Last updated: 11/03/2018 08:47:14

Study to assess the safety & reactogenicity of GSK Biologicals’ DTPa/Hib vaccine when given at 3, 4 and 5 months of age

Request patient level data
GSK study ID
106345
See study documents
Clinicaltrials.gov ID
NCT00379977
EudraCT ID
Not applicable
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: Open, primary vaccination study to assess safety and reactogenicity of GSK Biologicals’ DTPa/Hib vaccine when administered to healthy chinese infants at 3, 4 and 5 months of age.
Trial description: This study will evaluate the safety and reactogenicity of GSK Biologicals’ Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: diphtheria, tetanus, pertussis & Hib vaccine
    • Enrollment:
    30
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Tetanus, Haemophilus influenzae type b, acellular pertussis, Diphtheria
    Product
    SB208355
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to December 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    90 - 120 days
    Accepts healthy volunteers
    Yes
    • A male or female between, and including, 90 and 120 days of age at the time of the first vaccination
    • Written informed consent obtained from the parent or guardian of the subject
    • subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
    • subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b (Hib) diseases can not participate.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A male or female between, and including, 90 and 120 days of age at the time of the first vaccination Written informed consent obtained from the parent or guardian of the subject
    Exclusion criteria:
    • subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate, subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b (Hib) diseases can not participate.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Nanning, Guangxi, China, 530021
    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
    2006-25-12

    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