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Tdap: Tetanus toxoid

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

Ensayo de Sanofi en Tetanus · Diphtheria · Pertussis (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

534

previstos

Centros

19

Fin del objetivo primario

sep 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2014.

Qué mide

Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT (Day 28 post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

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Ficha completa en ClinicalTrials.gov (NCT02089347), actualizada en abr 2017.