Last updated: 11/03/2018 15:41:39

Study to evaluate the immunogenicity and safety of an investigational influenza (H1N1 influenza virus) vaccine in adults, using two different manufacturing processes

GSK study ID
113809
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: Immunological non-inferiority between two process-manufactured influenza vaccines in adults aged 18 to 60 years
Trial description: The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals’ investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects who were seroprotected for Haemagglutination Inhibition (HI) antibodies against the Flu A/California/7/2009 (H1N1) virus strain

Timeframe: At Day 21

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Day 21

Secondary outcomes:

Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

Timeframe: At Days 0 and 42

Titers for serum Hemagglutination Inhibition (HI) antibodies against Flu A/CAL/7/09 strain of influenza disease

Timeframe: At Days 0 and 42

Number of subjects who were seroprotected for Haemagglutination Inhibition (HI) antibodies against the Flu A/California/7/2009 (H1N1) virus strain

Timeframe: At Days 182 and 364

Titers for serum Hemagglutination Inhibition (HI) antibodies against Flu A/California/7/2009 strain of influenza disease

Timeframe: At Days 182 and 364

Number of Seroconverted (SCR) subjects for HI antibodies

Timeframe: At Days 21 and 42

Number of SCR subjects for HI antibodies

Timeframe: At Days 182 and 364

Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

Timeframe: At Days 0, 21 and 42

Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

Timeframe: At Days 182 and 364

Geometric mean fold rise (GMFR) for HI antibodies against Flu A/CAL/7/09 strain of influenza disease

Timeframe: At Days 21 and 42

Geometric mean fold rise (GMFR) for HI antibodies against Flu A/CAL/7/09 strain of influenza disease

Timeframe: At Days 182 and 364

Number of subjects with any and Grade 3 solicited local symptoms

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

Number of days with solicited local symptoms

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

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

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

Number of days with solicited general symptoms

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

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

Timeframe: During the entire study period (from Day 0 up to Day 364)

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

Timeframe: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (from Day 0 up to Day 364)

Interventions:
  • Biological/vaccine: GSK investigational vaccine GSK2340272A
  • Enrollment:
    300
    Primary completion date:
    2010-09-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK2340272A
    Collaborators
    Not applicable
    Study date(s)
    October 2009 to November 2010
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • All subjects must satisfy ALL the following criteria at study entry:
    • A male or female aged 18 to 60 years of age at the time of the first vaccination.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
    • Presence of evidence of substance abuse or 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04103
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01067
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01307
    Status
    Study Complete
    Location
    GSK Investigational Site
    Freiberg, Sachsen, Germany, 09599
    Status
    Study Complete

    Study documents

    Clinical study report
    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
    2010-09-11
    Actual study completion date
    2010-09-11

    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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