Last updated: 11/04/2018 01:07:27

Immunogenicity and reactogenicity of DTPa-HBV-IPV/Hib vaccine followed by the same vaccine and oral polio vaccine

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GSK study ID
217744/060
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Clinicaltrials.gov ID
NCT01457560
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 mixed with Hib vaccine in healthy infants, followed by a dose of the same vaccine administered simultaneously with one dose of oral polio vaccine (OPV)
Trial description: This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals’ (formerly SmithKline Beecham Biologicals’) combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
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 values

Timeframe: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)

Secondary 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 values

Timeframe: Before the first dose ( Month 0 )

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

Timeframe: Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).

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

Timeframe: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).

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

Timeframe: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).

Number of subjects with solicited and unsolicited adverse events

Timeframe: After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall

Number of subjects with serious adverse events

Timeframe: During the study period (Month 0 to Month 9)

Interventions:
  • Biological/vaccine: DTPa-HBV-IPV/Hib (Infanrix hexa™)
  • Biological/vaccine: OPV
    • Enrollment:
    80
    Primary completion date:
    2001-30-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    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, acellular pertussis, Haemophilus influenzae type b, Diphtheria, Tetanus, Poliomyelitis
    Product
    Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine
    Collaborators
    Not applicable
    Study date(s)
    February 2000 to April 2001
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 16 weeks
    Accepts healthy volunteers
    Yes
    • The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.
    • Healthy male and female subjects in the ≥12 and <16 weeks of life at the time of the first vaccination.
    • The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.
    • 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:

      The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.

      • Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant 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 exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.

      • 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.
      • 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 the time of enrolment.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
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    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
    2001-30-04
    Actual study completion date
    2001-30-04

    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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