Last updated: 01/23/2020 12:10:15

Safety study of pandemic candidate influenza vaccines in the elderly population

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GSK study ID
102499
See study documents
Clinicaltrials.gov ID
NCT00306995
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: A phase III, open, randomized, multicenter, comparative vaccination study to evaluate the immunogenicity and reactogenicity of various formulations of a monovalent candidate pandemic influenza A vaccine in individuals over 60 years of age
Trial description: Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Serum haemagglutination-inhibition (HI) antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2)

Timeframe: At Day 10 post Dose 1

Serum HI antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2)

Timeframe: At Day 21 post Dose 1

Serum HI antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2)

Timeframe: At Day 21 post Dose 2 (Day 42)

Serum HI antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2)

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Number of seroconverted subjects against influenza A subtype H9N2

Timeframe: At Day 10 post Dose 1

Number of seroconverted subjects against influenza A subtype H9N2

Timeframe: At Day 21 post Dose 1

Number of seroconverted subjects against influenza A subtype H9N2

Timeframe: At Day 21 post Dose 2 (Day 42)

Number of seroconverted subjects against influenza A subtype H9N2

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Seroconversion factor for influenza A subtype H9N2

Timeframe: At Day 10 post Dose 1

Seroconversion factor for influenza A subtype H9N2

Timeframe: At Day 21 post Dose 1

Seroconversion factor for influenza A subtype H9N2

Timeframe: At Day 21 post Dose 2 (Day 42)

Seroconversion factor for influenza A subtype H9N2

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Number of seroprotected subjects against H9N2

Timeframe: At Day 10 post Dose 1

Number of seroprotected subjects against H9N2

Timeframe: At Day 21 post Dose 1

Number of seroprotected subjects against H9N2

Timeframe: At Day 21 post Dose 2 (Day 42)

Number of seroprotected subjects against H9N2

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Number of subjects with seroprotection power against H9N2

Timeframe: At Day 10 post Dose 1

Number of subjects with seroprotection power against H9N2

Timeframe: At Day 21 post Dose 1

Number of subjects with seroprotection power against H9N2

Timeframe: At Day 21 post Dose 2 (Day 42)

Number of subjects with seroprotection power against H9N2

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Serum HI antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2)

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Number of seroconverted subjects against influenza A subtype H9N2

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Seroconversion factor for influenza A subtype H9N2

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Number of seroprotected subjects against H9N2

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Number of subjects with seroprotection power against H9N2

Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Secondary outcomes:

Number of subjects with solicited local symptoms

Timeframe: During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses

Number of subjects with solicited local symptoms

Timeframe: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368)

Number of subjects with solicited general symptoms

Timeframe: During the 4-days (Day 0-3) post Dose 1

Number of subjects with solicited general symptoms

Timeframe: During the 4-days post Dose 2 (Days 21-24)

Number of subjects with solicited general symptoms

Timeframe: During the 4-Days (Day 0-3) across doses 1 and 2

Number of subjects with solicited general symptoms

Timeframe: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368)

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 30-days (Day 0-30) post vaccination

Number of subjects with unsolicited AEs

Timeframe: During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)

Number of subjects with serious adverse events (SAEs)

Timeframe: From Day 0 to Day 51

Number of subjects with SAEs

Timeframe: Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days -394 for Subset 2 groups)

Number of subjects with any SAEs

Timeframe: Up to 30-day post Dose 3 (Days 365-394)

Percentage of subjects with antibody persistence

Timeframe: At Days 189 and 365

Frequency of antigen-specific cluster of differentiation 4 (CD4) T-cells

Timeframe: At Days 0, 10, 21 and 42 post vaccination

Frequency of antigen-specific CD4 T-cells

Timeframe: At Days 0, 10, 21 and 42 post-vaccination

Cytokine-positive CD4 T-cells frequency

Timeframe: At Days 10, 21 and 42 post-vaccination

Frequency of antigen-specific cluster of differentiation 8 (CD8) T-cells

Timeframe: At Days 0, 10, 21 and 42 post-vaccination

Frequency of antigen-specific CD8 T-cells

Timeframe: At Days 0, 10, 21 and 42 post-vaccination

Cytokine-positive CD8 T-cells frequency

Timeframe: At Days 0, 10 and 21

Number of subjects with solicited local symptoms

Timeframe: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368)

Number of subjects with solicited general symptoms

Timeframe: During the 4-days post Dose 2 (Days 21-24)

Number of subjects with solicited general symptoms

Timeframe: During the 4-Days (Day 0-3) across doses 1 and 2

Number of subjects with solicited general symptoms

Timeframe: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368)

Interventions:
  • Biological/vaccine: SB218352_15
  • Biological/vaccine: SB218352_8
  • Biological/vaccine: SB218352_4
  • Biological/vaccine: SB218352_2
  • Biological/vaccine: SB218352_8AL
  • Biological/vaccine: SB218352_4AL
  • Biological/vaccine: SB218352_2AL
    • Enrollment:
    385
    Primary completion date:
    2006-04-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    SB218352
    Collaborators
    Not applicable
    Study date(s)
    May 2005 to July 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    60+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol
    • A male or female aged over 60 years at the time of vaccination.
    • Written informed consent obtained from the subject. Exclusion criteria:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
    • Participation in an earlier study with a candidate pandemic H9N2 vaccine.
    • Acute disease at the time of enrolment.
    • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • Drug and/or alcohol dependency.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bad Bramstedt, Schleswig-Holstein, Germany, 24576
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bad Segeberg, Schleswig-Holstein, Germany, 23795
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01219
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01307
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Elmshorn, Schleswig-Holstein, Germany, 25335
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Finsterwalde, Brandenburg, Germany, 03238
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 10 Results

    Study documents

    Clinical study report
    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
    2006-04-07
    Actual study completion date
    2006-04-07

    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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