Study to evaluate immunogenicity and safety of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine at 9 and 10 years after vaccine administration and assessment of re-vaccination with 2 additional doses at 10 years after initial vaccination, in healthy subjects aged 60 years of age and older.

A phase IIIB, open, long term extension study to evaluate the persistence of immune responses and the safety of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine 1437173A, at Months 108 and 120 post-vaccination and the assessment of re-vaccination with two additional doses administered at 10 years after the initial vaccination in study Zoster-003 (NCT00434577) in healthy subjects aged 60 years of age and older. - ZOSTER-060 EXT:003

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004400-30-DE

Enrollment

100

Registered

2016-01-29

Start date

2016-04-07

Completion date

Unknown

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster (HZ) MedDRA version: 20.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: HLT Classification code 10019972 Term: Herpes viral infections System Organ Class: 100000005073 MedDRA version: 20.0 Level: HLGT Classification code 10047438 Term: Viral infectious disorders System Organ Class: 100000004862 MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and in

Interventions

Product Name: Herpes Zoster vaccine (GSK 1437173A) Product Code: HZ/su Pharmaceutical Form: Powder and suspension for suspension for injection INN or Proposed INN: - Current Sponsor code: gE Other des

Eligibility

Sex/Gender

All

Inclusion criteria

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 care-giver 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 prior to performance of any study specific procedure. • Previous participation in study ZOSTER-003 (NCT00434577), in group 50 µg gE / AS01B, and who completed the vaccination course (2 doses of HZ/su) in study ZOSTER-003 (NCT00434577). • Subjects are expected to enter the study (or complete Visit 1) as of the time they turn 108 months after first vaccination of previous vaccination course with HZ/su and not later than 111 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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 study visit (Day -29 to Day 0), or planned use during the study period. • Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of =20 mg/day [or equivalent]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection). • Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine* within 8 days prior to or within 14 days after either dose of study vaccine. *E.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines. • Previous vaccination against HZ since initial vaccination in Zoster-003. • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study start, or planned administration during the study period. • History of previous HZ.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate persistence of humoral and cell mediated immune responses overall at Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).;Secondary Objective: For the persistence phase Months 108 and 120 post first dose of initial vaccination in study Zoster-003 (NCT00434577): • To evaluate the persistence of humoral and cell mediated immune responses within each age cohort (60-69 YOA and =70 YOA at the time of the initial vaccination) at Months 108 and 120 post first dose of initial vaccination course. • To evaluate the safety of the study vaccine from Month 108 to Month 120 post first dose of initial vaccination course. For the re-vaccination phase: • To evaluate humoral and cell mediated immune responses to a two dose re-vaccination course at one month after each dose (Months 121 and 123) and 12 months after last dose (Month 134) when administered 10 years after the initial vaccination course. • To evaluate the reactogenicity and safety of the study vaccine after re-vaccination with two additional doses.;Primary end point(s): 1. Antigen-specific antibody (Ab) concentrations. - Anti-gE Ab concentrations as determined by ELISA 2. Cell-Mediated Immunity (CMI) in terms of frequencies of anti-gen-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(s) of evaluation of this end point: 1 and 2. At Month 108 and Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).	—

Measure

Time frame

Main Objective: • To evaluate persistence of humoral and cell mediated immune responses overall at Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).;Secondary Objective: For the persistence phase Months 108 and 120 post first dose of initial vaccination in study Zoster-003 (NCT00434577): • To evaluate the persistence of humoral and cell mediated immune responses within each age cohort (60-69 YOA and =70 YOA at the time of the initial vaccination) at Months 108 and 120 post first dose of initial vaccination course. • To evaluate the safety of the study vaccine from Month 108 to Month 120 post first dose of initial vaccination course. For the re-vaccination phase: • To evaluate humoral and cell mediated immune responses to a two dose re-vaccination course at one month after each dose (Months 121 and 123) and 12 months after last dose (Month 134) when administered 10 years after the initial vaccination course. • To evaluate the reactogenicity and safety of the study vaccine after re-vaccination with two additional doses.;Primary end point(s): 1. Antigen-specific antibody (Ab) concentrations. - Anti-gE Ab concentrations as determined by ELISA 2. Cell-Mediated Immunity (CMI) in terms of frequencies of anti-gen-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(s) of evaluation of this end point: 1 and 2. At Month 108 and Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Antigen-specific antibody (Ab) concentrations. - Anti-gE Ab concentrations as determined by ELISA within each age cohort (60-69 YOA and =70 YOA at the time of initial vaccination) 2. Cell-Mediated Immunity (CMI) in terms of frequencies of anti-gen-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) within each age cohort (60-69 YOA and = 70 YOA at the time of initial vaccination) 3. Occurrence of all serious adverse events (SAEs) related to study participation or to a concurrent GSK medication/vaccine (including HZ/su administered during the Zoster-003 (NCT00434577) study). - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. 4. Antigen-specific antibody (Ab) concentrations post re-vaccination. - Anti-gE antibody concentrations as determined by ELISA in all subjects 5. Cell-Mediated Immunity (CMI) in terms of frequencies of anti-gen-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) 6. Occurrence and intensity of each solicited local and general symptom in all subjects 7. Occurrence, intensity and relationship to vaccination of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects - 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 m	—

Measure

Time frame

Secondary end point(s): 1. Antigen-specific antibody (Ab) concentrations. - Anti-gE Ab concentrations as determined by ELISA within each age cohort (60-69 YOA and =70 YOA at the time of initial vaccination) 2. Cell-Mediated Immunity (CMI) in terms of frequencies of anti-gen-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) within each age cohort (60-69 YOA and = 70 YOA at the time of initial vaccination) 3. Occurrence of all serious adverse events (SAEs) related to study participation or to a concurrent GSK medication/vaccine (including HZ/su administered during the Zoster-003 (NCT00434577) study). - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. 4. Antigen-specific antibody (Ab) concentrations post re-vaccination. - Anti-gE antibody concentrations as determined by ELISA in all subjects 5. Cell-Mediated Immunity (CMI) in terms of frequencies of anti-gen-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) 6. Occurrence and intensity of each solicited local and general symptom in all subjects 7. Occurrence, intensity and relationship to vaccination of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects - 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 m

—

Countries

Czech Republic, Germany, Sweden

Contacts

Public ContactClinical Disclosure Advisor

GlaxoSmithKline Biologicals

GSKClinicalSupportHD@gsk.com442089904466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026