Clinical trial NCT01129362: Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines
Official title: Surveillance for Rates of Pertussis Disease Among Persons Birth Through 59 Months of Age Receiving Pentacel® or Other Pertussis Vaccines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis
Keywords: Pertussis
Whooping Cough
Pertussis Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 1195
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wisconsin residents younger than 60 months of age.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 :

* Not applicable

Primary outcomes:
measure: Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH)
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Conway JH, Davis JP, Eickhoff JC, Pool V, Greenberg DP, Decker MD. Brand-specific rates of pertussis disease among Wisconsin children given 1-4 doses of pertussis Vaccine, 2010-2014. Vaccine. 2020 Oct 21;38(45):7063-7069. doi: 10.1016/j.vaccine.2020.09.016. Epub 2020 Sep 11.
citation: 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. No abstract available.