Last updated: 04/25/2019 07:18:53

Study to evaluate the immunogenicity and safety of an investigational pandemic influenza vaccine in children

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GSK study ID
109825
See study documents
Clinicaltrials.gov ID
NCT01323946
See results summary
EudraCT ID
2011-004734-33
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: Safety and immunogenicity of GSK Biologicals’ (pre-) pandemic influenza candidate vaccine (GSK1562902A) in children aged 6 to 35 months
Trial description: The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals’ investigational vaccine GSK1562902A.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of seroconverted subjects in terms of H5N1 Hemagglutination Inhibition (HI) antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: At Day 192

Mean Geometric Change in terms of H5N1 HI antibodies against A/turkey/Turkey/01/2005 H5N1 virus strain

Timeframe: At Day 192

Number of seroprotected subjects in terms of H5N1 HI antibodies against A/turkey/Turkey/01/2005 H5N1 virus strain

Timeframe: At Day 192

Secondary outcomes:

Hemagglutination Inhibition (HI) antibody titers against the A/Indonesia/05/2005 H5N1 virus strain

Timeframe: At Day 0, Day 42, Day 182, Day 192 and Day 364

Hemagglutination Inhibition (HI) antibody titers against the A/turkey/Turkey/01/2005 H5N1 virus strain

Timeframe: At Day 0, Day 182, Day 192 and Day 364

Number of seropositive subjects in terms of H5N1 HI antibodies against A/Indonesia/05/2005

Timeframe: At Day 0, Day 42, Day 182, Day 192 and Day 364

Number of seropositive subjects in terms of H5N1 HI antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: At Day 0, Day 182, Day 192 and Day 364

Number of seroconverted subjects in terms of H5N1 HI antibodies against A/Indonesia/05/2005 H5N1 virus strain

Timeframe: At Day 42, Day 182, Day 192 and Day 364

Number of seroconverted subjects in terms of H5N1 HI antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: At Day 182 and Day 364

Number of seroprotected subjects in terms of H5N1 HI antibodies against A/Indonesia/05/2005 virus strain

Timeframe: At Day 0, Day 42, Day 182, Day 192 and Day 364

Number of seroprotected subjects in terms of H5N1 HI antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: Day 0, Day 182 and Day 364

Mean Geometric Change in terms of H5N1 HI antibodies against A/Indonesia/05/2005 H5N1 virus strain

Timeframe: At Day 42, Day 182, Day 192 and Day 364

Mean Geometric Change in terms of H5N1 HI antibodies against A/turkey/Turkey/01/2005 H5N1 virus strain

Timeframe: Day 182 and Day 364

Number of booster seroconverted subjects in terms of H5N1 HI antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: At Day 192 and Day 364

Booster factor in terms of neutralizing antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: At Day 192 and Day 364

Number of seropositive subjects in terms of serum neutralizing antibodies against A/Indonesia/05/2005 H5N1 virus strain

Timeframe: Day 0, Day 42, Day 182, Day 192 and Day 364

Number of seropositive subjects in terms of serum neutralizing antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: Day 0, Day 182, Day 192 and Day 364

Serum neutralizing antibody titers in terms of neutralizing antibodies against A/Indonesia/05/2005 H5N1 virus strain

Timeframe: Day 0, Day 42, Day 182, Day 192 and Day 364

Serum neutralizing antibody titers in terms of neutralizing antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: Day 0, Day 182, Day 192 and Day 364

Number of subjects with a vaccine response in terms of serum neutralizing antibodies against A/Indonesia/05/2005 H5N1 virus strain

Timeframe: At Day 42, Day 182, Day 192 and Day 364

Number of subjects with a vaccine response in terms of serum neutralizing antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: At Day 182, Day 192 and Day 364

Number of subjects with a booster vaccine response in terms of serum neutralizing antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain

Timeframe: At Day 192 and Day 364

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)

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

Timeframe: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)

Number of subjects with medically-attended events (MAEs)

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

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

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

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)

Number of subjects with serious adverse events (SAEs)

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

Interventions:
  • Biological/vaccine: GSK Biologicals’ investigational vaccine GSK1562902A
    • Enrollment:
    113
    Primary completion date:
    2012-22-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Nolan T et al. (2014) Heterologous prime-boost vaccination using an AS03B-adjuvanted influenza A(H5N1) vaccine in infants and children <3 years of age. J Infect Dis. 210(11):1800-1810.
    Medical condition
    Influenza
    Product
    GSK1562902A
    Collaborators
    Not applicable
    Study date(s)
    April 2011 to November 2012
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 35 months
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
    • Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
    • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.

      • Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
      • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
      • Healthy children as established by medical history and clinical examination before entering the study.
      • Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
      • Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.
    Exclusion criteria:

      Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

      • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
      • Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
      • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
      • History of any neurological disorders or seizures.
      • Acute disease at the time of enrolment.
      • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
      • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
      • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
      • Child in care.
      • Previous vaccination at any time with an H5N1 vaccine.
      • Medical history of physician-confirmed infection with a H5N1 virus.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Carlton, Victoria, Australia, 3053
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Garran, Australian Capital Territory, Australia, 2606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Adelaide, South Australia, Australia, 5006
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Singapore, Singapore, 119074
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 228510
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Westmead, New South Wales, Australia, 2145
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2012-22-06
    Actual study completion date
    2012-02-11

    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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