NCT00601835

Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td

Immunogenicity and Safety of Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) for Adult Use Vaccine Compared With U.S. Manufactured Tetanus and Diphtheria Toxoids Adsorbed for Adult Use Vaccine In Persons 60 Years of Age and Older and Immunogenicity and Safety of Canadian Td Vaccine in Persons 11 Through 59 Years of Age

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,651 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 11 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age. To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age.

Detailed description

This is a multi-center, partially open-label, partially randomized double blind trial for immunogenicity and safety in the United States. Participants will be enrolled to one of three treatment groups: * Subjects ages 11-59 years will receive Canadian manufactured Td vaccine on Day 0 * Subjects 60 years or older will be randomized to receive either US manufactured Td on Day 0, or, * Subjects 60 years or older randomized to receive Canadian manufactured Td on Day 0 The trial is designed to assess the safety of Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in all trial participants 11 to 59 years of age and to describe the immune responses in subsets of adolescents (11-14, and 15-18 years of age) and in a subset of adults 19-59 years of age. The trial will also compare the immune responses and safety in subjects ≥ 60 years of age receiving Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to an equal number of subjects ≥ 60 years of age receiving US Manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine.

Conditions

• Diphtheria
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine	0.5 mL, Intramuscular, single dose
BIOLOGICAL	Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine	0.5 mL, Intramuscular, Single dose

Timeline

• Start date: 2004-05-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2008-01-28
• Last updated: 2016-04-14
• Results posted: 2011-02-18

Locations

2 sites across 1 country: United States