Survey for Usage Rates of Pertussis Vaccines in the State of Wisconsin

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01079039
First received: February 27, 2010
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine during the course of 5 years, the patterns of pertussis vaccine usage by brand and dose among children birth through 59 months of age who have received no more than four doses of pertussis vaccine, residing in the state of Wisconsin.

The state of Wisconsin conducts comprehensive surveillance for pertussis disease. Data from this brand exposure survey will be used to determine brand-specific rates of pertussis disease among Wisconsin residents birth through 59 months of age.


Condition Phase
Pertussis
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Survey for Usage Rates of Pertussis Vaccines by Brand Among Persons Birth Through 59 Months of Age in the State of Wisconsin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Receipt of any pertussis vaccine confirmed by survey methods [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 12000
Study Start Date: February 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pertussis vaccine users
Participants who have received no more than four doses of pertussis vaccine and residing in the state of Wisconsin.

Detailed Description:

This study supports the fulfillment of a post-licensure commitment to monitor vaccine-specific rates of pertussis breakthrough disease among children given Pentacel vaccine or other pertussis vaccines.

Ongoing telephone sample surveys will (with parental consent) collect brand-specific pertussis vaccine/dosing information from health care providers of children living in the catchment area.

These brand exposure data will be used, along with pertussis surveillance data, to satisfy an FDA commitment to calculate brand-specific rates of pertussis disease during the study period among persons birth through 59 months of age residing in Wisconsin.

No vaccines will be provided or administered for this study.

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants who have received no more than four doses of pertussis vaccine and residing in the state of Wisconsin.

Criteria

Inclusion Criteria :

  • Persons will be eligible for inclusion in the survey population for this brand usage study whenever the following three conditions are true: the individual resides in Wisconsin, is age 2 through 59 months, and the date is within the 5-year survey period

Exclusion Criteria :

  • Not applicable.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079039

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

Locations
United States, Wisconsin
Recruiting
Appleton, Wisconsin, United States
Recruiting
Bear Creek, Wisconsin, United States
Recruiting
Eau Claire, Wisconsin, United States
Recruiting
Fairchild, Wisconsin, United States
Recruiting
Grand Rapids, Wisconsin, United States
Recruiting
Green Bay, Wisconsin, United States
Recruiting
Greenfield, Wisconsin, United States
Recruiting
Janesville, Wisconsin, United States
Recruiting
Kenosha, Wisconsin, United States
Recruiting
Madison, Wisconsin, United States
Recruiting
Maple Bluff, Wisconsin, United States
Recruiting
Milton, Wisconsin, United States
Recruiting
Milwaukee, Wisconsin, United States
Recruiting
Oshkosh, Wisconsin, United States
Recruiting
Racine, Wisconsin, United States
Recruiting
Rochester, Wisconsin, United States
Recruiting
Twin Lakes, Wisconsin, United States
Recruiting
Waukesha, Wisconsin, United States
Recruiting
Willow Springs, Wisconsin, United States
Recruiting
Winnebago, Wisconsin, United States
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01079039     History of Changes
Other Study ID Numbers: M5A17, UTN: U1111-1112-2615
Study First Received: February 27, 2010
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Pertussis
Pertussis vaccine

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014