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

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

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.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster; Herpes Zoster Vaccine
• Intervention / Treatment: Biological: Herpes Zoster Vaccine GSK1437173A; Biological: Placebo

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: Interventional
• Enrollment (Actual): 14819
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Glebe, New South Wales, Australia, 2037
      • GSK Investigational Site
    • Maroubra, New South Wales, Australia, 2035
      • GSK Investigational Site
    • Umina, New South Wales, Australia, 2257
      • GSK Investigational Site
    • Westmead, New South Wales, Australia, 2145
      • GSK Investigational Site
    • Wollongong, New South Wales, Australia, 2522
      • GSK Investigational Site
  • Queensland
    • Caboolture, Queensland, Australia, 4510
      • GSK Investigational Site
    • Kippa Ring, Queensland, Australia, 4021
      • GSK Investigational Site
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • GSK Investigational Site
    • Ivanhoe, Victoria, Australia, 3079
      • GSK Investigational Site
• Brazil
  • Curitiba/PR, Brazil, 80240-280
    • GSK Investigational Site
  • São Paulo, Brazil, 04266-010
    • GSK Investigational Site
  • São Paulo, Brazil, 04312903
    • GSK Investigational Site
  • São Paulo, Brazil, 04038 002
    • GSK Investigational Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • GSK Investigational Site
  • Paraná
    • Curitiba/Paraná, Paraná, Brazil, 80810-050
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
      • GSK Investigational Site
• Canada
  • Quebec, Canada, G1W 4R4
    • GSK Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • GSK Investigational Site
    • Victoria, British Columbia, Canada, V8V 3P9
      • GSK Investigational Site
  • Newfoundland and Labrador
    • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
      • GSK Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • GSK Investigational Site
    • Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site
  • Ontario
    • Toronto, Ontario, Canada, M9W 4L6
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M4S 1Y2
      • GSK Investigational Site
    • Woodstock, Ontario, Canada, N4S 5P5
      • GSK Investigational Site
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 6S8
      • GSK Investigational Site
    • Mirabel, Quebec, Canada, J7J 2K8
      • GSK Investigational Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • GSK Investigational Site
    • Quebec City, Quebec, Canada, G1E 7G9
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 2G2
      • GSK Investigational Site
    • Trois Rivières, Quebec, Canada, G8T 7A1
      • GSK Investigational Site
• Czechia
  • Brno, Czechia, 662 10
    • GSK Investigational Site
  • Ceske Budejovice, Czechia, 370 04
    • GSK Investigational Site
  • Hradec Kralove, Czechia, 500 01
    • GSK Investigational Site
• Estonia
  • Tallinn, Estonia, 13619
    • GSK Investigational Site
  • Tartu, Estonia, 50106
    • GSK Investigational Site
• Finland
  • Espoo, Finland, 02230
    • GSK Investigational Site
  • Helsinki, Finland, 00100
    • GSK Investigational Site
  • Helsinki, Finland, 00930
    • GSK Investigational Site
  • Jarvenpaa, Finland, 04400
    • GSK Investigational Site
  • Kokkola, Finland, 67100
    • GSK Investigational Site
  • Oulu, Finland, 90220
    • GSK Investigational Site
  • Pori, Finland, 28100
    • GSK Investigational Site
  • Seinajoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• France
  • Angers, France, 49000
    • GSK Investigational Site
  • Cherbourg, France, 50100
    • GSK Investigational Site
  • Château Gontier, France, 53200
    • GSK Investigational Site
  • Clermont-Ferrand, France, 63003
    • GSK Investigational Site
  • Laval, France, 53000
    • GSK Investigational Site
  • Laval, France, 53100
    • GSK Investigational Site
  • Montrevault, France, 49110
    • GSK Investigational Site
  • Muret, France, 31600
    • GSK Investigational Site
  • Nantes, France, 44300
    • GSK Investigational Site
  • Rosiers d'Egletons, France, 19300
    • GSK Investigational Site
  • Saint Cyr Sur Loir, France, 37540
    • GSK Investigational Site
  • Segré, France, 49500
    • GSK Investigational Site
  • Soulaines sur Aubance, France, 49610
    • GSK Investigational Site
  • Tours, France, 37100
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10717
    • GSK Investigational Site
  • Berlin, Germany, 10629
    • GSK Investigational Site
  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Berlin, Germany, 13347
    • GSK Investigational Site
  • Berlin, Germany, 12351
    • GSK Investigational Site
  • Berlin, Germany, 12157
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Hamburg, Germany, 22415
    • GSK Investigational Site
  • Hamburg, Germany, 20251
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Deggingen, Baden-Wuerttemberg, Germany, 73326
      • GSK Investigational Site
    • Gueglingen, Baden-Wuerttemberg, Germany, 74363
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68161
      • GSK Investigational Site
    • Tuebingen, Baden-Wuerttemberg, Germany, 72074
      • GSK Investigational Site
    • Wangen, Baden-Wuerttemberg, Germany, 88239
      • GSK Investigational Site
    • Weinheim, Baden-Wuerttemberg, Germany, 69469
      • GSK Investigational Site
  • Bayern
    • Dachau, Bayern, Germany, 85221
      • GSK Investigational Site
    • Kuenzing, Bayern, Germany, 94550
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80339
      • GSK Investigational Site
    • Rednitzhembach, Bayern, Germany, 91126
      • GSK Investigational Site
    • Wallerfing, Bayern, Germany, 94574
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14467
      • GSK Investigational Site
  • Hessen
    • Floersheim, Hessen, Germany, 65439
      • GSK Investigational Site
    • Frankfurt, Hessen, Germany, 60389
      • GSK Investigational Site
  • Niedersachsen
    • Duelmen, Niedersachsen, Germany, 48249
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45355
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45359
      • GSK Investigational Site
    • Goch, Nordrhein-Westfalen, Germany, 47574
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 51069
      • GSK Investigational Site
    • Witten, Nordrhein-Westfalen, Germany, 58455
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site
    • Rhaunen, Rheinland-Pfalz, Germany, 55624
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01097
      • GSK Investigational Site
    • Freiberg, Sachsen, Germany, 09599
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04315
      • GSK Investigational Site
    • Pirna, Sachsen, Germany, 01796
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Koethen, Sachsen-Anhalt, Germany, 06366
      • GSK Investigational Site
    • Magdeburg, Sachsen-Anhalt, Germany, 39112
      • GSK Investigational Site
  • Schleswig-Holstein
    • Luebeck, Schleswig-Holstein, Germany, 23554
      • GSK Investigational Site
• Hong Kong
  • Kwun Tong, Hong Kong
    • GSK Investigational Site
  • Shatin, Hong Kong
    • GSK Investigational Site
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66013
      • GSK Investigational Site
    • Pescara, Abruzzo, Italy, 65100
      • GSK Investigational Site
  • Lazio
    • Roma, Lazio, Italy, 00163
      • GSK Investigational Site
  • Liguria
    • Genova, Liguria, Italy, 16132
      • GSK Investigational Site
  • Lombardia
    • Monza, Lombardia, Italy, 20052
      • GSK Investigational Site
  • Piemonte
    • Cuneo, Piemonte, Italy, 12100
      • GSK Investigational Site
  • Sardegna
    • Cagliari, Sardegna, Italy, 09127
      • GSK Investigational Site
    • Sassari, Sardegna, Italy, 07100
      • GSK Investigational Site
  • Sicilia
    • Catania, Sicilia, Italy, 95129
      • GSK Investigational Site
    • Ragusa (RG), Sicilia, Italy, 97100
      • GSK Investigational Site
• Japan
  • Fukuoka, Japan, 812-0025
    • GSK Investigational Site
  • Fukuoka, Japan, 810-0021
    • GSK Investigational Site
  • Fukuoka, Japan, 813-8588
    • GSK Investigational Site
  • Fukuoka, Japan, 816-0864
    • GSK Investigational Site
  • Kanagawa, Japan, 224-8503
    • GSK Investigational Site
  • Kanagawa, Japan, 247-8533
    • GSK Investigational Site
  • Kyoto, Japan, 611-0041
    • GSK Investigational Site
  • Tokyo, Japan, 142-8666
    • GSK Investigational Site
  • Tokyo, Japan, 154-0024
    • GSK Investigational Site
  • Tokyo, Japan, 141-0001
    • GSK Investigational Site
• Korea, Republic of
  • Ansan, Korea, Republic of, 425-707
    • GSK Investigational Site
  • Bucheon-si,, Korea, Republic of, 420-767
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 400-711
    • GSK Investigational Site
  • Kangnam-gu, Seoul, Korea, Republic of
    • GSK Investigational Site
  • Kangwon-do, Korea, Republic of, 220-701
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 152-703
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 150-950
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • GSK Investigational Site
• Mexico
  • Durango, Mexico, 34000
    • GSK Investigational Site
  • Monterrey, Mexico
    • GSK Investigational Site
  • Jalisco
    • Zapopan, Jalisco, Jalisco, Mexico, 45190
      • GSK Investigational Site
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62210
      • GSK Investigational Site
• Spain
  • Alcover( Tarragona), Spain, 43460
    • GSK Investigational Site
  • Balenyà (Barcelona), Spain, 08550
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Centelles, Spain
    • GSK Investigational Site
  • La Roca Del Valles (Barcelona), Spain, 08430
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Majadahonda, Spain
    • GSK Investigational Site
  • Peralada( Girona), Spain, 17491
    • GSK Investigational Site
  • Valencia, Spain, 46020
    • GSK Investigational Site
  • Vic/ Barcelona, Spain, 08500
    • GSK Investigational Site
• Sweden
  • Borås, Sweden, SE-506 30
    • GSK Investigational Site
  • Eskilstuna, Sweden, SE-631 88
    • GSK Investigational Site
  • Göteborg, Sweden, SE-413 45
    • GSK Investigational Site
  • Jönköping, Sweden, SE-551 85
    • GSK Investigational Site
  • Karlskrona, Sweden, SE-371 41
    • GSK Investigational Site
  • Linköping, Sweden, SE-58758
    • GSK Investigational Site
  • Malmö, Sweden, SE-211 52
    • GSK Investigational Site
  • Skövde, Sweden, SE-541 85
    • GSK Investigational Site
  • Stockholm, Sweden, SE-111 57
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
  • Vällingby, Sweden, SE-162 68
    • GSK Investigational Site
  • Örebro, Sweden, SE-703 62
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taipei, Taiwan, 112
    • GSK Investigational Site
  • Taipei, Taiwan
    • GSK Investigational Site
  • Taoyuan, Taiwan, 333
    • GSK Investigational Site
• United Kingdom
  • Bangor, United Kingdom, BT19 1PP
    • GSK Investigational Site
  • Belfast, United Kingdom, BT7 2EB
    • GSK Investigational Site
  • Broughshane, United Kingdom, BT42 4JP
    • GSK Investigational Site
  • Ledbury, United Kingdom, HR8 2AA
    • GSK Investigational Site
  • Newtonabbey, United Kingdom, BT37 9QW
    • GSK Investigational Site
  • Waterloo, Liverpool, United Kingdom, L22 0LG
    • GSK Investigational Site
  • Lancashire
    • Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
      • GSK Investigational Site
  • Warwickshire
    • Atherstone, Warwickshire, United Kingdom, CV9 1EU
      • GSK Investigational Site
  • Wiltshire
    • Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
      • GSK Investigational Site
• United States
  • Arizona
    • Mesa, Arizona, United States, 85213
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85020
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85050
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85018
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85704
      • GSK Investigational Site
  • California
    • Spring Valley, California, United States, 91978
      • GSK Investigational Site
    • Vista, California, United States, 92083
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33761
      • GSK Investigational Site
    • DeLand, Florida, United States, 32720
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32216
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32205
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • GSK Investigational Site
  • Idaho
    • Meridian, Idaho, United States, 83642
      • GSK Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • GSK Investigational Site
    • Columbia, Maryland, United States, 21045
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • GSK Investigational Site
    • Las Vegas, Nevada, United States, 89104
      • GSK Investigational Site
  • New Jersey
    • Edison, New Jersey, United States, 08817
      • GSK Investigational Site
    • Somers Point, New Jersey, United States, 08244
      • GSK Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28209
      • GSK Investigational Site
    • Hickory, North Carolina, United States, 28602
      • GSK Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • GSK Investigational Site
    • Wadsworth, Ohio, United States, 44281
      • GSK Investigational Site
  • Pennsylvania
    • Carnegie, Pennsylvania, United States, 15106
      • GSK Investigational Site
    • Pleasant Hills, Pennsylvania, United States, 15236
      • GSK Investigational Site
    • Uniontown, Pennsylvania, United States, 15401
      • GSK Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • GSK Investigational Site
    • Mount Pleasant, South Carolina, United States, 29464
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
  • Utah
    • Murray, Utah, United States, 84123
      • GSK Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22203
      • GSK Investigational Site
    • Norfolk, Virginia, United States, 23502
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23294
      • GSK Investigational Site
    • Winchester, Virginia, United States, 22601
      • GSK Investigational Site
  • Washington
    • Renton, Washington, United States, 98057
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo group; Subjects will receive NaCl solution placebo according to a 0, 2-month schedule	Biological: Placebo; Intramuscular injection.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Any Episodes of Herpes Zoster (HZ)	Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).	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)	Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).	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	Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.	During the entire study period (3 to 5 year period following Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Post-herpetic Neuralgia (PHN)	PHN cases in the mTVc.	During the entire study period (3 to 5 year period following Day 0)
Number of Days With Severe 'Worst' HZ-associated Pain	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.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations	The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Overall Mortality and HZ-related Mortality	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.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Confirmed HZ Episode Related Hospitalizations	Incidence of overall and HZ-related hospitalizations during the study.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With HZ Related Complications	Incidence of HZ complications during the study in subjects with confirmed HZ.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects Receiving Pain Medication Associated With HZ	Incidence of use of pain medications throughout the study	During the entire study period (3 to 5 year period following Day 0)
Number of Days With Pain Medication Associated With HZ	Incidence of reduction of duration of pain medication associated with HZ throughout the study.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	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.	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	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.	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)	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.	Within the 30 days (Days 0-29) after each vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs)	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.	From Month 0 to Month 14
Number of Subjects With Fatal Serious Adverse Events (SAEs)	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.	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	The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated	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)	Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Any and Related Medically Attended Visits	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.	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	Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.	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	Occurrence of PHN during the entire study period in all subjects with confirmed HZ.	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.	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 .	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.	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.	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	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.	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	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.	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	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.	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	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.	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	Fatal SAEs during the entire study period in subjects ≥ 70 YOA.	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	Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.	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	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.	From Month 0 to Month 8 post-vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• IPD for this study will be made available via the Clinical Study Data Request site.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2010
• Primary Completion (ACTUAL): July 24, 2015
• Study Completion (ACTUAL): July 24, 2015

Study Registration Dates

• First Submitted: July 15, 2010
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (ESTIMATE): July 19, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Vaccine; Adults; Immunogenicity; Herpes Zoster; Subjects 70 years and older
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex
• Other Study ID Numbers: 113077; 2009-015791-94 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR