Last updated: 07/17/2024 15:07:20

Assess the safety & reactogenicity of DTPa-IPV/Hib vaccine administered at 3, 4, 5 & 18 mths of age, in healthy infants

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GSK study ID
100917
See study documents
Clinicaltrials.gov ID
NCT00325156
See results summary
EudraCT ID
2015-001512-35
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: An open, multicentric, post-marketing surveillance study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib vaccine administered at 3, 4, 5 and 18 months of age, in healthy infants.
Trial description: To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The 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 and general symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period, across doses

Secondary outcomes:

Number of subjects reporting any unsolicited adverse events (AEs)

Timeframe: During the 30-day (Days 0-29) post-vaccination period

Number of subjects reporting large injection site swelling

Timeframe: At Month 18, post-booster dose

Number of subjects reporting any serious adverse events (SAEs)

Timeframe: During the entire study period

Interventions:
  • Biological/vaccine: GSK Biologicals’ combined DTPa-IPV/Hib vaccine
    • Enrollment:
    2590
    Primary completion date:
    2007-23-08
    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):138-147.
    Medical condition
    Diphtheria, Tetanus, Poliomyelitis, acellular pertussis, Haemophilus influenzae type b, Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
    Product
    SB213503
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to August 2007
    Type
    Interventional
    Phase
    4

    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.
    • 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 for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol 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, 308433
    Status
    Study Complete
    Contact us

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-23-08
    Actual study completion date
    2007-23-08

    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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