drugset / Trial / NCT00601835

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

NCT00601835 ↗

Phase 4 Completed 3651 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2004-05
Primary completion
2005-07
Completion
2005-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Vaccine 0.5 ml Intramuscular
Comparator Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Vaccine 0.5 ml Intramuscular

Indications