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

Completed

• Conditions: Pertussis
• Interventions: Biological: Pentacel® (DTaP-IPV/Hib); Biological: Other Pertussis Vaccines

• Registration Number: NCT01129362
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study Start: 2010-02-08
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Primary Completion: 2014-12-30
• Study Completion: 2014-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Pentacel® (DTaP-IPV/Hib)	Participants that only received Pentacel® vaccine.
Group 2	Other Pertussis Vaccines	Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine.
Group 3	Other Pertussis Vaccines	Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand.

Primary Outcome Measures

Name	Time	Method
Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH)	Up to 5 years