NCT00304265

Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine

Reactogenicity of Acellular Pertussis Vaccine Booster in Adolescents Who Have Received 5 Prior Doses of BIKEN Acellular Pertussis Vaccine in Combination With Diphtheria and Tetanus Toxoids (TRIPEDIA®) or Who Have Received Primary Vaccination With 3 Doses of Whole-Cell Pertussis Vaccine, Plus at Least 1 Pertussis Booster Vaccination

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

Summary

Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine. To describe and characterize adverse events occurring after vaccination with REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine among two groups: Group 1 - adolescents 10-14 years of age who participated in study 371-03/01 (and thus received a 5th dose of TRIPEDIA® vaccine) and Group 2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life.

Conditions

• Pertussis
• Diphtheria
• Tetanus
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)	0.5 mL, Intramuscular

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-10-01
• Completion: 2007-10-01
• First posted: 2006-03-17
• Last updated: 2016-04-14
• Results posted: 2011-04-07

Locations

17 sites across 1 country: Germany