Overview

This trial is active, not recruiting.

Condition pertussis
Treatments pentacel® (dtap-ipv/hib), other pertussis vaccines
Phase phase 4
Sponsor Sanofi Pasteur, a Sanofi Company
Start date May 2010
End date February 2015
Trial size 19172 participants
Trial identifier NCT01129362, M5A16, NCT01079039, UTN: U1111-1111-5171

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
Participants that only received Pentacel® vaccine.
pentacel® (dtap-ipv/hib) Pentacel®
0.5 mL dose, Intramuscular
Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine.
other pertussis vaccines DAPTACEL®
0.5 mL, Intramuscular
Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand.
other pertussis vaccines DAPTACEL®
0.5 mL, Intramuscular

Primary Outcomes

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

Eligibility Criteria

Male or female participants up to 59 months old.

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 :

Additional Information

Official title Surveillance for Rates of Pertussis Disease Among Persons Birth Through 59 Months of Age Receiving Pentacel® or Other Pertussis Vaccines
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Sanofi.