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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01610414




Registration number
NCT01610414
Ethics application status
Date submitted
31/05/2012
Date registered
4/06/2012
Date last updated
23/01/2018

Titles & IDs
Public title
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
Scientific title
Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A
Secondary ID [1] 0 0
2012-000138-20
Secondary ID [2] 0 0
115523
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 received 2 doses of the candidate HZ vaccine GSK 1437173A, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.

Placebo comparator: Placebo Group - Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.


Treatment: Other: Herpes Zoster vaccine GSK1437173A
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm

Treatment: Other: Placebo
2 doses administered IM in deltoid region of non-dominant arm
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) Episode
Timepoint [1] 0 0
From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
Secondary outcome [1] 0 0
Duration of 'Worst' HZ-associated Pain
Timepoint [1] 0 0
From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period
Secondary outcome [2] 0 0
Number of Subjects With Confirmed HZ-associated Complications
Timepoint [2] 0 0
From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
Secondary outcome [3] 0 0
Number of Subjects With Postherpetic Neuralgia (PHN)
Timepoint [3] 0 0
From Month 0 until study end (21 months median follow-up)
Secondary outcome [4] 0 0
Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects
Timepoint [4] 0 0
At Months 0, 1, 2, 13 and 25
Secondary outcome [5] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Timepoint [5] 0 0
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary outcome [6] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Timepoint [6] 0 0
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary outcome [7] 0 0
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Timepoint [7] 0 0
During the 30-day (Days 0-29) post-vaccination period
Secondary outcome [8] 0 0
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Timepoint [8] 0 0
From Month 0 up to 365 days post last vaccination
Secondary outcome [9] 0 0
Number of Subjects With Any Relapse
Timepoint [9] 0 0
From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
Secondary outcome [10] 0 0
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo
Timepoint [10] 0 0
From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
Secondary outcome [11] 0 0
Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination
Timepoint [11] 0 0
From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years)

Eligibility
Key inclusion criteria
Study entry (enrollment) occurs at the Pre-vaccination visit.

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* A male or female aged 18 years or older at the time of study entry.
* Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs.
* 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 with the study vaccine/placebo, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 12 months after completion of the vaccination series (i.e., until Month 13).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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/placebo, or planned use during the study period. However, the investigational use of a registered or non-registered product to treat the subject's underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed.
* Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
* Planned administration during the study of a HZ vaccine other than the study vaccine.
* Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
* Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV) expected to last more than 6 months after transplantation.
* Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo.
* HIV infection by clinical history.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).

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
13/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2017
Sample size
Target
Accrual to date
Final
1877
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [3] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [4] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [5] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [6] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [7] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [8] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [9] 0 0
GSK Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3002 - East Melbourne
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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Wisconsin
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Antwerpen
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Brugge
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Bruxelles
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Gent
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Hasselt
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Jette
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Leuven
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Hradec Kralove
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Olomouc
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Praha 10
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Tallinn
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Helsinki
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Tampere
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Finland
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Turku
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Clermont-Ferrand Cedex 1
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France
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Créteil cedex
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Grenoble cedex 9
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Marseille cedex 9
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France
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Montpellier cedex 5
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France
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Pessac cedex
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France
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Rouen cedex 1
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Baden-Wuerttemberg
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Bayern
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South Africa
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Western Province
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Groenkloof
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Moreleta Park, Pretoria
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Barcelona
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La Coruña
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León
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Madrid
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Majadahonda (Madrid)
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Spain
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Malaga
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Murcia (El Palmar)
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Murcia
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Oviedo
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Pozuelo De Alarcón/Madrid
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Santander
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Valencia
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Taoyuan Hsien
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Lanarkshire
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United Kingdom
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Wiltshire
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United Kingdom
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Bournemouth
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United Kingdom
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Cottingham
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United Kingdom
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Headington, Oxford
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United Kingdom
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Leeds
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United Kingdom
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Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01610414