NCT02089347

Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 534 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 11 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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 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.

Detailed description

Study participants will receive either a single dose of SP306 vaccine intramuscularly or a dose of DT 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).

Conditions

• Tetanus
• Diphtheria
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed	0.5 mL, intramuscularly.
BIOLOGICAL	Diphtheria and Tetanus toxoids adsorbed	0.1 mL, Subcutaneously

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-09-01
• Completion: 2015-03-01
• First posted: 2014-03-17
• Last updated: 2017-05-30
• Results posted: 2015-10-08

Locations

19 sites across 1 country: Japan