Last updated: 11/07/2018 08:18:48

Study of long term immune responses and safety of the GSK Herpes Zoster vaccine in healthy subjects

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GSK study ID
114825
See study documents
Clinicaltrials.gov ID
NCT01295320
See results summary
EudraCT ID
2010-022248-19
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Long term immunogenicity and safety of GSK Biologicals’ Herpes Zoster vaccine 1437173A in healthy subjects
Trial description: The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.
This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.
The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells

Timeframe: Month 48

Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells

Timeframe: Month 60

Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells

Timeframe: Month 72

Antigen-specific antibody (Ab) concentrations

Timeframe: Month 48

Antigen-specific antibody (Ab) concentrations

Timeframe: Month 60

Antigen-specific antibody (Ab) concentrations

Timeframe: Month 72

Secondary outcomes:

Number of subjects with any serious adverse events (SAEs) related to the study participation

Timeframe: Month 48 to Month 72

Number of subjects with any SAEs related to previous vaccination and not already documented

Timeframe: Month 0 to Month 72

Number of subjects with any fatal SAEs

Timeframe: Month 48 to Month 72

Number of subjects with any suspected cases of HZ episodes

Timeframe: Month 48 to Month 72

Number of subjects with any suspected cases of HZ episodes following participation in 108494 study and its follow-ups (108516, 108518 and 108520) and not already documented

Timeframe: Month 48 to Month 72

Number of subjects and relationship to vaccination of any potential immune mediated diseases (pIMDs) following participation in 108494 study and its follow-ups (108516, 108518 and 108520) and not already documented

Timeframe: Month 48 to Month 72

Interventions:
  • Procedure/surgery: Blood sample
    • Enrollment:
    129
    Primary completion date:
    2013-20-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Chlibek R et al. (2016) Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults. Vaccine. 34(6):863-868.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    February 2011 to June 2013
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    60+ years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes can and will comply with the requirements of the protocol
    • Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
    • Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product or; 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
    • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes can and will comply with the requirements of the protocol

      • Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
      • Written informed consent obtained from the subject
    Exclusion criteria:

      Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product or; 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

      • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
      • Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577
      • Having received a vaccine against HZ any time after study end of study NCT00434577
      • Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    AMSTERDAM, Netherlands, 1018 WT
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Essen, Nordrhein-Westfalen, Germany, 45359
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30625
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wuerzburg, Bayern, Germany, 97070
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mannheim, Baden-Wuerttemberg, Germany, 68161
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Koeln, Nordrhein-Westfalen, Germany, 51069
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2013-20-06
    Actual study completion date
    2013-20-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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