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

NCT ID: NCT03563183

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26976 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2019-04-30

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.

Detailed Description

As part of the study procedure, each subject enrolled in studies Zoster-006 and Zoster-022 was asked to complete two quality of life (QoL) questionnaires named respectively SF-36 and EQ-5D at predefined study time points. These questionnaires were to provide relevant information about the quality of life (functional status, ability to socialize, mental health, etc.) of subjects before they develop shingles Extracting some elements of the Quality of Life questionnaires (QoL), EQ-5D and SF-36, completed by all study subjects at baseline, and combining them with other medical history data allows attributing of frailty scores.

Analyses pertaining to efficacy, safety and immunogenicity as per frailty score might be performed according to the methodology used in the ZOSTER-006 and ZOSTER-022 studies.

Additionally, the data collected can be used to assess if some physical, physiological and/or psychological characteristics reported by the subjects before the onset of HZ would be predictive of HZ.

Conditions

Herpes Zoster

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Encoding of data collected in Zoster 006 and Zoster 022 studies

Intervention Type: OTHER

Not applicable (disease epidemiology study)

Interventions

Encoding of data collected in Zoster 006 and Zoster 022 studies

Not applicable (disease epidemiology study)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Spring Valley, California, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

DeLand, Florida, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Meridian, Idaho, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Cary, North Carolina, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Hickory, North Carolina, United States

GSK Investigational Site

Mt Pleasant, North Carolina, United States

GSK Investigational Site

Salisbury, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Beachwood, Ohio, United States

GSK Investigational Site

Wadsworth, Ohio, United States

GSK Investigational Site

Pleasant Hills, Pennsylvania, United States

GSK Investigational Site

Uniontown, Pennsylvania, United States

GSK Investigational Site

Greer, South Carolina, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Murray, Utah, United States

GSK Investigational Site

Newport News, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Winchester, Virginia, United States

GSK Investigational Site

Renton, Washington, United States

GSK Investigational Site

Maroubra, New South Wales, Australia

GSK Investigational Site

Umina, New South Wales, Australia

GSK Investigational Site

Westmead, New South Wales, Australia

GSK Investigational Site

Wollongong, New South Wales, Australia

GSK Investigational Site

Sherwood, Queensland, Australia

GSK Investigational Site

Belo Horizonte, Minas Gerais, Brazil

GSK Investigational Site

Curitiba, Paraná, Brazil

GSK Investigational Site

Curitiba/PR, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

Victoria, British Columbia, Canada

GSK Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Woodstock, Ontario, Canada

GSK Investigational Site

Gatineau, Quebec, Canada

GSK Investigational Site

Mirabel, Quebec, Canada

GSK Investigational Site

Pointe-Claire, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Tampereen Yliopisto, , Finland

GSK Investigational Site

Angers, , France

GSK Investigational Site

Angers, , France

GSK Investigational Site

Château-Gontier, , France

GSK Investigational Site

Cherbourg, , France

GSK Investigational Site

Clermont-Ferrand, , France

GSK Investigational Site

Laval, , France

GSK Investigational Site

Montrevault, , France

GSK Investigational Site

Muret, , France

GSK Investigational Site

Mûrs-Erigné, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Rosiers-d'Égletons, , France

GSK Investigational Site

Saint-Cyr-sur-Loire, , France

GSK Investigational Site

Segré, , France

GSK Investigational Site

Tours, , France

GSK Investigational Site

Deggingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Güglingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Wangen, Baden-Wurttemberg, Germany

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Dachau, Bavaria, Germany

GSK Investigational Site

Künzing, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Rednitzhembach, Bavaria, Germany

GSK Investigational Site

Wallerfing, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Flörsheim, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Duelmen, Lower Saxony, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Witten, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Freiberg, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Pirna, Saxony, Germany

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Magdeburg, , Germany

GSK Investigational Site

Kwun Tong, , Hong Kong

GSK Investigational Site

Shatin, , Hong Kong

GSK Investigational Site

Chieti, Abruzzo, Italy

GSK Investigational Site

Pescara, Abruzzo, Italy

GSK Investigational Site

Rome, Lazio, Italy

GSK Investigational Site

Rome, Lazio, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Monza, Lombardy, Italy

GSK Investigational Site

Cuneo, Piedmont, Italy

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Zapopan, Jalisco, Jalisco, Mexico

GSK Investigational Site

Durango, , Mexico

GSK Investigational Site

Gangwon-do, , South Korea

GSK Investigational Site

Gyeonggi-do, , South Korea

GSK Investigational Site

Gyeonggi-do, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Alcover( Tarragona), , Spain

GSK Investigational Site

Balenyà (Barcelona), , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Centelles (Barcelona), , Spain

GSK Investigational Site

La Roca Del Valles (Barcelona), , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Majadahonda( Madrid, , Spain

GSK Investigational Site

Marid, , Spain

GSK Investigational Site

Peralada( Girona), , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Vic/ Barcelona, , Spain

GSK Investigational Site

Borås, , Sweden

GSK Investigational Site

Eskilstuna, , Sweden

GSK Investigational Site

Gothenburg, , Sweden

GSK Investigational Site

Jönköping, , Sweden

GSK Investigational Site

Karlskrona, , Sweden

GSK Investigational Site

Linköping, , Sweden

GSK Investigational Site

Malmo, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Uppsala, , Sweden

GSK Investigational Site

Vällingby, , Sweden

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan, , Taiwan

GSK Investigational Site

Atherstone, Warwickshire, United Kingdom

GSK Investigational Site

Bradford-on-Avon, Wiltshire, United Kingdom

GSK Investigational Site

Bangor, , United Kingdom

GSK Investigational Site

Belfast, , United Kingdom

GSK Investigational Site

Broughshane, , United Kingdom

GSK Investigational Site

Liverpool, , United Kingdom

GSK Investigational Site

Newtonabbey, , United Kingdom

Countries

United States; Australia; Brazil; Canada; Czechia; Estonia; Finland; France; Germany; Hong Kong; Italy; Japan; Mexico; South Korea; Spain; Sweden; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33197294 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

204878

Identifier Type: -

Identifier Source: org_study_id