Last updated: 11/07/2018 02:46:59

Evaluate reactogenicity & immunogenicity of an influenza pandemic candidate vaccine (GSK1562902A) in primed adults

GSK study ID
109817
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: Evaluate the reactogenicity & immunogenicity of 1 or 2 booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in primed adults aged between 19 & 61 years
Trial description: The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Titers for serum H5N1 haemagglutinin inhibition (HI) antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Day 0

Titers for serum H5N1 haemagglutinin inhibition (HI) antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Day 21

Number of seroconverted subjects for H5N1 HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Day 21

Seroconversion factor (SCF) for H5N1 HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Day 21

Number of seroprotected subjects for H5N1 HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Day 0

Number of seroprotected subjects for H5N1 HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Day 21

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

Timeframe: During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination

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

Timeframe: During the 30-day (Days 0-29) follow-up period after the first vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (From Day 0 up to Month 24)

Secondary outcomes:

Titers for serum neutralizing HI antibodies against A/Indonesia/05/2005 strain

Timeframe: At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)

Titers for serum neutralizing HI antibodies against A/Indonesia/05/2005 stain

Timeframe: At Months 6, 12, 18 and 24

Titers for serum H5N1 haemaglutinin-inhibition (HI) antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Days 0, 7, 14, 21, 28, 35 and 42

Titers for serum H5N1 HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Months 6, 12, 18 and 24

Number of seroconverted (SCR) subjects for HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Days 7,14, 21, 35 and 42

Number of seroconverted (SCR) subjects for HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Months 6, 12, 18 and 24

Number of seroconverted (SCR) subjects for neutralizing HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Days 21 (post-vaccination one) and 42 (post-vaccination two)

Number of seroconverted (SCR) subjects for neutralizing HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Months 6, 12, 18 and 24

Seroconversion factor (SCF) for H5N1 haemagglutinin-inhibition (HI) antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Days 7, 14, 21, 35 and 42

Seroconversion factor (SCF) for H5N1 haemagglutinin-inhibition (HI) antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Months 6, 12, 18 and 24

Number of seroprotected (SPR) subjects for HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Days 0, 7, 14, 21, 28, 35 and 42

Number of seroprotected (SPR) subjects for HI antibodies against the A/Indonesia/05/2005 strain

Timeframe: At Months 6, 12, 18 and 24

Frequency of antigen-specific CD4/CD8 T-cells (per 10E6) in tests identified as producing at least two out of four different cytokines

Timeframe: At Days 0 and 21

Frequency of antigen-specific CD4/CD8 T-cells (per 10E6) in tests identified as producing at least two out of four different cytokines

Timeframe: At Months 6, 12, 18 and 24

Interventions:
  • Biological/vaccine: Pandemic influenza candidate vaccine (GSK1562902A) – 1 dose
  • Biological/vaccine: Pandemic influenza candidate vaccine (GSK1562902A) – 2 doses
  • Enrollment:
    350
    Primary completion date:
    2009-12-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Leroux-Roels I et al. (2010) Priming with AS03A-adjuvanted H5N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: An open non-randomised extension of a double-blind randomised primary study. Vaccine. 28(3): 849-857.
    Medical condition
    Influenza
    Product
    GSK1562902A, GSK2321142A
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to October 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    19 - 61 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
    • For previously primed subjects: participation in the primary study (NCT00309634).
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • For unprimed subjects who did not participate in the primary study (NCT00309634): Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    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
    2009-12-10
    Actual study completion date
    2009-12-10

    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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