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

NCT00804284 COMPLETED

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.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Status	COMPLETED
Enrolment	62538
Start date	2008-09
Completion	2015-01

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Haemophilus Influenzae

Interventions

• DTaP-IPV/Hib
• Other DTap Vaccines

Primary outcomes

• A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review. — 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).

Countries

United States