Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
Launched by GLAXOSMITHKLINE · Jul 15, 2010
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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.
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Genova, Liguria, Italy
San Antonio, Texas, United States
Charlotte, North Carolina, United States
Madrid, , Spain
Somers Point, New Jersey, United States
Turku, , Finland
Sassari, Sardegna, Italy
Hickory, North Carolina, United States
Richmond, Virginia, United States
Clearwater, Florida, United States
West Palm Beach, Florida, United States
Kansas City, Missouri, United States
Cary, North Carolina, United States
Winston Salem, North Carolina, United States
Norfolk, Virginia, United States
Westmead, New South Wales, Australia
Kippa Ring, Queensland, Australia
Vancouver, British Columbia, Canada
Pointe Claire, Quebec, Canada
Dachau, Bayern, Germany
Dresden, Sachsen, Germany
Leipzig, Sachsen, Germany
Pirna, Sachsen, Germany
Berlin, , Germany
Durango, , Mexico
Barcelona, , Spain
Buckshaw Village, Chorley, Lancashire, United Kingdom
Waterloo, Liverpool, , United Kingdom
Mesa, Arizona, United States
Wichita, Kansas, United States
Halifax, Nova Scotia, Canada
Truro, Nova Scotia, Canada
Toronto, Ontario, Canada
Spring Valley, California, United States
Jacksonville, Florida, United States
Bristol, Tennessee, United States
Deland, Florida, United States
Meridian, Idaho, United States
Wilmington, North Carolina, United States
Phoenix, Arizona, United States
Angers, , France
Mannheim, Baden Wuerttemberg, Germany
Kuenzing, Bayern, Germany
Wallerfing, Bayern, Germany
Potsdam, Brandenburg, Germany
Goch, Nordrhein Westfalen, Germany
Koeln, Nordrhein Westfalen, Germany
Rhaunen, Rheinland Pfalz, Germany
Seoul, , Korea, Republic Of
Mainz, Rheinland Pfalz, Germany
Berlin, , Germany
Shatin, , Hong Kong
Salisbury, North Carolina, United States
Laval, , France
Taipei, , Taiwan
Taoyuan, , Taiwan
Caboolture, Queensland, Australia
Baltimore, Maryland, United States
Göteborg, , Sweden
Kwun Tong, , Hong Kong
Murray, Utah, United States
Vista, California, United States
Las Vegas, Nevada, United States
Wuerzburg, Bayern, Germany
Koethen, Sachsen Anhalt, Germany
Columbia, Maryland, United States
Cleveland, Ohio, United States
Winchester, Virginia, United States
Gatineau, Quebec, Canada
Mirabel, Quebec, Canada
Deggingen, Baden Wuerttemberg, Germany
Weinheim, Baden Wuerttemberg, Germany
Mainz, Rheinland Pfalz, Germany
Tucson, Arizona, United States
Helsinki, , Finland
Muenchen, Bayern, Germany
Witten, Nordrhein Westfalen, Germany
Pescara, Abruzzo, Italy
Essen, Nordrhein Westfalen, Germany
Mount Pleasant, South Carolina, United States
Trois Rivières, Quebec, Canada
Carnegie, Pennsylvania, United States
Jarvenpaa, , Finland
Oulu, , Finland
Pori, , Finland
Seinajoki, , Finland
Tampere, , Finland
Frankfurt, Hessen, Germany
Roma, Lazio, Italy
Zapopan, Jalisco, Jalisco, Mexico
Duelmen, Niedersachsen, Germany
Bucheon Si,, , Korea, Republic Of
Kokkola, , Finland
Leipzig, Sachsen, Germany
Nantes, , France
Eskilstuna, , Sweden
Quebec, , Canada
Karlskrona, , Sweden
Hradec Kralove, , Czechia
Stockholm, , Sweden
Uppsala, , Sweden
Bay Roberts, Newfoundland And Labrador, Canada
Jönköping, , Sweden
Tours, , France
Geelong, Victoria, Australia
Victoria, British Columbia, Canada
Rednitzhembach, Bayern, Germany
Wangen, Baden Wuerttemberg, Germany
Incheon, , Korea, Republic Of
Umina, New South Wales, Australia
Curitiba/Paraná, Paraná, Brazil
Skövde, , Sweden
Freiberg, Sachsen, Germany
Magdeburg, Sachsen Anhalt, Germany
Edison, New Jersey, United States
Cagliari, Sardegna, Italy
Segré, , France
Gueglingen, Baden Wuerttemberg, Germany
Tallinn, , Estonia
Uniontown, Pennsylvania, United States
Muret, , France
Chieti, Abruzzo, Italy
Malmö, , Sweden
Centelles, , Spain
Tokyo, , Japan
Monza, Lombardia, Italy
Tuebingen, Baden Wuerttemberg, Germany
Quebec City, Quebec, Canada
Ansan, , Korea, Republic Of
Overland Park, Kansas, United States
Tartu, , Estonia
Château Gontier, , France
Clermont Ferrand, , France
Rosiers D'egletons, , France
Floersheim, Hessen, Germany
Luebeck, Schleswig Holstein, Germany
Cuernavaca, Morelos, Mexico
Pleasant Hills, Pennsylvania, United States
Renton, Washington, United States
Cuneo, Piemonte, Italy
Wadsworth, Ohio, United States
Catania, Sicilia, Italy
Vällingby, , Sweden
örebro, , Sweden
Kangwon Do, , Korea, Republic Of
Quebec, , Canada
Hamburg, , Germany
Bradford On Avon, Wiltshire, United Kingdom
Woodstock, Ontario, Canada
Porto Alegre, Rio Grande Do Sul, Brazil
Monterrey, , Mexico
Kanagawa, , Japan
Fukuoka, , Japan
Kyoto, , Japan
Greer, South Carolina, United States
Arlington, Virginia, United States
Glebe, New South Wales, Australia
Maroubra, New South Wales, Australia
Wollongong, New South Wales, Australia
Ivanhoe, Victoria, Australia
Belo Horizonte, Minas Gerais, Brazil
Curitiba/Pr, , Brazil
São Paulo, , Brazil
Sherbrooke, Quebec, Canada
Brno, , Czechia
Ceske Budejovice, , Czechia
Espoo, , Finland
Cherbourg, , France
Montrevault, , France
Saint Cyr Sur Loir, , France
Soulaines Sur Aubance, , France
Ragusa (Rg), Sicilia, Italy
Kangnam Gu, Seoul, , Korea, Republic Of
Cuernavaca, Morelos, Mexico
Alcover( Tarragona), , Spain
Balenyà (Barcelona), , Spain
La Roca Del Valles (Barcelona), , Spain
Majadahonda, , Spain
Peralada( Girona), , Spain
Valencia, , Spain
Vic/ Barcelona, , Spain
Borås, , Sweden
Linköping, , Sweden
Taichung, , Taiwan
Atherstone, Warwickshire, United Kingdom
Bangor, , United Kingdom
Belfast, , United Kingdom
Broughshane, , United Kingdom
Ledbury, , United Kingdom
Newtonabbey, , United Kingdom
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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