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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00601835 |
To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed to the seroprotection rates and booster responses to the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed 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 to the post-vaccination GMTs to the US manufactured Tetanus and Diphtheria Toxoids Adsorbed when administered to subjects >-60 years of age.
Condition | Intervention | Phase |
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Diphtheria Tetanus |
Biological: TENIVAC™ Biological: DECAVAC® |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 3651 |
Study Start Date: | May 2004 |
Study Completion Date: | July 2005 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: TENIVAC™
0.5 ML, single dose
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2: Active Comparator |
Biological: DECAVAC®
0.5 ML, Single dose
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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:
The trial is designed to describe the safety of Canadian 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 Tetanus and Diphtheria Toxoids Adsorbed vaccine to an equal number of subjects > 60 years of age receiving US Tetanus and Diphtheria Toxoids Adsorbed vaccine.
Ages Eligible for Study: | 11 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur, Inc ( Medical Director ) |
Study ID Numbers: | TDC01 |
Study First Received: | January 15, 2008 |
Last Updated: | January 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00601835 |
Health Authority: | United States: Food and Drug Administration |
Diphtheria Tetanus |
Bacterial Infections Gram-Positive Bacterial Infections Diphtheria Clostridium Infections Tetanus |
Corynebacterium Infections Actinomycetales Infections |