Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02723773




Registration number
NCT02723773
Ethics application status
Date submitted
10/03/2016
Date registered
30/03/2016
Date last updated
4/10/2019

Titles & IDs
Public title
A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults
Scientific title
Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults
Secondary ID [1] 0 0
2015-001778-17
Secondary ID [2] 0 0
201190
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: LTFU Group - Long-Term Follow-Up of the subjects who received at least one dose of the HZ/su vaccine in the primary studies ZOSTER-006/022

Experimental: Additional Dose Group (1AdD Group) - Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive 1 additional dose of the HZ/su vaccine in the current study.

Experimental: Revaccination Group (Rev Group) - Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive 2 additional doses of the HZ/su vaccine in the current study on a 0, 2 Month schedule (N=60).

Sham Comparator: Control Group (Ctrl Group) - Subjects who received 2 doses of the HZ/su vaccine in the primary studies ZOSTER-006/022 and will receive no additional doses of the HZ/su vaccine in the current study and will control for the 1-Additional and Revaccination groups


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 confirmed herpes zoster (HZ).cases - A suspected case of HZ can be confirmed in two ways:
By Polymerase Chain Reaction (PCR)
By the HZ Ascertainment Committee (HZAC)
Timepoint [1] 0 0
During the entire study period (up to Month 72).
Secondary outcome [1] 0 0
Number of subjects with confirmed herpes zoster (HZ) cases - A suspected case of HZ can be confirmed in two ways:
By Polymerase Chain Reaction (PCR)
By the HZ Ascertainment Committee (HZAC)
Timepoint [1] 0 0
1 month post dose 2 in the previous Z-006/022 studies to study end (Month 72).
Secondary outcome [2] 0 0
Number of subjects with confirmed post herpetic neuralgia (PHN) cases - PHN is defined by the presence of HZ-associated severe 'worst' pain persisting or appearing more than 90 days after onset of the HZ rash.
Timepoint [2] 0 0
1 month post dose 2 in the previous Z-006/022 studies to study end (Month 72).
Secondary outcome [3] 0 0
Number of HZ related complications (other than PHN) - HZ complications include: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke.
Timepoint [3] 0 0
For the total duration of the Zoster-049 study, i.e. from Month 1 post dose 2 in the previous Z-006/022 studies to study end (Month 72).
Secondary outcome [4] 0 0
Anti-glicoprotein E (gE) antibody (Ab) concentrations - Anti-gE Ab concentrations were expressed as geometric mean concentrations (GMCs), as determined by ELISA.
Timepoint [4] 0 0
At Months 0, 12, 24, 36, 48, 60 and 72 (LTFU Haemagglutination Inhibition(HI) subset, 1-Additional Dose, Revaccination and Control groups), at Month 1 (1-Additional Dose, Revaccination and Control groups), and at Month 3 (Revaccination and Control groups
Secondary outcome [5] 0 0
Cell mediated immunity (CMI) in terms of frequencies of antigen-specific CD4+ T cells. - Frequencies of CD4+ T cells with antigen-specific Interferon gamma (IFN-?) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-a) and/or CD40 Ligand (CD40L) secretion/expression to gE as determined by Intracellular Cytokine Staining (ICS).
Timepoint [5] 0 0
At Months 0, 12, 24, 36, 48, 60 and 72 (LTFU CMI subset, 1-Additional Dose, Revaccination and Control groups), at Month 1 (1-Additional Dose, Revaccination and Control groups), and at Month 3 (Revaccination and Control groups).
Secondary outcome [6] 0 0
Number of subjects with any, and Grade 3 solicited local symptoms - These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Timepoint [6] 0 0
Within 7 days (Days 0-6) after each vaccination.
Secondary outcome [7] 0 0
Number of subjects with any, Grade 3 and related solicited general symptoms - These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms,headache, myalgia, and shivering.Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Timepoint [7] 0 0
Within 7 days (Days 0-6) after each vaccination.
Secondary outcome [8] 0 0
Number of subjects with unsolicited adverse events (AEs) - These symptoms were assessed in subjects administered with 1 or 2 additional doses of HZ/su vaccine. 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Timepoint [8] 0 0
During the 30 days (Days 0-29) after each vaccination.
Secondary outcome [9] 0 0
Number of subjects with any Serious adverse events (SAEs) - SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Timepoint [9] 0 0
From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month 0 until 12 months after last HZ/su vaccination (Revaccination group).
Secondary outcome [10] 0 0
Number of subjects with any SAEs related to investigational vaccine, related to study participation or to GSK concomitant medica-tion/vaccine. - SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Timepoint [10] 0 0
During the entire study (up to Month 72)
Secondary outcome [11] 0 0
Number of subjects with any and related Potential immune-mediated diseases (pIMDs). - Potential immune-mediated diseases (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
Timepoint [11] 0 0
From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month until 12 months after last HZ/su vaccination (Revaccination group).

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, return for
follow-up visits, ability to have scheduled contacts to allow evaluation during the
study). Or subjects with a 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, availability for follow-up contacts).

- Written informed consent obtained from the subject prior to performance of any study
specific procedure.

- Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one
dose of HZ/su vaccine.

Additional inclusion criteria for the 1-Additional Dose Revaccination and Control groups,
ONLY:

- Female subjects of non-childbearing potential may be enrolled in this 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 this 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.
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 (pharmaceutical product or
device) at the time of enrolment or planned use during the study period.

- Previous vaccination against Varicella Zoster Virus (VZV) or HZ and/or planned
administration during the study of a VZV or HZ vaccine (including an investigational
or non-registered vaccine other than the HZ/su vaccine administered in studies
ZOSTER-006/022).

- Chronic administration (defined as = 14 consecutive days in total) of
immunosuppressants or other immune-modifying drugs during the period starting six
months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any
time during the study period. For corticosteroids, this will mean prednisone = 20
mg/day or equivalent. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical
and intra-articular corticosteroids are allowed.

- Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab)
within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration
at any time during the study period.

- 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).

- Administration of immunoglobulins and/or any blood products within 3 months prior to
Visit Month 0 of study ZOSTER-049 or planned administration during the study period.

- Prolonged use (> 14 consecutive days) of oral and/or parenteral antiviral agents that
are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be
used during the study period for an indication other than to treat suspected or
confirmed HZ or an HZ-related complication (topical use of these antiviral agents is
allowed).

- Important underlying illness that in the opinion of the investigator would be expected
to interfere significantly during the study.

Additional exclusion criteria for the 1-Additional Dose Revaccination and Control groups,
only:

- Subjects who experienced an SAE from first vaccination in the previous ZOSTER-006/022
studies to enrolment in study ZOSTER-049 that was considered related to study vaccine
by either the investigator or the sponsor.

- Subjects with a new onset of a pIMD or exacerbation of a pIMD from first vaccination
in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049.

- Use of any investigational or non-registered product (pharmaceutical product or
device) within 30 days preceding the first dose of study vaccine or planned use during
the study period.

- Administration or planned administration of any other immunizations within 30 days
before the first study vaccination or scheduled within 30 days after study
vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit
vaccines, including inactivated and subunit influenza vaccines for seasonal or
pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each
dose and/or at least 14 days after any dose of study vaccine.

- 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 (such as materials that may possibly contain
latex-gloves, syringes, etc.). Please note, the vaccine and vials in this study do not
contain latex.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions (if of childbearing potential).

- Previous episode/history of HZ.

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



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [2] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [3] 0 0
GSK Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
2522 - Wollongong
Recruitment postcode(s) [3] 0 0
3220 - Geelong
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
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Brazil
State/province [14] 0 0
Minas Gerais
Country [15] 0 0
Brazil
State/province [15] 0 0
Paraná
Country [16] 0 0
Brazil
State/province [16] 0 0
Curitiba/PR
Country [17] 0 0
Brazil
State/province [17] 0 0
São Paulo
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Czechia
State/province [22] 0 0
Brno
Country [23] 0 0
Czechia
State/province [23] 0 0
Ceske Budejovice
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Estonia
State/province [25] 0 0
Tallinn
Country [26] 0 0
Estonia
State/province [26] 0 0
Tartu
Country [27] 0 0
Finland
State/province [27] 0 0
Espoo
Country [28] 0 0
Finland
State/province [28] 0 0
Helsinki
Country [29] 0 0
Finland
State/province [29] 0 0
Jarvenpaa
Country [30] 0 0
Finland
State/province [30] 0 0
Kokkola
Country [31] 0 0
Finland
State/province [31] 0 0
Oulu
Country [32] 0 0
Finland
State/province [32] 0 0
Pori
Country [33] 0 0
Finland
State/province [33] 0 0
Seinajoki
Country [34] 0 0
Finland
State/province [34] 0 0
Tampere
Country [35] 0 0
Finland
State/province [35] 0 0
Turku
Country [36] 0 0
France
State/province [36] 0 0
Angers
Country [37] 0 0
France
State/province [37] 0 0
Château Gontier
Country [38] 0 0
France
State/province [38] 0 0
Clermont-Ferrand
Country [39] 0 0
France
State/province [39] 0 0
Laval
Country [40] 0 0
France
State/province [40] 0 0
Montrevault
Country [41] 0 0
France
State/province [41] 0 0
Muret
Country [42] 0 0
France
State/province [42] 0 0
Murs-Erigne
Country [43] 0 0
France
State/province [43] 0 0
Nantes
Country [44] 0 0
France
State/province [44] 0 0
Rosiers d'Egletons
Country [45] 0 0
France
State/province [45] 0 0
Segré
Country [46] 0 0
France
State/province [46] 0 0
Tours
Country [47] 0 0
Germany
State/province [47] 0 0
Baden-Wuerttemberg
Country [48] 0 0
Germany
State/province [48] 0 0
Bayern
Country [49] 0 0
Germany
State/province [49] 0 0
Hessen
Country [50] 0 0
Germany
State/province [50] 0 0
Nordrhein-Westfalen
Country [51] 0 0
Germany
State/province [51] 0 0
Rheinland-Pfalz
Country [52] 0 0
Germany
State/province [52] 0 0
Sachsen-Anhalt
Country [53] 0 0
Germany
State/province [53] 0 0
Sachsen
Country [54] 0 0
Germany
State/province [54] 0 0
Schleswig-Holstein
Country [55] 0 0
Germany
State/province [55] 0 0
Berlin
Country [56] 0 0
Germany
State/province [56] 0 0
Hamburg
Country [57] 0 0
Hong Kong
State/province [57] 0 0
Kwun Tong
Country [58] 0 0
Hong Kong
State/province [58] 0 0
Shatin
Country [59] 0 0
Italy
State/province [59] 0 0
Abruzzo
Country [60] 0 0
Italy
State/province [60] 0 0
Lazio
Country [61] 0 0
Italy
State/province [61] 0 0
Liguria
Country [62] 0 0
Italy
State/province [62] 0 0
Lombardia
Country [63] 0 0
Italy
State/province [63] 0 0
Sardegna
Country [64] 0 0
Japan
State/province [64] 0 0
Fukuoka
Country [65] 0 0
Japan
State/province [65] 0 0
Kanagawa
Country [66] 0 0
Japan
State/province [66] 0 0
Tokyo
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Ansan
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Bucheon-si,
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Incheon
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Kangwon-do
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Seoul
Country [72] 0 0
Mexico
State/province [72] 0 0
Jalisco
Country [73] 0 0
Mexico
State/province [73] 0 0
Durango
Country [74] 0 0
Spain
State/province [74] 0 0
Alcover( Tarragona)
Country [75] 0 0
Spain
State/province [75] 0 0
Balenyà (Barcelona)
Country [76] 0 0
Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
State/province [77] 0 0
Centelles (Barcelona)
Country [78] 0 0
Spain
State/province [78] 0 0
La Roca Del Valles (Barcelona)
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Majadahonda( Madrid
Country [81] 0 0
Spain
State/province [81] 0 0
Peralada( Girona)
Country [82] 0 0
Spain
State/province [82] 0 0
Valencia
Country [83] 0 0
Spain
State/province [83] 0 0
Vic
Country [84] 0 0
Sweden
State/province [84] 0 0
Borås
Country [85] 0 0
Sweden
State/province [85] 0 0
Eskilstuna
Country [86] 0 0
Sweden
State/province [86] 0 0
Göteborg
Country [87] 0 0
Sweden
State/province [87] 0 0
Jönköping
Country [88] 0 0
Sweden
State/province [88] 0 0
Karlskrona
Country [89] 0 0
Sweden
State/province [89] 0 0
Linköping
Country [90] 0 0
Sweden
State/province [90] 0 0
Malmö
Country [91] 0 0
Sweden
State/province [91] 0 0
Stockholm
Country [92] 0 0
Sweden
State/province [92] 0 0
Uppsala
Country [93] 0 0
Sweden
State/province [93] 0 0
Vällingby
Country [94] 0 0
Sweden
State/province [94] 0 0
Örebro
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taichung
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taipei City
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taipei
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taoyuan County
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Lancashire
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Warwickshire
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Wiltshire
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Belfast
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Broughshane

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 a long-term follow-up of the two studies 110390 and 113077
(ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK
Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2
additional doses in two subgroups of older adults.
Trial website
https://clinicaltrials.gov/show/NCT02723773
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