Last updated: 11/03/2018 11:34:36

Immunogenicity and reactogenicity of a booster dose of GSK Bio's DTPa-HBV-IPV/Hib vaccine

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GSK study ID
111344
See study documents
Clinicaltrials.gov ID
NCT00627458
See results summary
EudraCT ID
2007-005343-16
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: Immunogenicity and reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine when given as a booster dose
Trial description: The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of seroprotected subjects against diphtheria (D) and tetanus (T) toxoids

Timeframe: Before the booster administration (At Month 0)

Number of seroprotected subjects against diphtheria (D) and tetanus (T) toxoids

Timeframe: One month after the booster vaccination (At Month 1)

Number of seroprotected subjects against Hepatitis B surface antigen (HBs)

Timeframe: Before the booster vaccination (At Month 0)

Number of seroprotected subjects against Hepatitis B surface antigen (HBs)

Timeframe: One month after the booster vaccination (At Month 1)

Number of seroprotected subjects against Poliovirus type 1, type 2 and type 3

Timeframe: Before the booster vaccination (At Month 0)

Number of seroprotected subjects against Poliovirus type 1, type 2 and type 3

Timeframe: One month after the booster vaccination (At Month 1)

Number of seroprotected subjects against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)

Timeframe: Before the booster vaccination (At Month 0)

Number of seroprotected subjects against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)

Timeframe: One month after the booster vaccination (At Month 1)

Number of seroprotected subjects against polyribosyl-ribitol-phosphate (PRP)

Timeframe: Before the booster vaccination (At Month 0)

Number of seroprotected subjects against polyribosyl-ribitol-phosphate (PRP)

Timeframe: One month after the booster vaccination (At Month 1)

Number of subjects with a vaccine response to PT, FHA and PR

Timeframe: One month after the booster vaccination (At Month 1)

Anti-D and anti-T antibody concentrations

Timeframe: Before the booster vaccination (At Month 0)

Anti-D and anti-T antibody concentrations

Timeframe: One month after the booster vaccination (At Month 1)

Anti-PT, anti-FHA and anti-PRN antibody concentrations

Timeframe: Before the booster vaccination (At Month 0)

Anti-PT, anti-FHA and anti-PRN antibody concentrations

Timeframe: One month after the booster vaccination (At Month 1)

Anti-HBs antibody concentrations

Timeframe: Before the booster vaccination (At Month 0)

Anti-HBs antibody concentrations

Timeframe: One month after the booster vaccination (At Month 1)

Anti-poliovirus type 1, type 2 and type 3 antibody titers

Timeframe: Before the booster vaccination (At Month 0)

Anti-poliovirus type 1, type 2 and type 3 antibody titers

Timeframe: One month after the booster vaccination (At Month 1)

Anti-PRP antibody concentrations

Timeframe: Before the booster vaccination (At Month 0)

Anti-PRP antibody concentrations

Timeframe: One month after the booster vaccination (At Month 1)

Secondary outcomes:

Number of seroprotected subjects against diphtheria (D) and tetanus (T) toxoids

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of seroprotected subjects against Hepatitis B surface antigen (HBs)

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of seroprotected subjects against Poliovirus type 1, type 2 and type 3

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of seroprotected subjects against PT, FHA and PRN

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of seroprotected subjects against polyribosyl-ribitol-phosphate (PRP)

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-D and anti-T antibody concentrations

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-PT, anti-FHA, anti-PRN antibody concentrations

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-HBs antibody concentrations

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-poliovirus type 1, 2 and 3 antibody titers

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Anti-PRP antibody concentrations

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Number of subjects with a vaccine response to PT, FHA and PR

Timeframe: One month after the booster dose (At Month 1)

Number of subjects with any solicited local symptoms

Timeframe: During the 4-day (Days 0–3) follow-up period after the booster vaccination

Number of subjects with any solicited general symptoms

Timeframe: During the 4-day (Days 0–3) follow-up period after the booster vaccination

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 31-day (Day 0–30) follow-up period after the booster vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: From Month 0 to Month 1, during the entire study period

Number of subjects reporting concomitant medications

Timeframe: During the 4-day (Days 0-3) follow-up period after the booster vaccination

Interventions:
  • Biological/vaccine: Infanrix Hexa
    • Enrollment:
    403
    Primary completion date:
    2008-18-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    acellular pertussis, Diphtheria, Poliomyelitis, Haemophilus influenzae type b, Tetanus, Hepatitis B
    Product
    SB217744
    Collaborators
    Not applicable
    Study date(s)
    February 2008 to August 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    16 - 20 months
    Accepts healthy volunteers
    Yes
    • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
    • Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster 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 booster vaccine dose.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

      • Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
      • A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
      • Written informed consent obtained from the parent or guardian of the subject
      • Healthy subjects as established by medical history and clinical examination before entering into the study.
    Exclusion criteria:

      Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster 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 booster vaccine dose.
      • Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
      • Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
      • Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
      • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
      • Acute disease at the time of enrolment.
      • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Jarvenpaa, Finland, 04400
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Turku, Finland, 20520
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oulu, Finland, 90220
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vantaa, Finland, 01300
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pori, Finland, 28100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tampere, Finland, 33100
    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
    2008-18-08
    Actual study completion date
    2008-18-08

    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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