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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01129362
Enrollment
1195
Registered
2010-05-24
Start date
2010-02-08
Completion date
2014-12-30
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis

Keywords

Pertussis, Whooping Cough, Pertussis Vaccine

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.

Interventions

BIOLOGICALPentacel® (DTaP-IPV/Hib)

0.5 mL dose, Intramuscular

BIOLOGICALOther Pertussis Vaccines

0.5 mL, Intramuscular

Sponsors

Sanofi Pasteur, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 59 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026