Clinical trial NCT00258882: Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine
Official title: Post-licensure Safety Surveillance Study of Routine Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis
Keywords: Tetanus Toxoid,
acellular pertussis,
diphtheria toxoid
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 327293
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Passive surveillance by review of Kaiser Permanente Medical Care Program (KPMCP) computerized records and state mortality tapes

Brief summary: 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.

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 criteria: Inclusion Criteria:

* Receipt of ADACEL vaccine during the study period

Exclusion Criteria:

* None

Primary outcomes:
measure: Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database
timeFrame: Days 0 to 60 and Day 61 to 120 following vaccination
measure: Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database
timeFrame: Days 0 up to 180 following vaccination
measure: All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.
timeFrame: Days 0 to 60 and Day 61 to 120 following vaccination
measure: All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.
timeFrame: Days 0 to 180 following vaccination
measure: Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls
timeFrame: Pregnancy to Delivery, up to 9 months
measure: Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls.
timeFrame: Pregnancy to Delivery, up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Portland
country: United States
state: Oregon
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Baxter R, Hansen J, Timbol J, Pool V, Greenberg DP, Johnson DR, Decker MD. Post-licensure safety surveillance study of routine use of tetanus toxoid, reduced diphtheria toxoid and 5-component acellular pertussis vaccine. Hum Vaccin Immunother. 2016 Nov;12(11):2742-2748. doi: 10.1080/21645515.2016.1201622. Epub 2016 Jul 7.