Last updated: 11/04/2018 01:07:15

Immunogenicity and reactogenicity of DTPa-HBV-IPV/Hib, compared to DTPa-HBV-IPV and Hib administered separately

GSK study ID
217744/054
See study documents
Clinicaltrials.gov ID
NCT01457508
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 the immunogenicity and reactogenicity of DTPa-HBV-IPV vaccine mixed with Hib vaccine to healthy infants at 3, 5 and 11 months of age, compared to each vaccine administered separately
Trial description: This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ (formerly SB Biologicals’) DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value

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

Secondary outcomes:

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

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

Immunogenicity with respect to the 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 ( Month 8 and 9)

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

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

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

Timeframe: One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3)

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 adverse events

Timeframe: Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9)

Interventions:
  • Biological/vaccine: DTPa-HBV-IPV/Hib (Infanrix hexa™)
  • Biological/vaccine: DTPa-HBV-IPV (Infanrix penta™)
  • Biological/vaccine: Hib (Hiberix™)
    • Enrollment:
    440
    Primary completion date:
    2000-31-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Crovari P. et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001.
    Gabutti G. et al. (2004) Evaluation of the immunogenicity and reactogenicity of DTPa-HBV-IPV combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 36 (8): 585-592.
    Van Der Meeren O et al. (2012) Immunogenicity of Infanrix™ hexa administered at 3, 5 and 11 months of age. Vaccine. 30(17):2710-2714.
    Medical condition
    Hepatitis B, Diphtheria, Haemophilus influenzae type b (Hib), Poliomyelitis, Pertussis, Tetanus
    Product
    Combined Diphtheria, Tetanus, Acellular Pertussis Adsorbed, Hepatitis B (Recombinant), Inactivated Polio Vaccine
    Collaborators
    Not applicable
    Study date(s)
    January 1999 to March 2000
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 16 weeks
    Accepts healthy volunteers
    Yes
    • A male or female 3 months 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.
    • The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Inclusion and exclusion criteria
    Inclusion criteria:

      A male or female 3 months 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:

      The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:

      • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
      • Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
      • Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
      • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
      • History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
      • History of allergic disease or reactions 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.
      • History of seizures or of any neurological disease at study entry.
      • Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
      • Acute disease at time of enrolment

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2000-31-03
    Actual study completion date
    2000-31-03

    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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