Database Surveillance Safety Study of PENTACEL® Vaccine

Completed

• Conditions: Diphtheria; Haemophilus Influenzae; Tetanus; Pertussis
• Interventions: Biological: DTaP-IPV/Hib; Biological: Other DTap Vaccines

• Registration Number: NCT00804284
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Primary Completion: 2014-08
• Study Completion: 2015-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62538

Inclusion Criteria

• Receipt of DTaP vaccine during the study period by a previously unvaccinated child

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pentacel Group	DTaP-IPV/Hib	Infants initiated on PENTACEL® vaccine
Other DTap vaccines Group	Other DTap Vaccines	Infants initiated on other DTaP vaccines

Primary Outcome Measures

Name	Time	Method
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).