NCT00457249

A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older

Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) in Persons ≥65 Years of Age

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,564 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication. The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.

Conditions

• Pertussis
• Tetanus
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed	0.5 mL, IM
BIOLOGICAL	DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed	0.5 mL, IM

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-09-01
• Completion: 2008-11-01
• First posted: 2007-04-06
• Last updated: 2012-10-19
• Results posted: 2012-10-19

Locations

19 sites across 1 country: United States