Last updated: 11/03/2018 10:54:15

Safety and immune response study of GSK Biologicals' influenza virus vaccine 1388442A compared with Fluarix

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GSK study ID
110127
See study documents
Clinicaltrials.gov ID
NCT00693706
See results summary
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: Safety and immunogenicity study of GSK Biologicals’ cell culture-based influenza virus vaccine 1388442A compared with US licensed TIV in healthy adults
Trial description: The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals’ cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with solicited local symptoms.

Timeframe: During the 7-day (Days 0-6) post vaccination period

Number of subjects with solicited general symptoms.

Timeframe: During the 7-day (Days 0-6) post vaccination period

Number of subjects with medically attended adverse events (MAEs).

Timeframe: During the entire study period (Days 0-182)

Number of subjects with new onset of chronic diseases (NOCDs).

Timeframe: During the entire study period (Days 0-182)

Number of subjects with unsolicited adverse events (AEs).

Timeframe: During the 90-day (Days 0-89) post-vaccination period

Number of subjects with serious adverse events (SAEs).

Timeframe: During the entire study period (Days 0-182)

Titers for serum Hemagglutination Inhibition (HI) antibodies for 3 strains of influenza disease.

Timeframe: At Day 21

Number of seroprotected subjects against 3 strains of influenza disease.

Timeframe: At Day 21

Number of seroconverted subjects against 3 strains of influenza disease.

Timeframe: At Day 21

Geometric mean fold-rise (GMFR) in 3 strains of influenza disease.

Timeframe: At Day 0 and Day 21

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Trivalent influenza vaccine GSK 138842A
  • Biological/vaccine: Fluarix
    • Enrollment:
    200
    Primary completion date:
    2009-26-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK1388442A, SB218352
    Collaborators
    Not applicable
    Study date(s)
    June 2008 to March 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 49 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes can and will comply with the requirements of the protocol
    • A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
    • Receipt of systemic glucocorticoids within 30 days of study enrollment
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who the investigator believes can and will comply with the requirements of the protocol
    • A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
    • Access to a telephone for scheduled follow-up telephone contacts
    • Ability to provide written informed consent
    • Healthy subjects as established by medical history and physical examination before entering into the study
    • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.
    Exclusion criteria:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
    • Receipt of systemic glucocorticoids within 30 days of study enrollment
    • Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
    • Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
    • Previous vaccination against influenza (2007-2008 influenza season)
    • History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
    • History of Guillain-Barre Syndrome (GBS)
    • Acute disease, febrile illness, or upper respiratory infection at screening.
    • History of splenectomy
    • Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination
    • Acquired or congenital coagulation disorders or known thrombocytopenia
    • Current treatment with warfarin or heparin derivatives
    • Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
    • Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33143
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lenexa, Kansas, United States, 66219
    Status
    Study Complete
    Contact us

    Study documents

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

    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
    2009-26-03
    Actual study completion date
    2009-26-03

    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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