Last updated: 11/07/2018 06:22:19

Study to evaluate immunological equivalence between two investigational influenza vaccines in adults (H1N1)

GSK study ID
113535
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 equivalence between GSK2340272A and GSK2340274A influenza vaccines in adults aged 18 to 60 years
Trial description: The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals’ adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: At Day 21

Secondary outcomes:

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

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

Timeframe: At Days 0 and 42

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

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 across doses

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 across doses

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

Timeframe: From Day 0 up to Day 42

Number of subjects with pIMDs

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

Number of subjects with any adverse event of special interest (AESIs)

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 (Days 0 - 20) and 63 days after the second vaccination (up to 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: Influenza vaccine GSK2340272A
  • Biological/vaccine: Influenza vaccine GSK2340274A
  • Enrollment:
    336
    Primary completion date:
    2009-09-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Launay O et al. (2013) Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials. BMC Infect Dis. 13(435):1-11.
    Medical condition
    Influenza
    Product
    GSK2340272A, GSK2340274A
    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
    • Male or female aged 18 to 60 years inclusive, at the time of the first vaccination.
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
    • Use of any investigational or non-registered product 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
    Wuerzburg, Bayern, Germany, 97070
    Status
    Study Complete
    Location
    GSK Investigational Site
    Poitiers, France, 86000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris Cedex 18, France, 75877
    Status
    Study Complete
    Location
    GSK Investigational Site
    Regensburg, Bayern, Germany, 93053
    Status
    Study Complete
    Location
    GSK Investigational Site
    Schmiedeberg, Sachsen, Germany, 01762
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris, France, 75679
    Status
    Study Complete
    Showing 1 - 6 of 7 Results

    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
    2009-09-11
    Actual study completion date
    2010-04-11

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website