Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents

Confirmatory Study to Evaluate the Immunogenicity of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP Vaccine, BK1301) as a Booster in Adolescents

This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents.

The purposes of this study are as follows:

• To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies
• To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301

Inclusion Criteria:

• Age 11 or 12 years on the day of injection
• Received 3 or 4 doses of DTaP vaccine

Exclusion Criteria:

• History of pertussis, diphtheria, tetanus
• History of anaphylaxis to vaccine components
• Serious conditions or diseases of the heart, vein, blood, respiratory, hepar, kidney, digestive system, psychiatric or nervous system
• Transfused or received gamma globulin within 3 months, or received high-dose gamma globulin within 6 months before the day of injection