Post-Licensure Safety Surveillance Study of Routine Use of PENTACEL® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diphtheria
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 62538
- Primary Endpoint
- A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
Detailed Description
The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization. Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Receipt of DTaP vaccine during the study period by a previously unvaccinated child
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
Time Frame: Up to 6 months post -dose 4 DTap Vaccination
Outcome of interest identified from Kaiser Permanente Medical Care Program (KPMCP) computerized records via International Classification of Diseases, 9th edition (ICD-9) codes, defined as: * Death, * Outpatient clinic visit for: * seizure occurring within 72 hours of vaccination, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness (other than secondary to another diagnosis), or meningitis * hypersensitivity reactions (e.g. urticaria, angioedema, or anaphylaxis) occurring within 72 hours of vaccination, * new-onset autoimmune disease (including idiopathic thrombocytopenic purpura, hemolytic anemia).