NCT00712959

Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

Immune Responses in Adults to Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 769 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus. Primary Objective: * To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.

Detailed description

This is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.

Conditions

• Pertussis
• Tetanus
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)	0.5 ml, IM
BIOLOGICAL	Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)	0.5 mL, IM

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2008-07-10
• Last updated: 2014-04-30
• Results posted: 2014-04-30

Locations

7 sites across 1 country: Canada