entire study period (3 to 5 year period following Day 0)
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)
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with confirmed HZ
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Secondary outcomes:
Number of subjects with post-herpetic neuralgia (PHN)
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of days with severe ‘worst’ HZ-associated pain
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with confirmed HZ episode related mortality and hospitalizations
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with overall mortality and HZ-related mortality
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with confirmed HZ episode related hospitalizations
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with HZ related complications
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects receiving pain medication associated with HZ
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of days with pain medication associated with HZ
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within the 30 days (Days 0-29) after each vaccination
Number of subjects with any and related serious adverse events (SAEs)
Timeframe: From Month 0 to Month 14
Number of subjects with fatal serious adverse events (SAEs)
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with SAEs related to study participation or concomitant GSK medication
Timeframe: During the entire study period (3 to 5 year period following day 0)
Number of subjects with any and related potential immune mediated diseases (pIMDs)
Timeframe: During the entire study period (3 to 5 year period following Day 0)
Number of subjects with any and related Medically attended visits
Timeframe: From Month 0 to Month 8 post-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
Timeframe: During the entire study period (3 to 5 year period following Day 0)
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
Timeframe: During the entire study period (3 to 5 year period following Day 0)
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.
Timeframe: During the entire study period (3 to 5 year period following Day 0)
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.
Timeframe: During the entire study period (3 to 5 year period following Day 0)
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
Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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
Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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
Timeframe: Within 30 days (Days 0 - 29) after each 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
Timeframe: From Month 0 to Month 14
Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with fatal SAEs
Timeframe: During the entire study period (3 to 5 year period following Day 0)
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
Timeframe: During the entire study period (3 to 5 year period following Day 0)
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
Timeframe: From Month 0 to Month 8 post-vaccination
Interventions:
Enrollment:
14819
Primary completion date:
2015-24-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cunningham AL et al. (2016) Efficacy of the Herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 375(11):1019-1032.
Cunningham AL et al. (2018) Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older.J Infect Dis. 217(11):1750-1760.
Cunningham AL et al. (2018) Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in adults aged 50 years or older. J Infect Dis. 217(11):1750-1760.
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 et al (2018) Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 36(12):1537-1541.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
August 2010 to July 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
70+ years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent obtained from the subject.
- A male or female aged 70 years or older at the time of the first vaccination.
Subjects who the investigator believes will comply with the requirements of the protocol.
Exclusion criteria:
- 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.
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.
Trial location(s)
Location
GSK Investigational Site
Arlington, Virginia, United States, 22203
Status
Study Complete
Location
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21209
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Status
Study Complete
Location
GSK Investigational Site
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
Status
Study Complete
Location
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Location
GSK Investigational Site
Cary, North Carolina, United States, 27518
Status
Study Complete
Location
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 04
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21045
Status
Study Complete
Location
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil, 80810-050
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08817
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45355
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Glebe, New South Wales, Australia, 2037
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29650
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28602
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64114
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Koethen, Sachsen-Anhalt, Germany, 06366
Status
Study Complete
Location
GSK Investigational Site
La Roca del Valles (Barcelona), Spain, 08430
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23554
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Maroubra, New South Wales, Australia, 2035
Status
Study Complete
Location
GSK Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23502
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66212
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85018
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85020
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Pleasant Hills, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
Status
Study Complete
Location
GSK Investigational Site
Rednitzhembach, Bayern, Germany, 91126
Status
Study Complete
Location
GSK Investigational Site
Renton, Washington, United States, 98057
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04038 002
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04266-010
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04312903
Status
Study Complete
Location
GSK Investigational Site
Trois Rivières, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Tucscon, Arizona, United States, 85704
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72074
Status
Study Complete
Location
GSK Investigational Site
Umina, New South Wales, Australia, 2257
Status
Study Complete
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3P9
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
Wandsworth, Ohio, United States, 44281
Status
Study Complete
Location
GSK Investigational Site
Wangen, Baden-Wuerttemberg, Germany, 88239
Status
Study Complete
Location
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0LG
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Winchester, Virginia, United States, 22601
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
Status
Study Complete
Location
GSK Investigational Site
Wollongong, New South Wales, Australia, 2522
Status
Study Complete
Location
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-24-07
Actual study completion date
2015-24-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
IPD for this study will be made available via the Clinical Study Data Request site.
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