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Sponsored by: |
Talecris Biotherapeutics |
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Information provided by: | Talecris Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT00437671 |
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given concurrently with strict control on the anatomical location and timing of administration of TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate titer protection provided by TIG and TT given in combination will be assessed using a standardized administration regimen and standardized antibody assay procedure. This study may provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage for anyone with the potential of developing tetanus.
Condition | Intervention | Phase |
---|---|---|
Tetanus |
Drug: Tetanus Immune Globulin (Human) Biological: Diphtheria-Tetanus Toxoids Adsorbed |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetics Of Active And Passive Tetanus Immunization Given Concurrently In Subjects With No Known Primary Immunization History Or In Subjects With Tetanus Antibody Levels Below Protective Levels |
Enrollment: | 6 |
Study Start Date: | March 2007 |
Study Completion Date: | September 2007 |
Arms | Assigned Interventions |
---|---|
Entered study: Experimental | Drug: Tetanus Immune Globulin (Human) Biological: Diphtheria-Tetanus Toxoids Adsorbed |
This is a prospective, open-label, single-center trial including a single group of subjects with no known primary immunization history with TT or >10 years have passed since the last dose of tetanus containing vaccine was received. The study will enroll six subjects who will receive both dT and TIG concurrently on Day 1.
All dosed subjects will be followed for 40 days during which Day 1, 2, 3, 4, 5, 7, 14, 21, 30 and 40 time levels of tetanus antibodies will be measured in order to determine the serum level vs. time curve, Cmax, Tmax, and duration of protective antibody levels.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 |
Principal Investigator: | Kumar Alagappan, MD | Long Island Jewish Medical Center |
Study ID Numbers: | 060002 |
Study First Received: | February 20, 2007 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00437671 |
Health Authority: | United States: Institutional Review Board |
trismus lockjaw |
Bacterial Infections Antibodies Gram-Positive Bacterial Infections Trismus |
Clostridium Infections Tetanus Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |