NCT00804284

Database Surveillance Safety Study of PENTACEL® Vaccine

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62,538 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: Male
• Age: 6 Weeks – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Haemophilus Influenzae

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV/Hib	0.5 mL, Intramuscular
BIOLOGICAL	Other DTap Vaccines	0.5 mL, Intramuscular

Timeline

• Start date: 2008-09-01
• Primary completion: 2014-08-01
• Completion: 2015-01-01
• First posted: 2008-12-08
• Last updated: 2015-08-19

Locations

1 site across 1 country: United States