NCT01311557

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

Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,302 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 10 Years – 11 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study participants will receive a single dose of study vaccine and will then be monitored for safety from the day of vaccination for up to 30 days post-vaccination.

Conditions

• Tetanus
• Diphtheria
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed	0.5 mL, Intramuscular
BIOLOGICAL	Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed	0.5 mL, Intramuscular

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-11-01
• Completion: 2012-01-01
• First posted: 2011-03-09
• Last updated: 2016-04-08
• Results posted: 2016-04-08

Locations

34 sites across 1 country: United States