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
2 other identifiers
interventional
14,819
17 countries
201
Brief Summary
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2010
Longer than P75 for phase_3
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2010
CompletedFirst Posted
Study publicly available on registry
July 19, 2010
CompletedStudy Start
First participant enrolled
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2015
CompletedResults Posted
Study results publicly available
November 20, 2017
CompletedApril 27, 2020
April 1, 2020
5 years
July 15, 2010
May 9, 2017
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (27)
Number of Subjects With Post-herpetic Neuralgia (PHN)
During the entire study period (3 to 5 year period following Day 0)
Number of Days With Severe 'Worst' HZ-associated Pain
During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Overall Mortality and HZ-related Mortality
During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Confirmed HZ Episode Related Hospitalizations
During the entire study period (3 to 5 year period following Day 0)
- +22 more secondary outcomes
Study Arms (2)
Zoster vaccine group
EXPERIMENTALSubjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule
Placebo group
PLACEBO COMPARATORSubjects will receive NaCl solution placebo according to a 0, 2-month schedule
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (213)
GSK Investigational Site
Mesa, Arizona, 85213, United States
GSK Investigational Site
Phoenix, Arizona, 85018, United States
GSK Investigational Site
Phoenix, Arizona, 85020, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Tucson, Arizona, 85704, United States
GSK Investigational Site
Spring Valley, California, 91978, United States
GSK Investigational Site
Vista, California, 92083, United States
GSK Investigational Site
Clearwater, Florida, 33761, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
West Palm Beach, Florida, 33409, United States
GSK Investigational Site
Meridian, Idaho, 83642, United States
GSK Investigational Site
Overland Park, Kansas, 66212, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Baltimore, Maryland, 21209, United States
GSK Investigational Site
Columbia, Maryland, 21045, United States
GSK Investigational Site
Kansas City, Missouri, 64114, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Edison, New Jersey, 08817, United States
GSK Investigational Site
Somers Point, New Jersey, 08244, United States
GSK Investigational Site
Cary, North Carolina, 27518, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Hickory, North Carolina, 28602, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cleveland, Ohio, 44122, United States
GSK Investigational Site
Wadsworth, Ohio, 44281, United States
GSK Investigational Site
Carnegie, Pennsylvania, 15106, United States
GSK Investigational Site
Pleasant Hills, Pennsylvania, 15236, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, United States
GSK Investigational Site
Greer, South Carolina, 29650, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Murray, Utah, 84123, United States
GSK Investigational Site
Arlington, Virginia, 22203, United States
GSK Investigational Site
Norfolk, Virginia, 23502, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Winchester, Virginia, 22601, United States
GSK Investigational Site
Renton, Washington, 98057, United States
GSK Investigational Site
Glebe, New South Wales, 2037, Australia
GSK Investigational Site
Maroubra, New South Wales, 2035, Australia
GSK Investigational Site
Umina, New South Wales, 2257, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Wollongong, New South Wales, 2522, Australia
GSK Investigational Site
Caboolture, Queensland, 4510, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Geelong, Victoria, 3220, Australia
GSK Investigational Site
Ivanhoe, Victoria, 3079, Australia
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30150-221, Brazil
GSK Investigational Site
Curitiba/Paraná, Paraná, 80810-050, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035003, Brazil
GSK Investigational Site
Curitiba/PR, 80240-280, Brazil
GSK Investigational Site
São Paulo, 04038 002, Brazil
GSK Investigational Site
São Paulo, 04266-010, Brazil
GSK Investigational Site
São Paulo, 04312903, Brazil
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
GSK Investigational Site
Victoria, British Columbia, V8V 3P9, Canada
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Toronto, Ontario, M4S 1Y2, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Woodstock, Ontario, N4S 5P5, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Mirabel, Quebec, J7J 2K8, Canada
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
GSK Investigational Site
Québec, Quebec, G1E 7G9, Canada
GSK Investigational Site
Québec, Quebec, G1W 4R4, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 2G2, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Brno, 662 10, Czechia
GSK Investigational Site
České Budějovice, 370 04, Czechia
GSK Investigational Site
Hradec Králové, 500 01, Czechia
GSK Investigational Site
Tallinn, 13619, Estonia
GSK Investigational Site
Tartu, 50106, Estonia
GSK Investigational Site
Espoo, 02230, Finland
GSK Investigational Site
Helsinki, 00100, Finland
GSK Investigational Site
Helsinki, 00930, Finland
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Kokkola, 67100, Finland
GSK Investigational Site
Oulu, 90220, Finland
GSK Investigational Site
Pori, 28100, Finland
GSK Investigational Site
Seinäjoki, 60100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Angers, 49000, France
GSK Investigational Site
Château-Gontier, 53200, France
GSK Investigational Site
Cherbourg, 50100, France
GSK Investigational Site
Clermont-Ferrand, 63003, France
GSK Investigational Site
Laval, 53000, France
GSK Investigational Site
Laval, 53100, France
GSK Investigational Site
Montrevault, 49110, France
GSK Investigational Site
Muret, 31600, France
GSK Investigational Site
Nantes, 44300, France
GSK Investigational Site
Rosiers-d'Égletons, 19300, France
GSK Investigational Site
Saint Cyr Sur Loir, 37540, France
GSK Investigational Site
Segré, 49500, France
GSK Investigational Site
Soulaines-sur-Aubance, 49610, France
GSK Investigational Site
Tours, 37100, France
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326, Germany
GSK Investigational Site
Güglingen, Baden-Wurttemberg, 74363, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72074, Germany
GSK Investigational Site
Wangen, Baden-Wurttemberg, 88239, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Dachau, Bavaria, 85221, Germany
GSK Investigational Site
Künzing, Bavaria, 94550, Germany
GSK Investigational Site
Munich, Bavaria, 80339, Germany
GSK Investigational Site
Rednitzhembach, Bavaria, 91126, Germany
GSK Investigational Site
Wallerfing, Bavaria, 94574, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14467, Germany
GSK Investigational Site
Flörsheim, Hesse, 65439, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Duelmen, Lower Saxony, 48249, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Dresden, Saxony, 01097, Germany
GSK Investigational Site
Freiberg, Saxony, 09599, Germany
GSK Investigational Site
Leipzig, Saxony, 04315, Germany
GSK Investigational Site
Pirna, Saxony, 01796, Germany
GSK Investigational Site
Köthen, Saxony-Anhalt, 06366, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23554, Germany
GSK Investigational Site
Berlin, 10629, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Berlin, 12351, Germany
GSK Investigational Site
Berlin, 13347, Germany
GSK Investigational Site
Hamburg, 20251, Germany
GSK Investigational Site
Hamburg, 22143, Germany
GSK Investigational Site
Hamburg, 22415, Germany
GSK Investigational Site
Kwun Tong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Chieti, Abruzzo, 66013, Italy
GSK Investigational Site
Pescara, Abruzzo, 65100, Italy
GSK Investigational Site
Rome, Lazio, 00163, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Monza, Lombardy, 20052, Italy
GSK Investigational Site
Cuneo, Piedmont, 12100, Italy
GSK Investigational Site
Cagliari, Sardinia, 09127, Italy
GSK Investigational Site
Sassari, Sardinia, 07100, Italy
GSK Investigational Site
Catania, Sicily, 95129, Italy
GSK Investigational Site
Ragusa (RG), Sicily, 97100, Italy
GSK Investigational Site
Fukuoka, 810-0021, Japan
GSK Investigational Site
Fukuoka, 812-0025, Japan
GSK Investigational Site
Fukuoka, 813-8588, Japan
GSK Investigational Site
Fukuoka, 816-0864, Japan
GSK Investigational Site
Kanagawa, 224-8503, Japan
GSK Investigational Site
Kanagawa, 247-8533, Japan
GSK Investigational Site
Kyoto, 611-0041, Japan
GSK Investigational Site
Tokyo, 141-0001, Japan
GSK Investigational Site
Tokyo, 142-8666, Japan
GSK Investigational Site
Tokyo, 154-0024, Japan
GSK Investigational Site
Zapopan, Jalisco, Jalisco, 45190, Mexico
GSK Investigational Site
Cuernavaca, Morelos, 62210, Mexico
GSK Investigational Site
Durango, 34000, Mexico
GSK Investigational Site
Monterrey, Mexico
GSK Investigational Site
Ansan, 425-707, South Korea
GSK Investigational Site
Bucheon-si, 420-767, South Korea
GSK Investigational Site
Incheon, 400-711, South Korea
GSK Investigational Site
Kangnam-gu, Seoul, South Korea
GSK Investigational Site
Kangwon-do, 220-701, South Korea
GSK Investigational Site
Seoul, 135-710, South Korea
GSK Investigational Site
Seoul, 150-950, South Korea
GSK Investigational Site
Seoul, 152-703, South Korea
GSK Investigational Site
Alcover( Tarragona), 43460, Spain
GSK Investigational Site
Balenyà (Barcelona), 08550, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Centelles, Spain
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Majadahonda, Spain
GSK Investigational Site
Peralada( Girona), 17491, Spain
GSK Investigational Site
Valencia, 46020, Spain
GSK Investigational Site
Vic/ Barcelona, 08500, Spain
GSK Investigational Site
Borås, SE-506 30, Sweden
GSK Investigational Site
Eskilstuna, SE-631 88, Sweden
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Jönköping, SE-551 85, Sweden
GSK Investigational Site
Karlskrona, SE-371 41, Sweden
GSK Investigational Site
Linköping, SE-58758, Sweden
GSK Investigational Site
Malmo, SE-211 52, Sweden
GSK Investigational Site
Örebro, SE-703 62, Sweden
GSK Investigational Site
Skövde, SE-541 85, Sweden
GSK Investigational Site
Stockholm, SE-111 57, Sweden
GSK Investigational Site
Uppsala, SE-751 85, Sweden
GSK Investigational Site
Vällingby, SE-162 68, Sweden
GSK Investigational Site
Taichung, 40447, Taiwan
GSK Investigational Site
Taipei, 112, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Taoyuan District, 333, Taiwan
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, PR7 7NA, United Kingdom
GSK Investigational Site
Atherstone, Warwickshire, CV9 1EU, United Kingdom
GSK Investigational Site
Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom
GSK Investigational Site
Bangor, BT19 1PP, United Kingdom
GSK Investigational Site
Belfast, BT7 2EB, United Kingdom
GSK Investigational Site
Broughshane, BT42 4JP, United Kingdom
GSK Investigational Site
Ledbury, HR8 2AA, United Kingdom
GSK Investigational Site
Newtonabbey, BT37 9QW, United Kingdom
GSK Investigational Site
Waterloo, Liverpool, L22 0LG, United Kingdom
Related Publications (12)
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.
PMID: 27626517BACKGROUNDCunningham 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.
PMID: 29529222BACKGROUNDIkematsu 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.
BACKGROUNDKovac 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.
PMID: 29463421BACKGROUNDMatthews 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.
PMID: 37166199DERIVEDKim 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.
PMID: 36066965DERIVEDKim 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.
PMID: 33606577DERIVEDDagnew 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.
PMID: 32910152DERIVEDColindres 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.
PMID: 32347767DERIVEDWiller 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.
PMID: 31537443DERIVEDLopez-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.
PMID: 30935742DERIVEDCurran 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.
PMID: 29955836DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2010
First Posted
July 19, 2010
Study Start
August 2, 2010
Primary Completion
July 24, 2015
Study Completion
July 24, 2015
Last Updated
April 27, 2020
Results First Posted
November 20, 2017
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.