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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-08

Study Completion Date

2014-12-30

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.

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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.

Conditions

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Pertussis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Participants that only received Pentacel® vaccine.

Pentacel® (DTaP-IPV/Hib)

Intervention Type BIOLOGICAL

0.5 mL dose, Intramuscular

Group 2

Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine.

Other Pertussis Vaccines

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Group 3

Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand.

Other Pertussis Vaccines

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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Pentacel® (DTaP-IPV/Hib)

0.5 mL dose, Intramuscular

Intervention Type BIOLOGICAL

Other Pertussis Vaccines

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Pentacel® DAPTACEL® Tripedia® TriHIBit® Infanrix® Pediarix®

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).