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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

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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
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Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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Utah
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Virginia
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Washington
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Minas Gerais
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Paraná
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Brazil
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Rio Grande Do Sul
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Brazil
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Curitiba/PR
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Brazil
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São Paulo
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Canada
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British Columbia
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Canada
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Quebec
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Czechia
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Brno
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Ceske Budejovice
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Czechia
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Hradec Kralove
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Tallinn
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Seinajoki
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Tampere
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Segré
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Tours
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Shatin
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Lazio
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Piemonte
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Fukuoka
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Kanagawa
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Kyoto
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Tokyo
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Korea, Republic of
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Ansan
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Bucheon-si,
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Korea, Republic of
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Incheon
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Korea, Republic of
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Kangnam-gu, Seoul
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Korea, Republic of
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Kangwon-do
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Morelos
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Mexico
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Durango
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Monterrey
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Spain
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Alcover( Tarragona)
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Balenyà (Barcelona)
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Barcelona
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Centelles
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Spain
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La Roca Del Valles (Barcelona)
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Peralada( Girona)
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Spain
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Valencia
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Spain
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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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Sweden
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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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Sweden
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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
Country [123] 0 0
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
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com


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 not provided in https://clinicaltrials.gov/study/NCT01165177