Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older
NCT ID: NCT01165177
Last Updated: 2021-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
16165 participants
INTERVENTIONAL
2010-08-02
2015-07-27
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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GSK1437173A group
Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule
Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Placebo group
Subjects will receive NaCl solution placebo according to a 0, 2-month schedule
Placebo
Intramuscular injection
Interventions
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Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Placebo
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
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Spring Valley, California, United States
GSK Investigational Site
Vista, California, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
DeLand, Florida, United States
GSK Investigational Site
Jacksonville, Florida, United States
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Jacksonville, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
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Meridian, Idaho, United States
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Overland Park, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Kansas City, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Edison, New Jersey, United States
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Somers Point, New Jersey, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Wadsworth, Ohio, United States
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Carnegie, Pennsylvania, United States
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Pleasant Hills, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Bristol, Tennessee, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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Arlington, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Winchester, Virginia, United States
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Renton, Washington, United States
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Glebe, New South Wales, Australia
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Maroubra, New South Wales, Australia
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Umina, New South Wales, Australia
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Westmead, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Sherwood, Queensland, Australia
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Geelong, Victoria, Australia
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Ivanhoe, Victoria, Australia
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba/Paraná, Paraná, Brazil
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Curitiba/Paraná, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Curitiba/PR, , Brazil
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Curitiba/PR, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Victoria, British Columbia, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
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Truro, Nova Scotia, Canada
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Truro, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Woodstock, Ontario, Canada
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Woodstock, Ontario, Canada
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Gatineau, Quebec, Canada
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Gatineau, Quebec, Canada
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Mirabel, Quebec, Canada
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Mirabel, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Brno, , Czechia
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České Budějovice, , Czechia
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Hradec Králové, , Czechia
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Tallinn, , Estonia
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Tartu, , Estonia
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Espoo, , Finland
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Helsinki, , Finland
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Helsinki, , Finland
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Järvenpää, , Finland
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Kokkola, , Finland
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Oulu, , Finland
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Pori, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Angers, , France
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Château-Gontier, , France
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Cherbourg, , France
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Clermont-Ferrand, , France
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Laval, , France
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Laval, , France
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Montrevault, , France
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Muret, , France
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Nantes, , France
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Rosiers-d'Égletons, , France
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Saint Cyr Sur Loir, , France
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Segré, , France
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Soulaines-sur-Aubance, , France
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Tours, , France
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Deggingen, Baden-Wurttemberg, Germany
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Güglingen, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Tübingen, Baden-Wurttemberg, Germany
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Wangen, Baden-Wurttemberg, Germany
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Weinheim, Baden-Wurttemberg, Germany
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Dachau, Bavaria, Germany
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Künzing, Bavaria, Germany
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Munich, Bavaria, Germany
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Rednitzhembach, Bavaria, Germany
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Wallerfing, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Potsdam, Brandenburg, Germany
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Flörsheim, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Duelmen, Lower Saxony, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Goch, North Rhine-Westphalia, Germany
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Witten, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Rhaunen, Rhineland-Palatinate, Germany
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Dresden, Saxony, Germany
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Freiberg, Saxony, Germany
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Leipzig, Saxony, Germany
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Pirna, Saxony, Germany
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Köthen, Saxony-Anhalt, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Lübeck, Schleswig-Holstein, Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Kwun Tong, , Hong Kong
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Shatin, , Hong Kong
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Chieti, Abruzzo, Italy
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Pescara, Abruzzo, Italy
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Rome, Lazio, Italy
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Rome, Lazio, Italy
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Genoa, Liguria, Italy
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Milan, Lombardy, Italy
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Monza, Lombardy, Italy
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Cuneo, Piedmont, Italy
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Cagliari, Sardinia, Italy
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Sassari, Sardinia, Italy
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Catania, Sicily, Italy
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Ragusa (RG), Sicily, Italy
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Zapopan, Jalisco, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico
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Durango, , Mexico
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Monterrey, , Mexico
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Ansan, , South Korea
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Ansan, , South Korea
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Bucheon-si, , South Korea
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Bucheon-si, , South Korea
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Incheon, , South Korea
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Incheon, , South Korea
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Kangnam-gu, Seoul, , South Korea
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Kangwon-do, , South Korea
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Kangwon-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Alcover( Tarragona), , Spain
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Balenyà (Barcelona), , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Centelles, , Spain
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La Roca Del Valles (Barcelona), , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Peralada( Girona), , Spain
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Valencia, , Spain
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Vic/ Barcelona, , Spain
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Borås, , Sweden
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Borås, , Sweden
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Eskilstuna, , Sweden
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Eskilstuna, , Sweden
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Jönköping, , Sweden
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Jönköping, , Sweden
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Karlskrona, , Sweden
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Karlskrona, , Sweden
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Linköping, , Sweden
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Linköping, , Sweden
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Malmo, , Sweden
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Malmo, , Sweden
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Örebro, , Sweden
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Örebro, , Sweden
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Skövde, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Uppsala, , Sweden
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Vällingby, , Sweden
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Vällingby, , Sweden
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Buckshaw Village, Chorley, Lancashire, United Kingdom
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Buckshaw Village, Chorley, Lancashire, United Kingdom
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Atherstone, Warwickshire, United Kingdom
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Atherstone, Warwickshire, United Kingdom
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Bradford-on-Avon, Wiltshire, United Kingdom
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Bradford-on-Avon, Wiltshire, United Kingdom
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Bangor, , United Kingdom
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Bangor, , United Kingdom
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Belfast, , United Kingdom
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Belfast, , United Kingdom
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Broughshane, , United Kingdom
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Broughshane, , United Kingdom
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Ledbury, , United Kingdom
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Ledbury, , United Kingdom
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Newtonabbey, , United Kingdom
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Newtonabbey, , United Kingdom
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Waterloo, Liverpool, , United Kingdom
GSK Investigational Site
Waterloo, Liverpool, , United Kingdom
Countries
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References
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Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC; ZOE-70 Study Group. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.
Cunningham AL, Heineman TC, Lal H, Godeaux O, Chlibek R, Hwang SJ, McElhaney JE, Vesikari T, Andrews C, Choi WS, Esen M, Ikematsu H, Choma MK, Pauksens K, Ravault S, Salaun B, Schwarz TF, Smetana J, Abeele CV, Van den Steen P, Vastiau I, Weckx LY, Levin MJ; ZOE-50/70 Study Group. Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.
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, Lal H, Cunningham AL, Levin MJ, Johnson RW, Campora L, Volpi A, Heineman TC; ZOE-50/70 Study Group. Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018 Mar 14;36(12):1537-1541. doi: 10.1016/j.vaccine.2018.02.029. Epub 2018 Feb 17.
Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barbera J, Vesikari T, Watanabe D, Weckx L, Zahaf T, Heineman TC; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087-96. doi: 10.1056/NEJMoa1501184. Epub 2015 Apr 28.
Matthews S, Curran D, Sabater Cabrera E, Boutry C, Lecrenier N, Cunningham AL, Schmader K. An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies. Clin J Pain. 2023 Aug 1;39(8):386-393. doi: 10.1097/AJP.0000000000001129.
Kim JH, Johnson R, Kovac M, Cunningham AL, Amakrane M, Sullivan KM, Dagnew AF, Curran D, Schuind A. Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials. Pain. 2023 Apr 1;164(4):741-748. doi: 10.1097/j.pain.0000000000002760. Epub 2022 Aug 19.
Carryn S, Cheuvart B, Povey M, Dagnew AF, Harpaz R, van der Most R, Casabona G. No Consistent Evidence of Decreased Exposure to Varicella-Zoster Virus Among Older Adults in Countries with Universal Varicella Vaccination. J Infect Dis. 2022 Feb 1;225(3):413-421. doi: 10.1093/infdis/jiab500.
Kim JH, Diaz-Decaro J, Jiang N, Hwang SJ, Choo EJ, Co M, Hastie A, Hui DSC, Irimajiri J, Lee J, Leung EM, Tang H, Tsuru T, Watson P, Wu Z, Yu CJ, Yuan Y, Zahaf T, Cunningham AL, Schuind A. The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults >/= 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials. Hum Vaccin Immunother. 2021 Jul 3;17(7):2050-2057. doi: 10.1080/21645515.2020.1859321. Epub 2021 Feb 19.
Dagnew AF, Rausch D, Herve C, Zahaf T, Levin MJ, Schuind A; ZOE-50/70 study group. Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials. Rheumatology (Oxford). 2021 Mar 2;60(3):1226-1233. doi: 10.1093/rheumatology/keaa424.
Colindres R, Wascotte V, Brecx A, Clarke C, Herve C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, Cunningham AL. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29.
Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, Schuind A; ZOE 50/70 study groups. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16.
Lopez-Fauqued M, Campora L, Delannois F, El Idrissi M, Oostvogels L, De Looze FJ, Diez-Domingo J, Heineman TC, Lal H, McElhaney JE, McNeil SA, Yeo W, Tavares-Da-Silva F; ZOE-50/70 Study Group. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. Vaccine. 2019 Apr 24;37(18):2482-2493. doi: 10.1016/j.vaccine.2019.03.043. Epub 2019 Mar 29.
Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, Berglund J, Campora L, de Looze F, Korhonen T, Leung E, Levin M, Volpi A, Johnson RW; ZOE-50/70 Study Group. Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238. doi: 10.1093/gerona/gly150.
Related Links
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IPD for this study will be made available via the Clinical Study Data Request site.
Other Identifiers
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2008-000367-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
110390
Identifier Type: -
Identifier Source: org_study_id
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