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

Sanofi

Status: Completed

Conditions: Pertussis

Treatments: Biological: Pentacel® (DTaP-IPV/Hib); Biological: Other Pertussis Vaccines

Study type: Observational

Funder types: Industry

Identifiers

NCT01129362

UTN: U1111-1111-5171 (Other Identifier)

M5A16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,195 patients

Sex: All

Ages: Under 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,195 participants in 3 patient groups

Group 1

Description:

Participants that only received Pentacel® vaccine.

Treatment:

Biological: Pentacel® (DTaP-IPV/Hib)

Group 2

Description:

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

Treatment:

Biological: Other Pertussis Vaccines

Group 3

Description:

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

Treatment:

Biological: Other Pertussis Vaccines