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

Pertussis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129362
• Other study ID #: M5A16
• Secondary ID: UTN: U1111-1111-
• Status: Completed
• Start date: February 8, 2010
• Est. completion date: December 30, 2014

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01079039

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1195
• Est. completion date: December 30, 2014
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

Biological:
• Pentacel® (DTaP-IPV/Hib)
0.5 mL dose, Intramuscular
• Other Pertussis Vaccines
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH)		Up to 5 years