The Change of the Tetanus Antibody Titer After Single Injection of Td and Simultaneous Injection of TIG With Td
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Purpose
The investigators want to determine whether TIG influences the formation of tetanus antibody after simultaneous tetanus vaccination according to age and the time-interval of the last tetanus vaccination.
| Condition |
|---|
|
Tetanus |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | the Change of the Tetanus Antibody Titer After Single Injection of Tetanus Vaccine and Simultaneous Injection of Tetanus Immunoglobulin With Tetanus Vaccine? |
- The change from baseline in tetanus antibody titer at 4weeks, 6 months and 12months [ Time Frame: Baseline, 4 weeks, 6 months, 12 months ] [ Designated as safety issue: Yes ]The tetanus antibody titers were determined by ELISA and the results were reported in IU/mL. The measurement of tetanus antibody titer at 4 weeks should be needed to check the peak titer after vaccination. the change of tetanus antibody titers were calculated by geometric mean titers(GMTs), and we compared the GMTs between the groups(Td vs Td-TIG)at baseline, 4weeks, 6months, and 12 months by independent T-test.
Biospecimen Retention: Samples Without DNA
serum
| Enrollment: | 250 |
| Study Start Date: | October 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Td ,Td and TIG |
Detailed Description:
When an injured patient visits the ED, unnecessary injection of tetanus immunoglobulin (TIG) may cause side effects and also increase the medical expense.5 Further, the opportunity of assessing a rising tetanus antibody titer may be missed after simultaneous injection of tetanus-diphtheria vaccine (Td) and TIG. According to age, the elevation of the tetanus antibody titer after tetanus prophylaxis might be not equivalent because of different levels of basal immunity and the time-interval of the last tetanus vaccination. Therefore, we wanted to determine whether TIG influences the formation of tetanus antibody after simultaneous tetanus vaccination according to age and the time-interval of the last tetanus vaccination.
Eligibility| Ages Eligible for Study: | 20 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
healthy adult over twenty
Inclusion Criteria:
- healthy adult volunteers
Exclusion Criteria:
- immunocompromised
- febrile
- allergy to the vaccine constituents
- previous tetanus immunization within 5 years
- medical and non-medical employees
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jong Hwan Shin, Seoul National University-Seoul Metropolitan Goverment Boramae Hospital |
| ClinicalTrials.gov Identifier: | NCT01338688 History of Changes |
| Other Study ID Numbers: | Td-TIG |
| Study First Received: | April 7, 2011 |
| Last Updated: | April 18, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Tetanus Tetany Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Neuromuscular Manifestations |
Neurologic Manifestations Nervous System Diseases Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013