Last updated: 11/07/2018 11:20:06

Study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ seasonal influenza vaccine GSK2321138A in adults aged 50 years and older

GSK study ID
117036
Clinicaltrials.gov ID
EudraCT ID
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: Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ seasonal influenza vaccine GSK2321138A in adults aged 50 years and older
Trial description: The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals’ HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with vaccine response to anti-gE antibodies

Timeframe: At one month post-dose 2 (Month 3)

Vaccine response for anti-gE humoral immunogenicity

Timeframe: At one month post-dose 2 (Month 3)

Adjusted geometric mean ELISA concentrations of anti-gE antibodies

Timeframe: At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)

FLU Haemagglutination inhibition (HI) antibody titers

Timeframe: At Day 21 post vaccination

Secondary outcomes:

Number of subjects with FLU HI antibody titers ≥1:10

Timeframe: At Day 0 (PRE) and 21 post vaccination

Number of seroprotected subjects with HI antibody titers ≥ 1:40

Timeframe: At Day 0 (PRE) and at Day 21 post vaccination

FLU Haemagglutination inhibition (HI) antibody titers

Timeframe: At Day 0 (PRE) and Day 21 post vaccination

Number of seroconverted subjects in terms of HI antibodies

Timeframe: At Day 21 post vaccination

Geometric mean ratio for Flu HI antibodies post-vaccination titer

Timeframe: At Day 21 post vaccination

Number of subjects with solicited local symptoms

Timeframe: Within 7 days (Days 0-6) after each vaccine dose

Number of subjects with solicited local symptoms

Timeframe: Within 7 days (Days 0-6) across doses

Number of subjects with solicited general symptoms

Timeframe: Within 7 days (Days 0-6) after each vaccine dose

Number of subjects with solicited general symptoms

Timeframe: Within 7 days (Days 0-6) after each vaccine dose

Number of subjects with solicited general symptoms

Timeframe: Within 7 days (Days 0-6) across doses

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During 30 days (Days 0-29) after vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: From first vaccination up to Month 18 (study end)

Number of subjects with potential immune-mediated diseases (pIMDs)

Timeframe: From first vaccination up to Month 18 (study end)

Interventions:
  • Biological/vaccine: Herpes Zoster vaccine GSK 1437173A
  • Biological/vaccine: GSK Biologicals’ quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A
  • Enrollment:
    829
    Primary completion date:
    2014-02-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Schwarz TF et al. (2017) Immunogenicity and safety of an adjuvanted Herpes Zoster Subunit Vaccine coadministered with seasonal influenza vaccine in adults aged 50 years or older. J Infect Dis. 216(11):1352-1361.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A, GSK2321138A
    Collaborators
    Not applicable
    Study date(s)
    October 2013 to March 2015
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    Yes
    • 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).
    • A male or female aged 50 years or older, at the time of the first vaccination with the study vaccine(s).
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Luebeck, Schleswig-Holstein, Germany, 23554
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13347
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wuerzburg, Bayern, Germany, 97070
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10717
    Status
    Study Complete
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M9W 4L6
    Status
    Study Complete
    Location
    GSK Investigational Site
    Freital, Sachsen, Germany, 01705
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English
    Protocol
    Available language(s): English

    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
    2014-02-06
    Actual study completion date
    2015-20-03

    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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