Last updated: 11/03/2018 20:38:31
Study to analyze the risk factors associated with pertussis/whooping cough infection among infants
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Control
Primary completion date:
Not applicable
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:
- 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.
Date of birth between July 1, 2005 and September 30, 2010.
Exclusion criteria:
Enrollment does not include medical and pharmacy coverage.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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