Last updated: 11/04/2018 01:14:15

Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, followed by DTPa-IPV/Hib vaccine in infants who received hepatitis B vaccine

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GSK study ID
217744/100
See study documents
Clinicaltrials.gov ID
NCT00325143
See results summary
EudraCT ID
2012-002439-26
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: Assess safety & reactogenicity of DTPa-IPV/Hib vaccine admnd at 3 & 4 mths & DTPa-HBV-IPV/Hib vaccine admnd at 5 mths, followed by DTPa-IPV/Hib vaccine at 18 mths in infants who received hepatitisB vaccine at birth & at one month of age
Trial description: To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects reporting any solicited local symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Number of subjects reporting any solicited general symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Secondary outcomes:

Number of subjects reporting any unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Number of subjects reporting any large swelling reactions

Timeframe: At Month 15, post-booster dose

Number of subjects reporting any serious adverse events (SAEs)

Timeframe: During the entire study period (from Month 0 up to Month 21)

Interventions:
  • Biological/vaccine: DTPa-HBV-IPV/Hib
  • Biological/vaccine: DTPa-IPV/Hib vaccine
    • Enrollment:
    702
    Primary completion date:
    2007-01-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lim FS et al. (2011) Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 42(1):138-47.
    Medical condition
    Haemophilus influenzae type b, Diphtheria, Tetanus, Poliomyelitis, acellular pertussis
    Product
    SB217744
    Collaborators
    Not applicable
    Study date(s)
    December 2003 to February 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    11 - 17 weeks
    Accepts healthy volunteers
    Yes
    • Inclusion criteria
    • Subjects must have been enrolled in the Rota-028 study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria
    • Subjects must have been enrolled in the Rota-028 study.
    • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
    • A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
    • Written informed consent obtained from the parent or guardian of the subject.
    • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    • Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age. Exclusion criteria
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs 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 the vaccine and ending 30 days after.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
    • A family history of congenital or hereditary immunodeficiency.
    • 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 any neurologic disorders or seizures.
    • Acute disease at the time of enrolment.
    • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 119074
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 229899
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 228510
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-01-02
    Actual study completion date
    2007-01-02

    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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