Last updated: 11/07/2018 06:21:51

Safety and immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (H1N1) (GSK2340272A)

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GSK study ID
113528
See study documents
Clinicaltrials.gov ID
NCT00964158
See results summary
EudraCT ID
2009-013785-52
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 study of GSK Biologicals’ pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 17 years
Trial description: This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals’ investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects with haemagglutination-inhibition (HI) antibody concentrations above the cut-off value

Timeframe: At Day 0

Number of subjects with HI antibody concentrations above the cut-off value

Timeframe: At Day 42

Titers for serum HI antibodies

Timeframe: At Day 0

Titers for serum HI antibodies

Timeframe: At Day 42

Number of seroconverted (SCR) subjects in terms of HI antibodies

Timeframe: At Day 42

Number of seroprotected (SPR) subjects in terms of HI antibodies

Timeframe: At Day 42

Seroconversion factor (SCF) for HI antibody titers

Timeframe: At Day 42

Secondary outcomes:

Number of subjects with HI antibody concentrations above the cut-off value

Timeframe: At Days 0, 21, 42 and at Month 12

Titers for serum HI antibodies

Timeframe: At Days 0, 21, 42 and at Month 12

Number of seroconverted (SCR) subjects in terms of HI antibodies

Timeframe: At Days 21, 42 and at Month 12

Number of seroprotected subjects in terms of HI antibodies

Timeframe: At Days 0, 21, 42 and at Month 12

Seroconversion factor (SCF) for HI antibody titers

Timeframe: At Days 21, 42 and at Month 12

Number of subjects with neutralizing antibody concentrations above the cut-off value

Timeframe: At Days 0, 21 and 42

Titers for serum neutralizing antibodies

Timeframe: At Days 0, 21 and 42

Number of subjects with neutralizing antibody concentrations above the cut-off value

Timeframe: At Month 12

Titers for serum neutralizing antibodies

Timeframe: At Month 12

Number of seroconverted (SCR) subjects in terms of H1N1 neutralizing antibodies

Timeframe: At Days 21 and 42

Number of seroconverted (SCR) subjects in terms of H1N1 neutralizing antibodies

Timeframe: At Month 12

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 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 medically-attended events (MAEs)

Timeframe: During the entire study period (from Day 0 up to Month 12)

Number of subjects with any adverse events of specific interest (AESIs), including potential immune-mediated disease (pIMDs)

Timeframe: During the entire study period (from Day 0 up to Month 12)

Number of subjects with normal or abnormal biochemical levels

Timeframe: At Days 0, 21 and 42

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

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

Timeframe: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (from Day 0 up to Month 12)

Interventions:
  • Biological/vaccine: Pandemic influenza vaccine GSK2340272A
    • Enrollment:
    210
    Primary completion date:
    2010-27-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Garcia-Sicilia J et al. (2011) Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 29(26):4353-4361.
    Garcia-Sicilia J et al. (2015) Safety and persistence of the humoral and cellular immune responses induced by two doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: two open, uncontrolled studies. Hum Vaccin Immunother. 11(10):2359-2369.
    Medical condition
    Influenza
    Product
    GSK2340272A
    Collaborators
    Not applicable
    Study date(s)
    September 2009 to November 2010
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    3 - 17 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
    • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
    • 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.
    • Clinically or virologically confirmed influenza infection within six months preceding the study start.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.

      • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
      • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
      • Healthy children as established by medical history and clinical examination when entering into the study.
      • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.
    Exclusion criteria:

      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.

      • Clinically or virologically confirmed influenza infection within six months preceding the study start.
      • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
      • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
      • Acute disease and/or fever at the time of enrolment
      • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
      • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
      • Previous administration of any H1N1 A/California-like vaccine.
      • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
      • If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
      • Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
      • Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
      • Child in Care.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Sevilla, Spain, 41013
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Madrid, Spain, 28046
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Móstoles/Madrid, Spain, 28935
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Burgos, Spain, 09005
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bilbao, Spain, 48013
    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)
    Protocol
    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
    2010-27-11
    Actual study completion date
    2010-27-11

    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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