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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02690207




Registration number
NCT02690207
Ethics application status
Date submitted
16/02/2016
Date registered
24/02/2016

Titles & IDs
Public title
Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.
Scientific title
Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies
Secondary ID [1] 0 0
2015-000965-30
Secondary ID [2] 0 0
204486
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

Experimental: HZ/su Group - Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm


Treatment: Other: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Timepoint [1] 0 0
During 30 days (Days 0-29) after any vaccination (across doses)
Primary outcome [2] 0 0
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Primary outcome [3] 0 0
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Timepoint [3] 0 0
From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Secondary outcome [1] 0 0
Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s)
Timepoint [1] 0 0
From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Eligibility
Key inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, follow-up contacts). Or subjects' Legally Acceptable Representative(s) [LAR(s)]/caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, availability for follow-up contacts).
* Written informed consent obtained from the subject/Legally Acceptable representative(s) [LAR(s)] of the subject prior to performing any study specific procedure. If the subjects is not capable of giving consent, his/her assent to participate should be obtained to the extent possible.
* Subject who previously participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of placebo.
* Female subjects of non-childbearing potential may be enrolled in the study.

* Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* 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 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.

* treatment period refers to vaccination days and the interval between them.
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 (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use up to 30 days post Dose 2.
* Previous vaccination against Varicella Zoster virus (VZV) or HZ.
* Planned administration of VZV or HZ vaccination during the study (including an investigational or non-registered vaccine), with the exception of the study vaccine.
* Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant for seasonal or pandemic flus). These may be administered up to 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose and up to 30 days post Dose 2. For corticosteroids, this will mean prednisone = 20 mg/day or equivalent. Inhaled, topical and intra-articular corticosteroids are allowed.
* Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab) within six months prior to the first vaccine dose up to 30 days post Dose 2.
* Concurrently participating in another clinical study, at the time of enrolment or planned participation up to the 30 days post second dose, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, Human Immunodeficiency Virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Active HZ infection at the time of enrolment (i.e. HZ lesions not completely crusted over).
* Pregnant or lactating female.
* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
* Any condition which in the judgment of the investigator would make intramuscular injection unsafe.

Study design
Purpose of the study
Prevention
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
16/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2019
Sample size
Target
Accrual to date
Final
8687
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Maroubra
Recruitment hospital [2] 0 0
GSK Investigational Site - Umina
Recruitment hospital [3] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [4] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [5] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [7] 0 0
GSK Investigational Site - Ivanhoe
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2257 - Umina
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
2522 - Wollongong
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3079 - Ivanhoe
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Florida
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Idaho
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Kansas
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Maryland
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Missouri
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Nevada
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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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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Brazil
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Minas Gerais
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Brazil
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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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Czechia
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Ceske Budejovice
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Czechia
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Hradec Kralove
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Estonia
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Tallinn
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Tartu
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Finland
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Espoo
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Helsinki
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Finland
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Jarvenpaa
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Finland
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Kokkola
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Finland
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Oulu
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Pori
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Finland
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Seinajoki
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Finland
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Tampere
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Finland
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Turku
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France
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Angers
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France
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Château Gontier
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France
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Clermont-Ferrand
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France
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Laval
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France
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Montrevault
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France
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Muret
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France
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Murs-Erigne
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France
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Nantes
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France
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Rosiers d'Egletons
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France
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Saint Cyr sur Loire
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France
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Segré
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France
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Tours
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Magdeburg
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Hong Kong
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Kwun Tong
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Hong Kong
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Shatin
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Italy
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Abruzzo
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Sardegna
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Italy
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Sicilia
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Japan
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Fukuoka
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Japan
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Kanagawa
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Japan
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Tokyo
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Korea, Republic of
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Ansan
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Korea, Republic of
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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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Mexico
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Morelos
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Mexico
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Nuevo León
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Mexico
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Durango
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Spain
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Alcover( Tarragona)
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Spain
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Balenyà (Barcelona)
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Spain
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Barcelona
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Spain
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Centelles (Barcelona)
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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( Madrid
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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
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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
State/province [101] 0 0
Göteborg
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Sweden
State/province [102] 0 0
Jönköping
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Sweden
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Karlskrona
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Sweden
State/province [104] 0 0
Linköping
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Sweden
State/province [105] 0 0
Malmö
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Sweden
State/province [106] 0 0
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
Country [113] 0 0
Taiwan
State/province [113] 0 0
Taoyuan
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Lancashire
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Warwickshire
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Wiltshire
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United Kingdom
State/province [117] 0 0
Bangor
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Belfast
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Broughshane
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Liverpool
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Newtonabbey

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 is 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 (copy the URL below to your browser)
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/Posting.aspx?ID=20772


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02690207