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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 21, 2014
Last verified: October 2014

February 27, 2010
October 21, 2014
February 2010
February 2015   (final data collection date for primary outcome measure)
Receipt of any pertussis vaccine confirmed by survey methods [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01079039 on ClinicalTrials.gov Archive Site
Not Provided
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Survey for Usage Rates of Pertussis Vaccines in the State of Wisconsin
Survey for Usage Rates of Pertussis Vaccines by Brand Among Persons Birth Through 59 Months of Age in the State of Wisconsin

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.

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.

Observational
Observational Model: Cohort
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Probability Sample

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

Pertussis
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Pertussis vaccine users
Participants who have received no more than four doses of pertussis vaccine and residing in the state of Wisconsin.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12000
June 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
2 Months to 59 Months
No
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com
United States
 
NCT01079039
M5A17, UTN: U1111-1112-2615
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP