Safety and immunogenicity of Biken acellular pertussis vaccine in combination with diphtheria and tetanus toxoid as a fifth dose at four to six years of age. Munich Vaccine Study Group.

Objectives: To evaluate the safety and immunogenicity of Biken acellular pertussis vaccine in combination with diphtheria and tetanus toxoid (Biken DTaP) vaccine administered to children 4 to 6 years of age who had previously received four doses of Biken DTaP.

Methods: 580 children were enrolled to receive one dose of Biken DTaP. Local and systemic reactions were collected by parent diary for all subjects within 3 days after vaccination and in a subset for 14 days.