Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00258882
First received: November 24, 2005
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.


Condition Intervention Phase
Pertussis
Biological: Tetanus Toxoid, acellular pertussis, diphtheria toxoid
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Post-licensure Safety Surveillance Study of Routine Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Other Outcome Measures:
  • Summary of the vaccine safety profile including signals of potentially vaccine-related adverse events. [ Time Frame: Up to 6 months post-vaccination ] [ Designated as safety issue: No ]
    Medical encounter, emergency room, hospitalization, laboratory, and related databases will be reviewed to identify all medical care events at Kaiser Permanente Medical Care Program (KPMCP) for vaccinees for the 6-month period following vaccination. State death reports will also be reviewed.


Enrollment: 12020
Study Start Date: January 2006
Study Completion Date: December 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Tetanus Toxoid, acellular pertussis, diphtheria toxoid
    0.5 mL, Intramuscular
    Other Name: Adacel®
Detailed Description:

Surveillance using a healthcare organization with large comprehensive medical encounter databases will be used in this study to identify any risks or uncommon events associated with use of the recently licensed Adacel vaccine that may occur in routine clinical usage in a large population.

No investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Adacel vaccine as part of routine care.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Passive surveillance by review of Kaiser Permanente Medical Care Program (KPMCP) computerized records and state mortality tapes

Criteria

Inclusion Criteria:

  • Receipt of ADACEL vaccine during the study period

Exclusion Criteria:

  • None
  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: NCT00258882

Locations
United States, California
Oakland, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Oregon
Portland, Oregon, United States
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00258882     History of Changes
Other Study ID Numbers: TD512
Study First Received: November 24, 2005
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Tetanus Toxoid,
acellular pertussis,
diphtheria toxoid

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