Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01129362
First received: May 20, 2010
Last updated: February 11, 2016
Last verified: February 2016

May 20, 2010
February 11, 2016
May 2010
February 2015   (final data collection date for primary outcome measure)
Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01129362 on ClinicalTrials.gov Archive Site
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Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines
Surveillance for Rates of Pertussis Disease Among Persons Birth Through 59 Months of Age Receiving Pentacel® or Other Pertussis Vaccines

The purpose of this cohort study is to determine vaccine-specific rates of pertussis disease during the period of the study, among Wisconsin residents younger than 60 months of age (the Surveillance Population), and to descriptively compare the proportion of such persons vaccinated with Pentacel® vaccine who acquire pertussis disease to the proportion of such persons vaccinated with any other Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccine who acquire pertussis disease.

Primary Objective:

To determine the rates and relative risk of pertussis disease among Surveillance Population members who have received Pentacel vaccine or another pertussis vaccine.

The study will be conducted by the University of Wisconsin School of Medicine and Public Health, in collaboration with the Wisconsin Division of Public Health (WDPH).

Epidemiological and laboratory surveillance for pertussis disease among Wisconsin residents is routinely conducted by the WDPH. During the period of the study, de-identified data regarding all incident pertussis cases will be obtained from WDPH and vaccination coverage rates, by vaccine regimen, age group, and period of time, will be obtained from ongoing marketplace surveillance conducted on behalf of the Sponsor by a national sample-survey organization. Using these data, rates of pertussis disease will be determined.

No vaccine will be administered as part of this study.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
Wisconsin residents younger than 60 months of age.
Pertussis
  • Biological: Pentacel® (DTaP-IPV/Hib)
    0.5 mL dose, Intramuscular
    Other Name: Pentacel®
  • Biological: Other Pertussis Vaccines
    0.5 mL, Intramuscular
    Other Names:
    • DAPTACEL®
    • Tripedia®
    • TriHIBit®
    • Infanrix®
    • Pediarix®
  • Group 1
    Participants that only received Pentacel® vaccine.
    Intervention: Biological: Pentacel® (DTaP-IPV/Hib)
  • Group 2
    Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine.
    Intervention: Biological: Other Pertussis Vaccines
  • Group 3
    Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand.
    Intervention: Biological: Other Pertussis Vaccines
Decker MD, Hosbach P, Johnson DR, Pool V, Greenberg DP. Estimating the effectiveness of tetanus-diphtheria-acellular pertussis vaccine. J Infect Dis. 2015 Feb 1;211(3):497-8. doi: 10.1093/infdis/jiu477. Epub 2014 Aug 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
19172
June 2016
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria :

  • Persons will be under surveillance for this study whenever the following three conditions are true: the individual resides in Wisconsin, is age birth through 59 months, and is within the surveillance period of 01 October 2009 through 30 September 2014 (or as extended in order to accrue 61,761 person years of Pentacel vaccine exposure).

Exclusion Criteria :

Both
up to 59 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01129362
M5A16, UTN: U1111-1111-5171
No
Not Provided
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Sanofi Pasteur, a Sanofi Company
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP