Last updated: 11/03/2018 00:26:43

Immunogenicity & safety of GSK’s combined DTPa-HBV-IPV/Hib vaccine in Indian infants at 2 diff vaccination schedules

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GSK study ID
104005
See study documents
Clinicaltrials.gov ID
NCT00316147
EudraCT ID
2012-002426-70
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 IIIb, open, randomized, multicenter study to assess the immunogenicity & safety of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in Indian infants when given at 6-10-14 weeks of age or at 2-4-6 months of age
Trial description: In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:
- one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months 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: DTPa-HBV-IPV/Hib vaccine
    • Enrollment:
    224
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diphtheria, acellular pertussis, Tetanus, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis
    Product
    SB217744
    Collaborators
    Not applicable
    Study date(s)
    December 2005 to August 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 10 weeks
    Accepts healthy volunteers
    Yes
    • A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
    • Written informed consent obtained from the parent or guardian of the subject.
    • Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose.
    Inclusion and exclusion criteria
    Inclusion criteria:

      A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.

      • Written informed consent obtained from the parent or guardian of the subject.
      • Born after a normal gestation period (between 36 and 42 weeks).
      • Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.
    Exclusion criteria:

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

      • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs 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 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
      • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
      • Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Goa, India, 403202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Delhi, India, 110002
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baroda, India, 390 001
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bangalore, India, 560034
    Status
    Study Complete
    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
    2006-14-08

    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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