Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/8/2018 |
| Start Date: | May 2010 |
| End Date: | December 30, 2014 |
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.
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.
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.
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 :
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