Tetanus Clinical Trial
Official title:
Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) Given Intramuscularly Compared to Diphtheria and Tetanus Toxoids Adsorbed (DT) Given Subcutaneously in Japanese Adolescents 11 - 12 Years of Age
The aim of the study is to generate additional safety and immunogenicity data to support the
registration of the product in Japan.
Primary objectives:
- To demonstrate the non-inferiority of SP306 versus DT (DT BIK® 0.1mL) vaccine in terms
of diphtheria and tetanus booster response rate (proportion of subjects with booster
responses) and seroprotection rate (percentage of subjects with antitoxin
concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in
Japanese adolescents 11-12 years of age.
- To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in
terms of booster response rate (proportion of subjects with booster responses) at 28
days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of
age.
Secondary objectives:
- To further evaluate the immune response of the study vaccines against diphtheria,
tetanus and pertussis antigens.
- To assess the safety of the study vaccines after one injection in Japanese adolescents
11-12 years of age.
Study participants will receive either a single dose of SP306 vaccine intramuscularly or a dose of DT BIK® vaccine subcutaneously. They will be monitored after vaccination for immediate adverse events (AEs) solicited injection site and systemic reactions and unsolicited AEs including serious adverse events throughout the study period, approximately 28 days (+7 days). ;
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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