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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129362
First Posted: May 24, 2010
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  Purpose

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.


Condition Intervention
Pertussis Biological: Pentacel® (DTaP-IPV/Hib) Biological: Other Pertussis Vaccines

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Surveillance for Rates of Pertussis Disease Among Persons Birth Through 59 Months of Age Receiving Pentacel® or Other Pertussis Vaccines

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH) [ Time Frame: Up to 5 years ]

Enrollment: 19172
Actual Study Start Date: May 2010
Study Completion Date: December 30, 2014
Primary Completion Date: December 30, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Participants that only received Pentacel® vaccine.
Biological: Pentacel® (DTaP-IPV/Hib)
0.5 mL dose, Intramuscular
Other Name: Pentacel®
Group 2
Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine.
Biological: Other Pertussis Vaccines
0.5 mL, Intramuscular
Other Names:
  • DAPTACEL®
  • Tripedia®
  • TriHIBit®
  • Infanrix®
  • Pediarix®
Group 3
Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand.
Biological: Other Pertussis Vaccines
0.5 mL, Intramuscular
Other Names:
  • DAPTACEL®
  • Tripedia®
  • TriHIBit®
  • Infanrix®
  • Pediarix®

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Wisconsin residents younger than 60 months of age.
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 :

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129362


Locations
United States, Wisconsin
Madison, Wisconsin, United States, 53701-2659
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01129362     History of Changes
Obsolete Identifiers: NCT01079039
Other Study ID Numbers: M5A16
UTN: U1111-1111-5171 ( Other Identifier: WHO )
First Submitted: May 20, 2010
First Posted: May 24, 2010
Last Update Posted: June 29, 2017
Last Verified: June 2017

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Pertussis
Whooping Cough
Pertussis Vaccine

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs