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

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.

Timeline

Start

2006-03

Primary completion

2006-10

Completion

2007-10

Publications

• Results Liese JG, Rieber N, Malzer T, Ocak M, Johnson DR, Decker MD; Munich Vaccine Study Group. Reactogenicity of tetanus, diphtheria, 5-component acellular pertussis vaccine administered as a sixth consecutive acellular pertussis vaccine dose to adolescents. Pediatr Infect Dis J. 2010 Dec;29(12):1067-71. doi: 10.1097/INF.0b013e3181ea5866.

Drugs

Indications