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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surveillance for Rates of Pertussis Disease Among Persons Birth Through 59 Months of Age Receiving Pentacel® or Other Pertussis Vaccines

Conditions
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Pertussis

Intervention / Treatment
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* Biological: Pentacel® (DTaP-IPV/Hib)
* Biological: Other Pertussis Vaccines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Participants that only received Pentacel® vaccine. | Biological: Pentacel® (DTaP-IPV/Hib)<br>* 0.5 mL dose, Intramuscular<br>* Other names: Pentacel®;|
| Group 2<br>Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine. | Biological: Other Pertussis Vaccines<br>* 0.5 mL, Intramuscular<br>* Other names: Pediarix®;|
| Group 3<br>Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand. | Biological: Other Pertussis Vaccines<br>* 0.5 mL, Intramuscular<br>* Other names: Pediarix®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH) |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertussis, Whooping Cough, Pertussis Vaccine