A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022

NCT03563183 | Completed Results FDA Drug

• 1 other identifier: 204878
• Study Type: observational
• Target: 26,976
• Locations: 17 countries
• Sites: 167

Brief Summary

As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

Conditions

Herpes Zoster

Keywords

immunogenicity; Herpes Zoster; efficacy; safety; frailty; Shingles vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects by Frailty Status, at Baseline

  Frailty status was measured in relation to the accumulation of deficits using a Frailty Index (FI) adapted from the model proposed by Mitnitski et al. \[Mitnitski, 2001\]. The different aspects of frailty composing the FI were assessed through the medical history and components of the Short Form 36 Questionnaire (SF-36) and EuroQol (EQ)-5D questionnaires recorded pre-vaccination Dose 1 (in the study ZOSTER-006\[NCT01165177\] and ZOSTER-022\[NCT01165229\]). If the FI was less than or equal to 0.08, the subject was classified as Non-Frail. If the score was greater than 0.08 but less than or equal to 0.25, the subject was classified as pre-frail. If the score was greater than 0.25, the subject was classified as Frail. Subjects without a FI score were classified as unknown.

  At Baseline (Month 0)

Secondary Outcomes (13)

• Distribution of Short Form 36 (SF-36) Questionnaire Scale Scores, by Country

  At Month 0, 14, 26 and 38

• Distribution of EuroQol (EQ)-5D Questionnaire Scale Scores, by Country

  At Month 0, 14, 26 and 38

• Incidence Rate (Per 1000 Person-years) of Confirmed Herpes Zoster (HZ) Cases, by Frailty Status

  During the entire study period (3 to 5 year period following Day 0)

• Herpes Zoster Burden of Illness Score, by Frailty Status

  During the entire study period (3 to 5 year period following Day 0)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Frailty Status

  Within 7 days (Days 0-6) after each vaccination

Study Arms (1)

Overall Group

Adults aged ≥50 years of age in the Zoster-064 TVC who received herpes zoster subunit (HZ/su) vaccine or Placebo in Zoster-006/022 study

Other: Encoding of data collected in Zoster 006 and Zoster 022 studies

Interventions

Encoding of data collected in Zoster 006 and Zoster 022 studies OTHER

Not applicable (disease epidemiology study)

Overall Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects enrolled in the Zoster 006 and Zoster 022 studies

You may qualify if:

• All subjects who participated in the Zoster 006 and Zoster 022 trials.
• Subjects who died or were lost to follow-up during ZOSTER-006 and ZOSTER-022 will be considered for enrolment in ZOSTER-064 and their data/questionnaires up to that point will be used.

You may not qualify if:

• Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER-022. This will include any subject eliminated following deviations from GCP compliance.
• Subjects who developed a suspected HZ case during ZOSTER-006 and ZOSTER-022 (since their QoL questionnaires were encoded in the eCRF for ZOSTER-006 and ZOSTER-022).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (169)

GSK Investigational Site

Mesa, Arizona, 85213, United States

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GSK Investigational Site

Phoenix, Arizona, 85018, United States

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GSK Investigational Site

Phoenix, Arizona, 85020, United States

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GSK Investigational Site

Spring Valley, California, 91978, United States

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GSK Investigational Site

Clearwater, Florida, 33761, United States

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GSK Investigational Site

DeLand, Florida, 32720, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32216, United States

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West Palm Beach, Florida, 33409, United States

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Meridian, Idaho, 83642, United States

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Wichita, Kansas, 67207, United States

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Kansas City, Missouri, 64114, United States

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GSK Investigational Site

Cary, North Carolina, 27518, United States

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GSK Investigational Site

Charlotte, North Carolina, 28209, United States

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GSK Investigational Site

Hickory, North Carolina, 28601, United States

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Mt Pleasant, North Carolina, 29464, United States

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Salisbury, North Carolina, 28144, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Beachwood, Ohio, 44122, United States

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Wadsworth, Ohio, 44281, United States

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Pleasant Hills, Pennsylvania, 15236, United States

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Uniontown, Pennsylvania, 15401, United States

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Greer, South Carolina, 29651, United States

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Bristol, Tennessee, 37620, United States

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San Antonio, Texas, 78229, United States

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GSK Investigational Site

Murray, Utah, 84123, United States

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Newport News, Virginia, 23606, United States

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Richmond, Virginia, 23294, United States

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Winchester, Virginia, 22601, United States

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Renton, Washington, 98057, United States

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Maroubra, New South Wales, 2035, Australia

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Umina, New South Wales, 2257, Australia

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Westmead, New South Wales, 2145, Australia

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Wollongong, New South Wales, 2522, Australia

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Sherwood, Queensland, 4075, Australia

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Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Curitiba, Paraná, 80810-050, Brazil

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Curitiba/PR, 80240-280, Brazil

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São Paulo, 04023-900, Brazil

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GSK Investigational Site

São Paulo, 04266-010, Brazil

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GSK Investigational Site

São Paulo, 05403-000, Brazil

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GSK Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

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Victoria, British Columbia, V8V 3M9, Canada

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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

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Halifax, Nova Scotia, B3K 6R8, Canada

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Truro, Nova Scotia, B2N 1L2, Canada

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Toronto, Ontario, M4S 1Y2, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Woodstock, Ontario, N4S 5P5, Canada

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Gatineau, Quebec, J8Y 6S8, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Québec, Quebec, G1E 7G9, Canada

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Québec, Quebec, G1W 4R4, Canada

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Sherbrooke, Quebec, J1H 2G2, Canada

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Hradec Králové, Czechia

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Tallinn, 13619, Estonia

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Tartu, 50106, Estonia

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Tampereen Yliopisto, 33014, Finland

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Angers, 49000, France

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Angers, 49100, France

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GSK Investigational Site

Château-Gontier, 53200, France

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Cherbourg, 50100, France

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Clermont-Ferrand, 63003, France

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Laval, 53000, France

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Montrevault, 49110, France

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Muret, 31600, France

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GSK Investigational Site

Mûrs-Erigné, 49610, France

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Nantes, 44277, France

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GSK Investigational Site

Rosiers-d'Égletons, 19300, France

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GSK Investigational Site

Saint-Cyr-sur-Loire, 37540, France

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GSK Investigational Site

Segré, 49500, France

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GSK Investigational Site

Tours, 37100, France

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Deggingen, Baden-Wurttemberg, 73326, Germany

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Güglingen, Baden-Wurttemberg, 74363, Germany

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Mannheim, Baden-Wurttemberg, 68161, Germany

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Tübingen, Baden-Wurttemberg, 72074, Germany

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GSK Investigational Site

Wangen, Baden-Wurttemberg, 88239, Germany

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GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

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GSK Investigational Site

Dachau, Bavaria, 85221, Germany

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GSK Investigational Site

Künzing, Bavaria, 94550, Germany

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Munich, Bavaria, 80339, Germany

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Rednitzhembach, Bavaria, 91126, Germany

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Wallerfing, Bavaria, 94574, Germany

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Würzburg, Bavaria, 97070, Germany

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GSK Investigational Site

Flörsheim, Hesse, 65439, Germany

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Frankfurt am Main, Hesse, 60389, Germany

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Duelmen, Lower Saxony, 48249, Germany

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Cologne, North Rhine-Westphalia, 51069, Germany

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Essen, North Rhine-Westphalia, 45355, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

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GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

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GSK Investigational Site

Witten, North Rhine-Westphalia, 58455, Germany

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Mainz, Rhineland-Palatinate, 55116, Germany

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Rhaunen, Rhineland-Palatinate, 55624, Germany

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Dresden, Saxony, 01097, Germany

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Freiberg, Saxony, 09599, Germany

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Leipzig, Saxony, 04315, Germany

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Pirna, Saxony, 01796, Germany

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Lübeck, Schleswig-Holstein, 23554, Germany

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GSK Investigational Site

Berlin, 10629, Germany

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GSK Investigational Site

Berlin, 10717, Germany

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GSK Investigational Site

Berlin, 10787, Germany

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Berlin, 12157, Germany

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Berlin, 13347, Germany

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Hamburg, 20251, Germany

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GSK Investigational Site

Hamburg, 22143, Germany

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GSK Investigational Site

Hamburg, 22415, Germany

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GSK Investigational Site

Magdeburg, 39120, Germany

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GSK Investigational Site

Kwun Tong, Hong Kong

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GSK Investigational Site

Shatin, Hong Kong

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GSK Investigational Site

Chieti, Abruzzo, 66013, Italy

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GSK Investigational Site

Pescara, Abruzzo, 65100, Italy

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GSK Investigational Site

Rome, Lazio, 00133, Italy

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Rome, Lazio, 00163, Italy

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Genoa, Liguria, 16132, Italy

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GSK Investigational Site

Monza, Lombardy, 20900, Italy

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GSK Investigational Site

Cuneo, Piedmont, 12100, Italy

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GSK Investigational Site

Fukuoka, 810-0021, Japan

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GSK Investigational Site

Fukuoka, 812-0025, Japan

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GSK Investigational Site

Fukuoka, 813-8588, Japan

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GSK Investigational Site

Kanagawa, 224-8503, Japan

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GSK Investigational Site

Tokyo, 141-0001, Japan

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GSK Investigational Site

Tokyo, 142-8666, Japan

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GSK Investigational Site

Tokyo, 154-0024, Japan

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GSK Investigational Site

Zapopan, Jalisco, Jalisco, 45190, Mexico

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GSK Investigational Site

Durango, 34000, Mexico

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GSK Investigational Site

Gangwon-do, 26426, South Korea

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Gyeonggi-do, 14584, South Korea

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GSK Investigational Site

Gyeonggi-do, 15355, South Korea

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GSK Investigational Site

Incheon, 400-711, South Korea

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GSK Investigational Site

Seoul, 06273, South Korea

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GSK Investigational Site

Seoul, 06351, South Korea

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GSK Investigational Site

Seoul, 07441, South Korea

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GSK Investigational Site

Seoul, 08308, South Korea

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GSK Investigational Site

Alcover( Tarragona), 43460, Spain

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GSK Investigational Site

Balenyà (Barcelona), 08550, Spain

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GSK Investigational Site

Barcelona, 08025, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Centelles (Barcelona), 08540, Spain

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GSK Investigational Site

La Roca Del Valles (Barcelona), 08430, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Majadahonda( Madrid, 28222, Spain

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GSK Investigational Site

Marid, 28040, Spain

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GSK Investigational Site

Peralada( Girona), 17491, Spain

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GSK Investigational Site

Valencia, 46020, Spain

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GSK Investigational Site

Vic/ Barcelona, 08500, Spain

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GSK Investigational Site

Borås, SE-506 30, Sweden

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GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

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GSK Investigational Site

Gothenburg, SE-413 45, Sweden

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GSK Investigational Site

Jönköping, SE-551 85, Sweden

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GSK Investigational Site

Karlskrona, SE-371 41, Sweden

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GSK Investigational Site

Linköping, SE-581 85, Sweden

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GSK Investigational Site

Malmo, SE-211 52, Sweden

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GSK Investigational Site

Örebro, SE-703 62, Sweden

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GSK Investigational Site

Uppsala, SE-751 85, Sweden

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GSK Investigational Site

Vällingby, SE-162 68, Sweden

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GSK Investigational Site

Taichung, 40447, Taiwan

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GSK Investigational Site

Taipei, 100, Taiwan

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GSK Investigational Site

Taipei, 112, Taiwan

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GSK Investigational Site

Taoyuan, 333, Taiwan

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GSK Investigational Site

Atherstone, Warwickshire, CV9 1EU, United Kingdom

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GSK Investigational Site

Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom

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GSK Investigational Site

Bangor, BT19 1NB, United Kingdom

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GSK Investigational Site

Belfast, BT7 2EB, United Kingdom

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GSK Investigational Site

Broughshane, BT42 4JP, United Kingdom

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GSK Investigational Site

Liverpool, L22 0LG, United Kingdom

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GSK Investigational Site

Newtonabbey, BT37 9QW, United Kingdom

Location

Related Publications (1)

• Curran D, Kim JH, Matthews S, Dessart C, Levin MJ, Oostvogels L, Riley ME, Schmader KE, Cunningham AL, McNeil SA, Schuind AE, Andrew MK; Zoster-064 Study Group. Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals. J Am Geriatr Soc. 2021 Mar;69(3):744-752. doi: 10.1111/jgs.16917. Epub 2020 Nov 16.

  PMID: 33197294 DERIVED

MeSH Terms

Conditions

Herpes Zoster; Frailty

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 20, 2018
• Study Start: June 5, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: April 30, 2020
• Results First Posted: April 30, 2020

Record last verified: 2020-04

Locations

FI (1); CA (14); CZ (1); FR (14); ME (2); AU (5); SE (10); HK (2); TW (4); JP (7); US (31); DE (36); IT (7); ES (12); BR (6); KR (8); GB (7)