Last updated: 11/03/2018 08:36:08

Compare immunogenicity & safety of 2 formulations of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine given in healthy infants

Request patient level data
GSK study ID
105910
See study documents
Clinicaltrials.gov ID
NCT00320463
EudraCT ID
2012-002427-15
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: Compare immunogenicity & reactogenicity of 2 formulations of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (new vs current) given in healthy infants. The DTPa-HBV-IPV vaccine (new formulation) will also be assessed in a 3rd group of subjects
Trial description: In this study, infants will be randomly allocated into three groups:
- one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
- the third group of subjects will receive DTPa-HBV-IPV vaccine
The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: DTPa-HBV-IPV/Hib vaccine
    • Enrollment:
    415
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, acellular pertussis
    Product
    SB217744
    Collaborators
    Not applicable
    Study date(s)
    April 2006 to January 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    11 - 17 weeks
    Accepts healthy volunteers
    Yes
    • A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
    • Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
    • Use of any investigational or non-registered product (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.
    • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
    Inclusion and exclusion criteria
    Inclusion criteria:

      A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.

      • Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
      • Born after a normal gestation period (between 36 and 42 weeks).
      • Written informed consent obtained from the parent or guardian of the subject.
    Exclusion criteria:

      Use of any investigational or non-registered product (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.

      • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
      • Any chronic drug therapy to be continued during the study period.
      • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
      • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
      • Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
      • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. "

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Syktyvkar, Russia, 167011
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Perm, Russia, 614022
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Murmansk, Russia, 183046
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Syktyvkar, Russia, 167002
    Status
    Terminated/Withdrawn
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-25-01

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website