Study of Adacel® Vaccine Administered to Persons 10 Years of Age

Summary

The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age. Primary Objectives: * To compare pertussis antibody responses induced by Adacel® in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. Secondary Objective: * To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.

Timeline

Start

2011-03

Primary completion

2011-11

Completion

2012-01

Publications

• Marshall GS, Pool V, Greenberg DP, Johnson DR, Sheng X, Decker MD. Safety and immunogenicity of tetanus-diphtheria-acellular pertussis vaccine administered to children 10 or 11 years of age. Clin Vaccine Immunol. 2014 Nov;21(11):1560-4. doi: 10.1128/CVI.00474-14. Epub 2014 Sep 17.

Drugs

Indications