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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02690207
Ethics application status
Date submitted
16/02/2016
Date registered
24/02/2016
Date last updated
12/03/2020

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - 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


Other interventions: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) - 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. 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.
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) - Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related=SAE assessed by the investigator as related to the vaccination.
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) - pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs=pIMDs assessed by the investigator as related to the vaccination.
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) - A suspected case of HZ was defined as a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations).
Clinically confirmed HZ episode is suspected HZ episode confirmed by the Investigator/Delegate.
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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [1] 0 0
Arizona
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United States of America
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California
Country [3] 0 0
United States of America
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Florida
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Idaho
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United States of America
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Kansas
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United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
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Missouri
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United States of America
State/province [8] 0 0
Nevada
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United States of America
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New Jersey
Country [10] 0 0
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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State/province [14] 0 0
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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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
State/province [24] 0 0
British Columbia
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Canada
State/province [25] 0 0
Newfoundland and Labrador
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Canada
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Nova Scotia
Country [27] 0 0
Canada
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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
State/province [31] 0 0
Hradec Kralove
Country [32] 0 0
Estonia
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Tallinn
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Estonia
State/province [33] 0 0
Tartu
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Finland
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Espoo
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Finland
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Helsinki
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Finland
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Jarvenpaa
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Finland
State/province [37] 0 0
Kokkola
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Finland
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Oulu
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Finland
State/province [39] 0 0
Pori
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Finland
State/province [40] 0 0
Seinajoki
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Finland
State/province [41] 0 0
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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Château Gontier
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Clermont-Ferrand
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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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Rosiers d'Egletons
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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
Country [59] 0 0
Germany
State/province [59] 0 0
Nordrhein-Westfalen
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Germany
State/province [60] 0 0
Rheinland-Pfalz
Country [61] 0 0
Germany
State/province [61] 0 0
Sachsen-Anhalt
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Germany
State/province [62] 0 0
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
Country [70] 0 0
Italy
State/province [70] 0 0
Lazio
Country [71] 0 0
Italy
State/province [71] 0 0
Liguria
Country [72] 0 0
Italy
State/province [72] 0 0
Lombardia
Country [73] 0 0
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
Country [88] 0 0
Mexico
State/province [88] 0 0
Durango
Country [89] 0 0
Spain
State/province [89] 0 0
Alcover( Tarragona)
Country [90] 0 0
Spain
State/province [90] 0 0
Balenyà (Barcelona)
Country [91] 0 0
Spain
State/province [91] 0 0
Barcelona
Country [92] 0 0
Spain
State/province [92] 0 0
Centelles (Barcelona)
Country [93] 0 0
Spain
State/province [93] 0 0
La Roca Del Valles (Barcelona)
Country [94] 0 0
Spain
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Madrid
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Spain
State/province [95] 0 0
Majadahonda( Madrid
Country [96] 0 0
Spain
State/province [96] 0 0
Peralada( Girona)
Country [97] 0 0
Spain
State/province [97] 0 0
Valencia
Country [98] 0 0
Spain
State/province [98] 0 0
Vic
Country [99] 0 0
Sweden
State/province [99] 0 0
Borås
Country [100] 0 0
Sweden
State/province [100] 0 0
Eskilstuna
Country [101] 0 0
Sweden
State/province [101] 0 0
Göteborg
Country [102] 0 0
Sweden
State/province [102] 0 0
Jönköping
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Sweden
State/province [103] 0 0
Karlskrona
Country [104] 0 0
Sweden
State/province [104] 0 0
Linköping
Country [105] 0 0
Sweden
State/province [105] 0 0
Malmö
Country [106] 0 0
Sweden
State/province [106] 0 0
Skövde
Country [107] 0 0
Sweden
State/province [107] 0 0
Stockholm
Country [108] 0 0
Sweden
State/province [108] 0 0
Uppsala
Country [109] 0 0
Sweden
State/province [109] 0 0
Vällingby
Country [110] 0 0
Sweden
State/province [110] 0 0
Örebro
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taichung
Country [112] 0 0
Taiwan
State/province [112] 0 0
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
Country [117] 0 0
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
The purpose of this study is to cross-vaccinate and collect safety data in terms of
unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated
Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in
ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).
Trial website
https://clinicaltrials.gov/show/NCT02690207
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

Summary results
Other publications