Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

Herpes Zoster Clinical Trial

Official title:

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165229
• Other study ID #: 113077
• Secondary ID: 2009-015791-94
• Status: Completed
• Phase: Phase 3
• Start date: August 2, 2010
• Est. completion date: July 24, 2015

Study information

• Verified date: April 2020
• 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 ≥ 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14819
• Est. completion date: July 24, 2015
• Est. primary completion date: July 24, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 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 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.

Related Conditions & MeSH terms

• Herpes Zoster
• Herpes Zoster Vaccine

Intervention

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

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Caboolture	Queensland
Australia	GSK Investigational Site	Geelong	Victoria
Australia	GSK Investigational Site	Glebe	New South Wales
Australia	GSK Investigational Site	Ivanhoe	Victoria
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	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
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Curitiba/Paraná	Paraná
Brazil	GSK Investigational Site	Curitiba/PR
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
Canada	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Gatineau	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Mirabel	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Quebec City	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois Rivières	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
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	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	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	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kyoto
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	Bucheon-si,
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	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	Eskilstuna
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Jönköping
Sweden	GSK Investigational Site	Karlskrona
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Skövde
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uppsala
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	Bangor
United Kingdom	GSK Investigational Site	Belfast
United Kingdom	GSK Investigational Site	Bradford on Avon	Wiltshire
United Kingdom	GSK Investigational Site	Broughshane
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Ledbury
United Kingdom	GSK Investigational Site	Newtonabbey
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 (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Number of Subjects With Post-herpetic Neuralgia (PHN)	PHN cases in the mTVc.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Days With Severe 'Worst' HZ-associated Pain	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 Zoster Brief Pain Inventory (ZBPI) 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 Mortality and Hospitalizations	The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Overall Mortality and HZ-related Mortality	The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Confirmed HZ Episode Related Hospitalizations	Incidence of overall and HZ-related hospitalizations during the study.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With HZ Related Complications	Incidence of HZ complications during the study in subjects with confirmed HZ.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects Receiving Pain Medication Associated With HZ	Incidence of use of pain medications throughout the study	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Days With Pain Medication Associated With HZ	Incidence of reduction of duration of pain medication associated with HZ throughout the study.	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	Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; 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 everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.	Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, 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 the 30 days (Days 0-29) after each vaccination
Secondary	Number of Subjects With Any and Related Serious Adverse Events (SAEs)	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.	From Month 0 to Month 14
Secondary	Number of Subjects With Fatal Serious Adverse Events (SAEs)	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.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication	The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated	During the entire study period (3 to 5 year period following day 0)
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) during the entire study period in all subjects	During the entire study period (3 to 5 year period following Day 0)
Secondary	Number of Subjects With Any and Related Medically Attended Visits	Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.	From Month 0 to Month 8 post-vaccination
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects = 50 YOA	Incidence of PHN calculated using the mTVc during the entire study period in subjects = 50 YOA.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects = 50 YOA With Confirmed HZ	Occurrence of PHN during the entire study period in all subjects with confirmed HZ.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects = 70 YOA With Confirmed HZ.	The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects = 70 YOA with confirmed HZ .	During the entire study period (3 to 5 year period following Day 0)
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects = 70 YOA With Confirmed HZ.	Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects = 70 YOA with confirmed HZ.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects = 70 YOA. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.	Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. 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 following each dose and across doses
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects = 70 YOA	Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects = 70 YOA.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	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs	Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects = 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.	From Month 0 to Month 14
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs	Fatal SAEs during the entire study period in subjects = 70 YOA.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs	Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects = 70 YOA.	During the entire study period (3 to 5 year period following Day 0)
Secondary	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits	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, from Month 0 to Month 8 in subjects = 70 YOA.	From Month 0 to Month 8 post-vaccination

External Links

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