Last updated: 11/04/2018 01:06:15

Immunogenicity and safety of DTPa-HBV-IPV/Hib compared to DTPa-IPV/Hib and HBV administered concomitantly

GSK study ID
217744/031
See study documents
Clinicaltrials.gov ID
NCT01457495
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: Study to assess immunogenicity and reactogenicity of SB Biologicals’ DTPa-HBV-IPV/Hib vaccine given as three-dose primary vaccination course compared to DTPa-IPV/Hib and HBV administered concomitantly at separate sites
Trial description: This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals’ (formerly SmithKline Beecham Biologicals’) DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with antibody titers equal to or greater than cut-off value.

Timeframe: One month after the 2nd dose of the primary vaccination course (month 3)

Secondary outcomes:

Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects

Timeframe: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)

Immunogenicity with respect to components of the study vaccines in terms of antibody titers

Timeframe: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)

Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response

Timeframe: One month after the 3rd dose of the primary vaccination course (Month 9)

Occurrence of solicited local symptoms

Timeframe: Within 4 days after each vaccination and overall

Occurrence of solicited general symptoms

Timeframe: Within 4 days after each vaccination and overall

Occurrence of unsolicited symptoms

Timeframe: Within 30 days after each vaccination, and overall

Occurrence of serious AEs

Timeframe: Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination

Interventions:
  • Biological/vaccine: DTPa-HBV-IPV/Hib (Infanrix-hexa™)
  • Biological/vaccine: DTPa-IPV/Hib (Infanrix-IPV/Hib™)
  • Biological/vaccine: HBV (Engerix™-B)
    • Enrollment:
    312
    Primary completion date:
    1999-30-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis B, Diphtheria, Haemophilus influenzae type b (Hib), Poliomyelitis, Pertussis, Tetanus
    Product
    Combined Diphteria, Tetanus, Acellular Petussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine
    Collaborators
    Not applicable
    Study date(s)
    September 1998 to September 1999
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 16 weeks
    Accepts healthy volunteers
    Yes
    • A male or female between 12 and 16 weeks of age at the time of the first vaccination.
    • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
    • Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
    Inclusion and exclusion criteria
    Inclusion criteria:

      A male or female between 12 and 16 weeks of age at the time of the first vaccination.

      • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
      • Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
    Exclusion criteria:

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

      • Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
      • Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
      • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
      • History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
      • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
      • Major congenital defects or serious chronic illness.
      • Progressive neurological disorders.
      • Administration of immunoglobulins and/or any blood products since birth and during the study period.
      • Acute febrile illness at the time of planned vaccination.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    1999-30-09
    Actual study completion date
    1999-30-09

    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

    Additional information
    Not applicable
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