Trial record 3 of 251 for:    "Whooping cough"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01129362
First received: May 20, 2010
Last updated: May 19, 2014
Last verified: May 2014
  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 Phase
Pertussis
Biological: Pentacel® (DTaP-IPV/Hib)
Biological: Other Pertussis Vaccines
Phase 4

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:

Primary Outcome Measures:
  • Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 68000
Study Start Date: May 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   up to 59 Months
Genders Eligible for Study:   Both
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 :

  • 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: NCT01129362

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

Locations
United States, Wisconsin
Recruiting
Madison, Wisconsin, United States, 53792
Recruiting
Madison, Wisconsin, United States, 53701-2659
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: NCT01129362     History of Changes
Other Study ID Numbers: M5A16, UTN: U1111-1111-5171
Study First Received: May 20, 2010
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
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

ClinicalTrials.gov processed this record on September 22, 2014