Last updated: 11/03/2018 20:38:31

Study to analyze the risk factors associated with pertussis/whooping cough infection among infants

GSK study ID
200158
See study documents
Clinicaltrials.gov ID
NCT01890850
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: Risk factors associated with pertussis among infants less than one-year of age
Trial description: This study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a United States (U.S.) commercially insured population. The study will utilize a large research data base associated with a geographically diverse U.S. health plan not limited by one geographic area or disease outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection will also be reported.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Assessment of claim identified pertussis/whooping cough

Timeframe: Up to one year

Assessment of health care resource utilization

Timeframe: Up to one year

Assessment of health care costs

Timeframe: Up to one year

Secondary outcomes:
Not applicable
Interventions:
  • Other: Retrospective database study using administrative claims data
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Diphtheria, acellular pertussis, Tetanus
    Product
    SB217744
    Collaborators
    Optum, Carolyn Martin and Ami Buikema
    Study date(s)
    July 2013 to November 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 1 years
    Accepts healthy volunteers
    No
    • Date of birth between July 1, 2005 and September 30, 2010.
    • Enrollment in a commercial health plan within one month of birth.
    • Enrollment does not include medical and pharmacy coverage.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Date of birth between July 1, 2005 and September 30, 2010.

      • Enrollment in a commercial health plan within one month of birth.
      • Known sex and geographic region.
      • Infants will be included as a pertussis/whooping cough case if they meet the diagnosis criteria Infants not identified as a pertussis/whooping cough case are eligible for inclusion as a control.
    Exclusion criteria:

      Enrollment does not include medical and pharmacy coverage.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2013-30-11

    Plain language summaries

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

    Additional information about the trial

    Not applicable
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