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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00712959 |
The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus.
Primary Objective:
Condition | Intervention | Phase |
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Pertussis Tetanus Diphtheria |
Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immune Responses in Adults to Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose |
Estimated Enrollment: | 900 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Received Tdap or Tdap-IPV in a previous study
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Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 ml, IM
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2: Active Comparator
Tdap-naïve but a previous tetanus, diphtheria and/or pertussis dose.
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Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 mL, IM
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3: No Intervention |
This is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Canada, British Columbia | |
Coquitlam, British Columbia, Canada, V3C 4J2 | |
Vancouver, British Columbia, Canada, V6H 3V4 | |
Surrey, British Columbia, Canada, V3R 8P8 | |
Canada, Nova Scotia | |
Halifax, Nova Scotia, Canada, B3K 6R8 | |
Canada, Quebec | |
Pierrefonds, Quebec, Canada, H9H 4Y6 |
Study Director: | Emilia Jordanov, MD | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | TD526 |
Study First Received: | July 7, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00712959 History of Changes |
Health Authority: | Canada: Health Canada |
Pertussis Tetanus Diphtheria |
Acellular pertussis ADACEL®, Tdap vaccine |
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Cough |
Whooping Cough Diphtheria Clostridium Infections Tetanus Gram-Negative Bacterial Infections |
Bacterial Infections Whooping Cough Diphtheria Tetanus Infection Actinomycetales Infections Gram-Negative Bacterial Infections |
Bordetella Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Corynebacterium Infections Clostridium Infections |