Last updated: 07/17/2024 17:36:46

Post Market Surveillance for Infanrix™

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GSK study ID
208355/128
See study documents
Clinicaltrials.gov ID
NCT00908115
See results summary
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: Evaluation of safety and efficacy through Post Market Surveillance for Infanrix™, the DTaP mixed vaccine
Trial description: The purpose of this study was to investigate the following questions through post-marketing surveillance:
• Unknown/Unexpected adverse events and the serious adverse events.
• The circumstances in which the adverse events occurred under the practical application.
• Factors considered to have influence on safety.
• Factors considered to have influence on efficacy.
• Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Subjects reporting Serious Adverse Events

Timeframe: Since the beginning of the study and during the entire study period (up to 6 years)

Number of subjects reporting solicited symptoms

Timeframe: During the 4-week follow-up period after each dose

Number of Subjects Reporting Unsolicited Adverse Events

Timeframe: Within the 31-day (Day 0-30) following vaccination.

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: GSK Biologicals' Infanrix™
    • Enrollment:
    1258
    Primary completion date:
    2008-23-06
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Diphtheria, acellular pertussis, Tetanus
    Product
    SB208355
    Collaborators
    Not applicable
    Study date(s)
    August 2003 to June 2008
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • All children receiving Infanrix™ were eligible for this survey.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • All children receiving Infanrix™ were eligible for this survey.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Daegu, South Korea, 700-712
    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
    2008-23-06
    Actual study completion date
    2008-23-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

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    Additional information
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