Last updated: 03/16/2021 13:40:05

Cross-vaccination study of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies.

GSK study ID
204486
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Cross-vaccination study of GSK Biologicals’ Lyophilized formulation of the Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies
Trial description: The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects with Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Timeframe: During 30 days (Days 0-29) after any vaccination (across doses)

Number of subjects with Any and Related Serious Adverse Events (SAEs)

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Number of subjects with Any and Related Potential Immune Mediated Diseases (pIMDs)

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Secondary outcomes:

Number of subjects with at least one suspected Herpes Zoster (HZ) case(s)

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Interventions:
Biological/vaccine: Herpes Zoster Vaccine GSK1437173A
Enrollment:
8687
Observational study model:
Not applicable
Primary completion date:
2019-15-03
Time perspective:
Not applicable
Clinical publications:
Josephine Ocran-Appiah, Céline Boutry, Caroline Hervé, Jyoti Soni, Anne Schuind on behalf of the Z-056 Study Group. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label Study in previous ZOE-50 and ZOE-70 placebo recipients. Vaccine. 2020. 39(1):6-10.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
March 2016 to March 2019
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, follow-up contacts). Or subjects' Legally Acceptable Representative(s) [LAR(s)]/caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, availability for follow-up contacts).
  • Written informed consent obtained from the subject/Legally Acceptable representative(s) [LAR(s)] of the subject prior to performing any study specific procedure. If the subjects is not capable of giving consent, his/her assent to participate should be obtained to the extent possible.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use up to 30 days post Dose 2.
  • Previous vaccination against Varicella Zoster virus (VZV) or HZ.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Alcover( Tarragona), Spain, 43460
Status
Study Complete
Location
GSK Investigational Site
Angers, France, 49000
Status
Study Complete
Location
GSK Investigational Site
Angers, France, 49100
Status
Study Complete
Location
GSK Investigational Site
Ansan, South Korea, 425-707
Status
Study Complete
Location
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU
Status
Study Complete
Location
GSK Investigational Site
BORÅS, Sweden, SE-506 30
Status
Study Complete
Location
GSK Investigational Site
Balenyà (Barcelona), Spain, 08550
Status
Study Complete
Location
GSK Investigational Site
Bangor, United Kingdom, BT19 1NB
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08025
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08035
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Status
Study Complete
Location
GSK Investigational Site
Belfast, United Kingdom, BT7 2EB
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10629
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10717
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10787
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13347
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
Brno, Czech Republic, 662 10
Status
Study Complete
Location
GSK Investigational Site
Broughshane, United Kingdom, BT42 4JP
Status
Study Complete
Location
GSK Investigational Site
Bucheon-si,, South Korea, 420-767
Status
Study Complete
Location
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
Status
Study Complete
Location
GSK Investigational Site
Cary, North Carolina, United States, 27518
Status
Study Complete
Location
GSK Investigational Site
Centelles (Barcelona), Spain, 08540
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
Chieti, Abruzzo, Italy, 66013
Status
Study Complete
Location
GSK Investigational Site
Château Gontier, France, 53200
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Clermont-Ferrand, France, 63003
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44122
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21045
Status
Study Complete
Location
GSK Investigational Site
Cuneo, Piemonte, Italy, 12100
Status
Study Complete
Location
GSK Investigational Site
Curitiba, Paraná, Brazil, 80810-050
Status
Study Complete
Location
GSK Investigational Site
Curitiba/PR, Brazil, 80240-280
Status
Study Complete
Location
GSK Investigational Site
Dachau, Bayern, Germany, 85221
Status
Study Complete
Location
GSK Investigational Site
DeLand, Florida, United States, 32720
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
Status
Study Complete
Location
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
Status
Study Complete
Location
GSK Investigational Site
Durango, Durango, Mexico, 34000
Status
Study Complete
Location
GSK Investigational Site
ESKILSTUNA, Sweden, SE-631 88
Status
Study Complete
Location
GSK Investigational Site
Elkridge, Maryland, United States, 21075
Status
Study Complete
Location
GSK Investigational Site
Espoo, Finland, 02230
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
Floersheim, Hessen, Germany, 65439
Status
Study Complete
Location
GSK Investigational Site
Freiberg, Sachsen, Germany, 09599
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 810-0021
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 812-0025
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 813-8588
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 816-0864
Status
Study Complete
Location
GSK Investigational Site
Gatineau, Québec, Canada, J8Y 6S8
Status
Study Complete
Location
GSK Investigational Site
Geelong, Victoria, Australia, 3220
Status
Study Complete
Location
GSK Investigational Site
Genova, Liguria, Italy, 16132
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
GÖTEBORG, Sweden, SE-413 45
Status
Study Complete
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20246
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22143
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22415
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00100
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00930
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic
Status
Study Complete
Location
GSK Investigational Site
Incheon, South Korea, 400-711
Status
Study Complete
Location
GSK Investigational Site
Ivanhoe, Victoria, Australia, 3079
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
Jarvenpaa, Finland, 04400
Status
Study Complete
Location
GSK Investigational Site
Jojutla, Morelos, Mexico, 62900
Status
Study Complete
Location
GSK Investigational Site
JÖNKÖPING, Sweden, SE-551 85
Status
Study Complete
Location
GSK Investigational Site
KARLSKRONA, Sweden, SE-371 41
Status
Study Complete
Location
GSK Investigational Site
Kanagawa, Japan, 224-8503
Status
Study Complete
Location
GSK Investigational Site
Kanagawa, Japan, 247-8533
Status
Study Complete
Location
GSK Investigational Site
Kangnam-gu, Seoul, South Korea
Status
Study Complete
Location
GSK Investigational Site
Kangwon-do, South Korea, 220-701
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
Kokkola, Finland, 67100
Status
Study Complete
Location
GSK Investigational Site
Kuenzing, Bayern, Germany, 94550
Status
Study Complete
Location
GSK Investigational Site
Kwun Tong, Hong Kong
Status
Study Complete
Location
GSK Investigational Site
LINKÖPING, Sweden, SE-581 85
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
Laval, France, 53000
Status
Study Complete
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04315
Status
Study Complete
Location
GSK Investigational Site
Liverpool, United Kingdom, L22 0LG
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23554
Status
Study Complete
Location
GSK Investigational Site
MALMÖ, Sweden, SE-211 52
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28040
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28046
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Germany, 39120
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Majadahonda( Madrid, Spain, 28222
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
Meridian, Idaho, United States, 83642
Status
Study Complete
Location
GSK Investigational Site
Mesa, Arizona, United States, 85213
Status
Study Complete
Location
GSK Investigational Site
Mirabel, Québec, Canada, J7J 2K8
Status
Study Complete
Location
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64710
Status
Study Complete
Location
GSK Investigational Site
Montrevault, France, 49110
Status
Study Complete
Location
GSK Investigational Site
Monza, Lombardia, Italy, 20900
Status
Study Complete
Location
GSK Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80339
Status
Study Complete
Location
GSK Investigational Site
Muret, France, 31600
Status
Study Complete
Location
GSK Investigational Site
Murray, Utah, United States, 84123
Status
Study Complete
Location
GSK Investigational Site
Murs-Erigne, France, 49610
Status
Study Complete
Location
GSK Investigational Site
Nantes, France, 44300
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Newtonabbey, United Kingdom, BT37 9QW
Status
Study Complete
Location
GSK Investigational Site
Oulu, Finland, 90220
Status
Study Complete
Location
GSK Investigational Site
Pescara, Abruzzo, Italy, 65100
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
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Pori, Finland, 28100
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
Status
Study Complete
Location
GSK Investigational Site
Quebec, Québec, Canada, G1W 4R4
Status
Study Complete
Location
GSK Investigational Site
Québec City, Québec, Canada, G1E 7G9
Status
Study Complete
Location
GSK Investigational Site
Ragusa (RG), Sicilia, Italy, 97100
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
Roma, Lazio, Italy, 00163
Status
Study Complete
Location
GSK Investigational Site
Rosiers d'Egletons, France, 19300
Status
Study Complete
Location
GSK Investigational Site
SKÖVDE, Sweden, SE-541 50
Status
Study Complete
Location
GSK Investigational Site
Saint Cyr sur Loire, France, 37540
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
Sassari, Sardegna, Italy, 07100
Status
Study Complete
Location
GSK Investigational Site
Segré, France, 49500
Status
Study Complete
Location
GSK Investigational Site
Seinajoki, Finland, 60100
Status
Study Complete
Location
GSK Investigational Site
Seoul, South Korea, 135-710
Status
Study Complete
Location
GSK Investigational Site
Shatin, Hong Kong
Status
Study Complete
Location
GSK Investigational Site
Sherbrooke, Québec, Canada, J1H 2G2
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
Stockholm, Sweden, 11446
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04023-900
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, 05403-000
Status
Study Complete
Location
GSK Investigational Site
Taichung, Taiwan, 40447
Status
Study Complete
Location
GSK Investigational Site
Taipei, Taiwan
Status
Study Complete
Location
GSK Investigational Site
Tallinn, Estonia
Status
Study Complete
Location
GSK Investigational Site
Tampere, Finland, 33100
Status
Study Complete
Location
GSK Investigational Site
Taoyuan, Taiwan, 333
Status
Study Complete
Location
GSK Investigational Site
Tartu, Estonia, 50106
Status
Study Complete
Location
GSK Investigational Site
Tokyo, Japan, 142-0054
Status
Study Complete
Location
GSK Investigational Site
Tokyo, Japan, 142-8666
Status
Study Complete
Location
GSK Investigational Site
Tokyo, Japan, 154-0024
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4S 1Y2
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Status
Study Complete
Location
GSK Investigational Site
Tours, France, 37100
Status
Study Complete
Location
GSK Investigational Site
Trois-Rivieres, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85712
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72074
Status
Study Complete
Location
GSK Investigational Site
Turku, Finland, 20520
Status
Study Complete
Location
GSK Investigational Site
UPPSALA, Sweden, SE-751 85
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
Valencia, Spain, 46020
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Vic, Spain, 28500
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3M9
Status
Study Complete
Location
GSK Investigational Site
VÄLLINGBY, Sweden, SE-162 68
Status
Study Complete
Location
GSK Investigational Site
Wallerfing, Bayern, Germany, 94574
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
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
Wichita, Kansas, United States, 67207
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
Woodstock, Ontario, Canada, N4S 5P5
Status
Study Complete
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete
Location
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
Status
Study Complete
Location
GSK Investigational Site
peralada( Girona), Spain, 17491
Status
Study Complete
Location
GSK Investigational Site
ÖREBRO, Sweden, SE-703 62
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
Completed
Actual primary completion date
2019-15-03
Actual study completion date
2019-15-03

Plain language summaries

Summary of results in plain language
Available language(s): English, Czech, German, Spanish (Mexico), Spanish, Estonian, Finnish, French (Canadian), French, Italian, Japanese, Korean, Portuguese, Russian, Swedish (Finland), Swedish, Chinese (Hong Kong), Chinese (Taiwan)

To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website