Last updated: 07/14/2020 12:00:05

Study to evaluate the impact of reactogenicity on Quality of Life (QoL), after administration of GlaxoSmithKline (GSK) Biologicals’ candidate Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) in adults ≥ 50 years of age

GSK study ID
204928
Clinicaltrials.gov ID
EudraCT ID
Not applicable
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: Study to evaluate the impact of reactogenicity on Quality of Life (QoL), after administration of GSK Biologicals’ candidate Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) in adults ≥ 50 years of age
Trial description: The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals’ HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Change in the Short Form 36-item-health survey (SF36) Physical Functioning (PF) from baseline score to mean score after first dose

Timeframe: From Baseline at Day -7 to Day 8 after first dose

Secondary outcomes:

Change in mean SF-36 PF scale scores from baseline score to mean score after second dose

Timeframe: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

Change in mean SF-36 PF single item scores after first dose

Timeframe: From Baseline at Day -7 to Day 8 after first dose

Change in mean SF-36 PF single item scores after second dose

Timeframe: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

Change in SF-36 Role Physical scores after first dose

Timeframe: From Baseline at Day -7 to Day 8 after first dose

Change in SF-36 Role Physical scores after second dose

Timeframe: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

Change in Quality-adjusted life year (QALY) after first dose

Timeframe: From Baseline at Day -7 to Day 8 after first dose

Change in QALY after second dose

Timeframe: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

Number of reactogenicity-triggered medically attended visits after first dose

Timeframe: From Day 1 to Day 7 after first dose

Number of reactogenicity-triggered medically attended visits after second dose

Timeframe: From Day 1 to Day 7 after second dose

Days of work loss for subjects after first dose

Timeframe: From Day 1 to Day 7 after first dose

Days of work loss for subjects after second dose

Timeframe: From Day 1 to Day 7 after second dose

Days of work loss for non-dedicated caregivers after first dose

Timeframe: From Day 1 to Day 7 after first dose

Days of work loss for non-dedicated caregivers after second dose

Timeframe: From Day 1 to Day 7 after second dose

Days of extra work for dedicated caregivers after first dose

Timeframe: From Day 1 to Day 7 after first dose

Days of extra work for dedicated caregivers after second dose

Timeframe: From Day 1 to Day 7 after second dose

Number of subjects with any and grade 3 solicited local symptoms after first dose

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after first dose.

Number of subjects with any and grade 3 solicited local symptoms after second dose

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after second dose.

Number of days with solicited local symptoms after first dose

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after first dose.

Number of days with solicited local symptoms after second dose

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after second dose.

Number of subjects with any, grade 3 and related solicited general symptoms after first dose

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after first dose.

Number of Subjects With any, grade 3 and related solicited general symptoms after second dose

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after second dose.

Number of days with solicited general symptoms after first dose

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after first dose.

Number of days with solicited general symptoms after second dose

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after second dose.

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

Timeframe: During a 30-day follow-up period (Day 1 to Day 30) after any vaccination (across doses).

Number of subjects with any and related serious adverse events (SAEs) during the entire study period

Timeframe: From Day 1 to study end at Month 14

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

Timeframe: From Day 1 to study end at Month 14

Interventions:
  • Biological/vaccine: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
  • Enrollment:
    404
    Primary completion date:
    2017-12-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kenneth E Schmader, Myron J Levin, Katrijn Grupping, Sean Matthews, David Butuk, Michael Chen, Mohamed El Idrissi, Laurence A Fissette, Charles Fogarty, Paul Hartley, Nicola P Klein, Max Nevarez, Kari Uusinarkaus, Lidia Oostvogels, Desmond Curran. The impact of reactogenicity after the first dose of recombinant zoster vaccine upon the physical functioning and quality of life of older adults: an open phase III trial. J Gerontol A Biol Sci Med Sci. 2018.74(8):1217-1224.
    Desmond Curran, Melissa K. Andrew, Myron J. Levin, Elisa Turriani, Sean Matthews, Charles Fogarty, Nicola P. Klein, Katrijn Grupping, Lidia Oostvogels, Kenneth E. Schmader. Evaluation of Two Frailty Indices, with Practical Application in A Vaccine Clinical Trial. Hum Vaccin Immunother. 2019.15(12):2960-2968.
    Kenneth E. Schmader, Myron J. Levin, Michael Chen, Sean Matthews, Megan Riley, Wayne Woo, Caroline Hervé, Katrijn Grupping, Anne E. Schuind, Lidia Oostvogels, Desmond Curran. Impact of reactogenicity after two doses of recombinant zoster vaccine upon physical functioning and quality of life: an open phase III trial in older adults. J Gerontol A Biol Sci Med Sci. 2020. ePub.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    January 2017 to May 2018
    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 questionnaires and diary cards).
    • Written informed consent obtained from the subject prior to performance of any study specific procedure.
    • Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
    • Use or planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccine or current participation or planned concurrent participation in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device) during the period starting 30 days before the first dose of study vaccine and the study end.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Aurora, Colorado, United States, 80045
    Status
    Study Complete
    Location
    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80906
    Status
    Study Complete
    Location
    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80922
    Status
    Study Complete
    Location
    GSK Investigational Site
    Corvallis, Oregon, United States, 97330
    Status
    Study Complete
    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27705
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64114
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Protocol
    Available language(s): English
    Statistical analysis plan
    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
    2017-12-04
    Actual study completion date
    2018-24-05

    Plain language summaries

    Summary of results in plain language
    Available language(s): English

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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