Tetanus Clinical Trial
Official title:
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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