Last updated: 06/26/2019 11:10:24

Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ influenza vaccine(s) GSK3206641A and GSK3206640A administered in adults 18 to 64 years of age

GSK study ID
201072
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: An observer-blind study to evaluate the safety and immunogenicity of GSK Biologicals’ influenza vaccine(s) GSK3206641A and GSK3206640A administered in adults 18 to 64 years of age
Trial description: The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals’ H7N9 influenza vaccine in subjects 18 to 64 years of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

Timeframe: At Day 42

Occurrence of each solicited local symptom

Timeframe: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination

Occurrence of each solicited general symptom

Timeframe: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 0 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 7 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 21 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 28 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Timeframe: At Day 42 visit

Occurrence of unsolicited adverse events

Timeframe: 21 days after each dose

Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)

Timeframe: From Day 0 until the Day 42

Secondary outcomes:

Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

Timeframe: At Day 42

Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

Timeframe: At Day 42

Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers

Timeframe: GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 (Placebo group only) and Months 6 and 12; SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12

Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum

Timeframe: GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 and Months 6 and 12

Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers

Timeframe: GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6; VRR at Days 21, 42 and Month 6

Occurrence of MAEs, pIMDs and SAEs

Timeframe: Until the Month 12 visit

Interventions:
  • Biological/vaccine: Investigational H7N9 vaccine GSK3206641A
  • Biological/vaccine: Investigational H7N9 vaccine GSK3206640A
  • Biological/vaccine: Placebo
  • Enrollment:
    424
    Primary completion date:
    2014-01-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Madan A et al. (2016) Immunogenicity and safety of an AS03-adjuvanted H7N9 pandemic influenza vaccine in a randomised trial in healthy adults. J Infect Dis. pii: jiw414. [Epub ahead of print].
    Medical condition
    Influenza
    Product
    GSK3206640A, GSK3206641A
    Collaborators
    Not applicable
    Study date(s)
    November 2013 to January 2015
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    Yes
    • Male or female adults who are 18 to 64 years of age (inclusive) at the time of first study vaccination.
    • Written informed consent obtained from subject.
    • Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
    • Presence or evidence of substance abuse.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83642
    Status
    Study Complete
    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16506
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32216
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98105
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 2G2
    Status
    Study Complete
    Location
    GSK Investigational Site
    Stockbridge, Georgia, United States, 30281
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2014-01-02
    Actual study completion date
    2015-19-01

    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

    Participate in clinical trial
    Additional information
    Results for study 201072 can be found on the GSK Clinical Study Register
    Click here
    Access to clinical trial data by researchers
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