Last updated: 07/17/2024 16:53:41

Study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) when co-administered with GSK Biologicals’ diphtheria, tetanus and pertussis vaccine (Boostrix®) in adults aged 50 years and older

GSK study ID
116887
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 Boostrix® 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 Boostrix® 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 a vaccine response for anti-glycoprotein E (anti-gE) in GSK1437173A Group

Timeframe: At 1 month post-Dose 2 (Month 3)

Antibody concentrations against glycoprotein E (anti-gE)

Timeframe: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)

Antibody concentrations against pertussis toxoid (anti-PT), filamentous hemagglutinin (anti-FHA) and pertactin (anti-PRN) antigens

Timeframe: At 1 month post-Dose 1 (Month 1)

Antibody concentrations against diphteria (anti-D) and tetanus (anti-T) antigens

Timeframe: At 1 month post-Dose 1 (Month 1)

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms, by dose

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any and Grade 3 solicited local symptoms, by study vaccine

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any, Grade 3 and related solicited general symptoms, by dose

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of days with solicited symptoms

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any and related potential Immune Mediated Diseases (pIMDs)

Timeframe: From first vaccination up to study end (Day 0 to Month 14)

Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)

Timeframe: Within the 30-day (Days 0-29) post-vaccination period

Number of subjects with any serious adverse events (SAEs)

Timeframe: From first vaccination up to study end (Day 0 to Month 14)

Interventions:
  • Biological/vaccine: Herpes Zoster vaccine GSK 1437173A
  • Biological/vaccine: Boostrix
  • Enrollment:
    903
    Primary completion date:
    2015-16-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Strezova A et al. (2019) The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial. Vaccine. 37(39):5877-5885.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A, SB776423
    Collaborators
    Not applicable
    Study date(s)
    February 2014 to April 2016
    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.
    • 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
    Charlotte, North Carolina, United States, 28209
    Status
    Study Complete
    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29650
    Status
    Study Complete
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89104
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lewiston, Maine, United States, 04240
    Status
    Study Complete
    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83712
    Status
    Study Complete
    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23294
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Protocol
    Available language(s): English
    Scientific result summary
    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
    2015-16-06
    Actual study completion date
    2016-21-04

    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

    Additional information
    Not applicable
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