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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01165177




Registration number
NCT01165177
Ethics application status
Date submitted
15/07/2010
Date registered
19/07/2010
Date last updated
10/02/2021

Titles & IDs
Public title
Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older
Scientific title
Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Secondary ID [1] 0 0
2008-000367-42
Secondary ID [2] 0 0
110390
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Herpes Zoster Vaccine GSK1437173A
Treatment: Other - Placebo

Experimental: GSK1437173A group - Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule

Placebo comparator: Placebo group - Subjects will receive NaCl solution placebo according to a 0, 2-month schedule


Treatment: Other: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection

Treatment: Other: Placebo
Intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
Timepoint [1] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [1] 0 0
Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)
Timepoint [1] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [2] 0 0
Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain
Timepoint [2] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [3] 0 0
Number of Subjects With Confirmed HZ Episode Related Mortality
Timepoint [3] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [4] 0 0
Number of Subjects With HZ Related Complications
Timepoint [4] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [5] 0 0
Number of Subjects With Confirmed HZ Episode Related Hospitalizations
Timepoint [5] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [6] 0 0
Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ
Timepoint [6] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [7] 0 0
Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ
Timepoint [7] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [8] 0 0
Number of Days With Severe 'Worst' HZ-associated Pain.
Timepoint [8] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [9] 0 0
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
Timepoint [9] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [10] 0 0
Number of Subjects With HZ Related Complications, by Complication Type
Timepoint [10] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [11] 0 0
Distribution of Pain Medication Associated With HZ
Timepoint [11] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [12] 0 0
Number of Days of Pain Medication Associated With HZ
Timepoint [12] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [13] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Timepoint [13] 0 0
During the 7-day (Days 0-6) post-vaccination period
Secondary outcome [14] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Timepoint [14] 0 0
Within the 7-day (Days 0-6) post-vaccination period
Secondary outcome [15] 0 0
Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)
Timepoint [15] 0 0
Within the 7-day (Days 0-6) post-vaccination period
Secondary outcome [16] 0 0
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Timepoint [16] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [17] 0 0
Number of Subjects With AEs With Any and Related Medically Attended Visit
Timepoint [17] 0 0
From Month 0 to Month 8 post-vaccination
Secondary outcome [18] 0 0
Number of Subjects With Unsolicited Adverse Events (AEs)
Timepoint [18] 0 0
Within 30 days (Days 0 - 29) after each vaccination
Secondary outcome [19] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [19] 0 0
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 outcome [20] 0 0
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
Timepoint [20] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [21] 0 0
Number of Subjects With Fatal SAEs
Timepoint [21] 0 0
During the entire study period (3 to 5 years following day 0)

Eligibility
Key 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;
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/07/2015
Sample size
Target
Accrual to date
Final
16165
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Glebe
Recruitment hospital [2] 0 0
GSK Investigational Site - Maroubra
Recruitment hospital [3] 0 0
GSK Investigational Site - Umina
Recruitment hospital [4] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [5] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [6] 0 0
GSK Investigational Site - Sherwood
Recruitment hospital [7] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [8] 0 0
GSK Investigational Site - Ivanhoe
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
2257 - Umina
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
2522 - Wollongong
Recruitment postcode(s) [6] 0 0
4075 - Sherwood
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3079 - Ivanhoe
Recruitment outside Australia
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United States of America
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Incheon
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Kangnam-gu, Seoul
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Peralada( Girona)
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Valencia
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Vic/ Barcelona
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Sweden
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Borås
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Sweden
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Eskilstuna
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Göteborg
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Sweden
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Jönköping
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Sweden
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Karlskrona
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Linköping
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Sweden
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Malmö
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Sweden
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Skövde
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Sweden
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Stockholm
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Sweden
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Uppsala
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Sweden
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Vällingby
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Sweden
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Örebro
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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Lancashire
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United Kingdom
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Warwickshire
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United Kingdom
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Wiltshire
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United Kingdom
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Bangor
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United Kingdom
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Belfast
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United Kingdom
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Broughshane
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United Kingdom
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Ledbury
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United Kingdom
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Newtonabbey
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Waterloo, Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01165177
Trial related presentations / publications
Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera 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.
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.
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.
Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barbera 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.
Carryn S, Cheuvart B, Povey M, Dagnew AF, Harpaz R, van der Most R, Casabona G. No Consistent Evidence of Decreased Exposure to Varicella-Zoster Virus Among Older Adults in Countries with Universal Varicella Vaccination. J Infect Dis. 2022 Feb 1;225(3):413-421. doi: 10.1093/infdis/jiab500.
Kim JH, Diaz-Decaro J, Jiang N, Hwang SJ, Choo EJ, Co M, Hastie A, Hui DSC, Irimajiri J, Lee J, Leung EM, Tang H, Tsuru T, Watson P, Wu Z, Yu CJ, Yuan Y, Zahaf T, Cunningham AL, Schuind A. The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults >/= 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials. Hum Vaccin Immunother. 2021 Jul 3;17(7):2050-2057. doi: 10.1080/21645515.2020.1859321. Epub 2021 Feb 19.
Dagnew AF, Rausch D, Herve C, Zahaf T, Levin MJ, Schuind A; ZOE-50/70 study group. Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials. Rheumatology (Oxford). 2021 Mar 2;60(3):1226-1233. doi: 10.1093/rheumatology/keaa424.
Colindres R, Wascotte V, Brecx A, Clarke C, Herve C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, Cunningham AL. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29.
Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, Schuind A; ZOE 50/70 study groups. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16.
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Public notes

Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01165177