NCT01129362

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,195 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 59 Months
• Healthy volunteers: Accepted

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.

Conditions

• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Pentacel® (DTaP-IPV/Hib)	0.5 mL dose, Intramuscular
BIOLOGICAL	Other Pertussis Vaccines	0.5 mL, Intramuscular

Timeline

• Start date: 2010-02-08
• Primary completion: 2014-12-30
• Completion: 2014-12-30
• First posted: 2010-05-24
• Last updated: 2022-04-25

Locations

2 sites across 1 country: United States