Last updated: 11/07/2018 13:18:16

To evaluate immunogenicity & safety of GSK Bio’s DTPa-HBV-IPV/Hib (mixed vaccine) and DTPa-IPV/Hib + HBV vaccines

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GSK study ID
217744/075
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Clinicaltrials.gov ID
NCT00366366
EudraCT ID
2011-004066-15
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: Phase III, open, randomised immunogenicity and reactogenicity study to assess the interchangeability between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd dose of primary vac. course in children who received HBV vac. at birth and one month of age and DTPa-IPV/Hib vac at 3-4 Mth of age
Trial description: This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Infanrix-Hexa
    • Enrollment:
    150
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lim et al. (2007) Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B- inactivated poliomyelitis-Haemophilus influenzae type b vaccine Ann Acad Med Singapore; 36 (10):801-806.
    Medical condition
    Hepatitis B
    Product
    Hepatitis B Vaccine, Recombinant
    Collaborators
    Not applicable
    Study date(s)
    September 2001 to September 2002
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    11 - 17 weeks
    Accepts healthy volunteers
    Yes
    • A male or female infant at the age of 11 - 17 weeks.
    • Written informed consent obtained from the parents or guardians of the subject.
    • Previous vaccination against measles, mumps, rubella and/or varicella.
    • Use of any investigational or non-registered drug or vaccine other than the study vaccines 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 infant at the age of 11
    • 17 weeks.
    • Written informed consent obtained from the parents or guardians of the subject.
    • Free of obvious health problems as established by clinical examination before entering into the study.
    • Hepatitis B vaccine at birth and one month of age.
    Exclusion criteria:
    • Previous vaccination against measles, mumps, rubella and/or varicella.
    • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • A family history of congenital or hereditary immunodeficiency.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
    • Major congenital defects.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

    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
    Not applicable
    Actual study completion date
    2002-30-09

    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

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    Additional information
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