Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Herpes Zoster Clinical Trial

Official title:

Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165177
• Other study ID #: 110390
• Secondary ID: 2008-000367-42
• Status: Completed
• Phase: Phase 3
• Start date: August 2, 2010
• Est. completion date: July 27, 2015

Study information

• Verified date: January 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ≥ 50 years.

Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being 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. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.

Description:

This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints and the analyses of the objectives in 2 steps.

Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA, and other pre-specified endpoints will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16165
• Est. completion date: July 27, 2015
• Est. primary completion date: May 9, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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 50 years or older at the time of the first vaccination;

• Female subjects of non-childbearing potential may be enrolled in the study;

For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;

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 enrollment;

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Pregnant or lactating female;

• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
• Placebo
Intramuscular injection

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Geelong	Victoria
Australia	GSK Investigational Site	Glebe	New South Wales
Australia	GSK Investigational Site	Ivanhoe	Victoria
Australia	GSK Investigational Site	Maroubra	New South Wales
Australia	GSK Investigational Site	Sherwood	Queensland
Australia	GSK Investigational Site	Umina	New South Wales
Australia	GSK Investigational Site	Westmead	New South Wales
Australia	GSK Investigational Site	Wollongong	New South Wales
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Curitiba/Paraná	Paraná
Brazil	GSK Investigational Site	Curitiba/Paraná	Paraná
Brazil	GSK Investigational Site	Curitiba/PR
Brazil	GSK Investigational Site	Curitiba/PR
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Canada	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Gatineau	Quebec
Canada	GSK Investigational Site	Gatineau	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Mirabel	Quebec
Canada	GSK Investigational Site	Mirabel	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Quebec City	Quebec
Canada	GSK Investigational Site	Quebec City	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois Rivières	Quebec
Canada	GSK Investigational Site	Trois Rivières	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Woodstock	Ontario
Canada	GSK Investigational Site	Woodstock	Ontario
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Ceske Budejovice
Czechia	GSK Investigational Site	Hradec Kralove
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Kokkola
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
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	Laval
France	GSK Investigational Site	Montrevault
France	GSK Investigational Site	Muret
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Rosiers d'Egletons
France	GSK Investigational Site	Saint Cyr Sur Loir
France	GSK Investigational Site	Segré
France	GSK Investigational Site	Soulaines sur Aubance
France	GSK Investigational Site	Tours
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	Berlin
Germany	GSK Investigational Site	Dachau	Bayern
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Duelmen	Niedersachsen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Floersheim	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freiberg	Sachsen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koethen	Sachsen-Anhalt
Germany	GSK Investigational Site	Kuenzing	Bayern
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Pirna	Sachsen
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Rednitzhembach	Bayern
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wallerfing	Bayern
Germany	GSK Investigational Site	Wangen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Hong Kong	GSK Investigational Site	Kwun Tong
Hong Kong	GSK Investigational Site	Shatin
Italy	GSK Investigational Site	Cagliari	Sardegna
Italy	GSK Investigational Site	Catania	Sicilia
Italy	GSK Investigational Site	Chieti	Abruzzo
Italy	GSK Investigational Site	Cuneo	Piemonte
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Monza	Lombardia
Italy	GSK Investigational Site	Pescara	Abruzzo
Italy	GSK Investigational Site	Ragusa (RG)	Sicilia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sassari	Sardegna
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Ansan
Korea, Republic of	GSK Investigational Site	Ansan
Korea, Republic of	GSK Investigational Site	Bucheon-si,
Korea, Republic of	GSK Investigational Site	Bucheon-si,
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Kangnam-gu, Seoul
Korea, Republic of	GSK Investigational Site	Kangwon-do
Korea, Republic of	GSK Investigational Site	Kangwon-do
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Mexico	GSK Investigational Site	Cuernavaca	Morelos
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Monterrey
Mexico	GSK Investigational Site	Zapopan, Jalisco	Jalisco
Spain	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
Spain	GSK Investigational Site	La Roca Del Valles (Barcelona)
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda
Spain	GSK Investigational Site	Peralada( Girona)
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vic/ Barcelona
Sweden	GSK Investigational Site	Borås
Sweden	GSK Investigational Site	Borås
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Jönköping
Sweden	GSK Investigational Site	Jönköping
Sweden	GSK Investigational Site	Karlskrona
Sweden	GSK Investigational Site	Karlskrona
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Skövde
Sweden	GSK Investigational Site	Skövde
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uppsala
Sweden	GSK Investigational Site	Uppsala
Sweden	GSK Investigational Site	Vällingby
Sweden	GSK Investigational Site	Vällingby
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan
United Kingdom	GSK Investigational Site	Atherstone	Warwickshire
United Kingdom	GSK Investigational Site	Atherstone	Warwickshire
United Kingdom	GSK Investigational Site	Bangor
United Kingdom	GSK Investigational Site	Bangor
United Kingdom	GSK Investigational Site	Belfast
United Kingdom	GSK Investigational Site	Belfast
United Kingdom	GSK Investigational Site	Bradford on Avon	Wiltshire
United Kingdom	GSK Investigational Site	Bradford on Avon	Wiltshire
United Kingdom	GSK Investigational Site	Broughshane
United Kingdom	GSK Investigational Site	Broughshane
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Ledbury
United Kingdom	GSK Investigational Site	Ledbury
United Kingdom	GSK Investigational Site	Newtonabbey
United Kingdom	GSK Investigational Site	Newtonabbey
United Kingdom	GSK Investigational Site	Waterloo, Liverpool
United Kingdom	GSK Investigational Site	Waterloo, Liverpool
United States	GSK Investigational Site	Arlington	Virginia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Carnegie	Pennsylvania
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Columbia	Maryland
United States	GSK Investigational Site	DeLand	Florida
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Meridian	Idaho
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pleasant Hills	Pennsylvania
United States	GSK Investigational Site	Renton	Washington
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Somers Point	New Jersey
United States	GSK Investigational Site	Spring Valley	California
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	Vista	California
United States	GSK Investigational Site	Wadsworth	Ohio
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winchester	Virginia
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

References & Publications (5)

Cunningham 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. — View Citation

Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Díez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barberà 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. — View Citation

Ikematsu 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.

Kovac 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. — View Citation

Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barberà J, Vesikari T, Watanabe D, Weckx L, Zahaf T, Heineman TC; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087-96. doi: 10.1056/NEJMoa1501184. Epub 2015 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Confirmed Herpes Zoster (HZ) Cases	Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)	The incidence of PHN was calculated using the modified total vaccinated chort.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain	Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Confirmed HZ Episode Related Mortality	The analysis focused on the number of subjects who died due to HZ	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With HZ Related Complications	The analysis focused on the incidence of HZ complications in subjects with confirmed HZ	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Confirmed HZ Episode Related Hospitalizations	The analysis focused on confirmed HZ episode related hospitalizations.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ	The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ	The analysis focused on subjects taking pain medication due to HZ	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Days With Severe 'Worst' HZ-associated Pain.	Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations	The analysis focused on confirmed HZ episode related hospitalizations and deaths.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With HZ Related Complications, by Complication Type	Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Distribution of Pain Medication Associated With HZ	The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Days of Pain Medication Associated With HZ	The analysis was performed on subjects with a confirmed HZ episode	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.	During the 7-day (Days 0-6) post-vaccination period
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, GI (gastrointestinal) symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	Within the 7-day (Days 0-6) post-vaccination period
Secondary	Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)	Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated	Within the 7-day (Days 0-6) post-vaccination period
Secondary	Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)	Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With AEs With Any and Related Medically Attended Visit	Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.	From Month 0 to Month 8 post-vaccination
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	Within 30 days (Days 0 - 29) after each vaccination
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	Occurrence and relationship to vaccination of all SAEs in all subjects. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)
Secondary	Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine	The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Fatal SAEs	Number of subjects with fatal SAEs during the entire study period were tabulated	During the entire study period (3 to 5 years following day 0)

External Links

•   IPD for this study will be made available via the Clinical Study Data Request site.