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

NCT01129362 | Completed

• 2 other identifiers: M5A16UTN: U1111-1111-5171
• Study Type: observational
• Target: 1,195
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pertussis

Keywords

Pertussis; Whooping Cough; Pertussis Vaccine

Outcome Measures

Primary Outcomes (1)

• Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH)

  Up to 5 years

Study Arms (3)

Group 1

Participants that only received Pentacel® vaccine.

Biological: Pentacel® (DTaP-IPV/Hib)

Group 2

Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine.

Biological: Other Pertussis Vaccines

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

Interventions

Pentacel® (DTaP-IPV/Hib) BIOLOGICAL

0.5 mL dose, Intramuscular

Also known as: Pentacel®

Group 1

Other Pertussis Vaccines BIOLOGICAL

0.5 mL, Intramuscular

Also known as: DAPTACEL®, Tripedia®, TriHIBit®, Infanrix®, Pediarix®

Group 2; Group 3

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Wisconsin residents younger than 60 months of age.

You may qualify if:

• 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).

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Madison, Wisconsin, 53701-2659, United States

Location

Unknown Facility

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Conway JH, Davis JP, Eickhoff JC, Pool V, Greenberg DP, Decker MD. Brand-specific rates of pertussis disease among Wisconsin children given 1-4 doses of pertussis Vaccine, 2010-2014. Vaccine. 2020 Oct 21;38(45):7063-7069. doi: 10.1016/j.vaccine.2020.09.016. Epub 2020 Sep 11.

  PMID: 32921507 DERIVED

• Decker MD, Hosbach P, Johnson DR, Pool V, Greenberg DP. Estimating the effectiveness of tetanus-diphtheria-acellular pertussis vaccine. J Infect Dis. 2015 Feb 1;211(3):497-8. doi: 10.1093/infdis/jiu477. Epub 2014 Aug 25. No abstract available.

  PMID: 25156560 DERIVED

MeSH Terms

Conditions

Whooping Cough

Interventions

pentacel; diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine; Diphtheria-Tetanus-acellular Pertussis Vaccines; diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine; PEDIARIX

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 24, 2010
• Study Start: February 8, 2010
• Primary Completion: December 30, 2014
• Study Completion: December 30, 2014
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)