CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3,651 enrolled
Drug / intervention
Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine +1 morebiological
Likely dose
Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00601835
NCT00601835Phase 4Completed

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

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jan 28, 2008·Updated Apr 14, 2016

In Brief

A Phase 4 clinical trial evaluating Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine for Diphtheria and Tetanus. Completed, enrolled 3,651 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartMay 1, 2004
Primary CompletionJul 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.4 years ago

Interventions

Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccinebiological

0.5 mL, Intramuscular, single dose

Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccinebiological

0.5 mL, Intramuscular, Single dose