Last updated: 11/07/2018 02:50:34

Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

GSK study ID
110028
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: A Phase I/II, Observer-Blind, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Two-Dose Series of GSK Biologicals' Candidate Influenza Vaccine GSK 1557484A Antigens With or Without Adjuvant
Trial description: The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of seroconverted subjects against the A/Indonesia/5/2005 (H5N1) strain of influenza disease.

Timeframe: At Day 42

Titers for serum hemagglutination inhibition (HI) antibodies against the A/Indonesia/5/2005 (H5N1) strain of influenza disease.

Timeframe: At Day 42

Number of seroprotected subjects against the A/Indonesia/5/2005 (H5N1) strain of influenza disease.

Timeframe: At Day 42

Number of subjects with solicited local symptoms.

Timeframe: Within the 7-day follow-up period (Days 0-6) after any vaccination

Number of subjects with solicited general symptoms.

Timeframe: Within the 7-day follow-up period (Days 0-6) after any vaccination

Number of subjects with medically attended adverse events (MAEs) and new onset chronic diseases (NOCDs).

Timeframe: From Day 0 to 182

Number of subjects with unsolicited adverse events (AEs).

Timeframe: During the 21-day follow-up period (Days 0-20) after vaccination.

Number of subjects with unsolicited adverse events (AEs).

Timeframe: Between Day 0 and Day 84 after vaccination.

Number of subjects with any serious adverse events (SAEs).

Timeframe: From Day 0 to 182

Secondary outcomes:

Titers for serum HI antibodies against the A/Indonesia/5/2005 (H5N1) strain of influenza disease.

Timeframe: At Day 21 and Day 182

Number of seroconverted subjects against the A/Indonesia/5/2005 (H5N1) strain of influenza disease.

Timeframe: At Days 21 and 182

Geometric mean fold-rise (GMFR) against the A/Indonesia/5/2005 (H5N1) strain of influenza disease.

Timeframe: At Days 21 and 182

Number of seroprotected subjects against the A/Indonesia/5/2005 (H5N1) strain of influenza disease.

Timeframe: At Days 0, 21 and 182

Interventions:
  • Biological/vaccine: Pumarix™
  • Biological/vaccine: Pandemrix ™
  • Enrollment:
    780
    Primary completion date:
    2008-17-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Langley JM et al. (2010) Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults. J Infect Dis. 201(11):1644–1653.
    Medical condition
    Influenza
    Product
    GSK1557484A, GSK1562902A
    Collaborators
    Not applicable
    Study date(s)
    July 2007 to October 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    Yes
    • Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
    • Good general health as assessed by medical history and physical examination.
    • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
    • 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
    Huntsville, Alabama, United States, 35802
    Status
    Study Complete
    Location
    GSK Investigational Site
    Halifax, Nova Scotia, Canada, B3K 6R8
    Status
    Study Complete
    Location
    GSK Investigational Site
    Truro, Nova Scotia, Canada, B2N 1L2
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 4J6
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lenexa, Kansas, United States, 66219
    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

    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
    2008-17-06
    Actual study completion date
    2008-24-10

    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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