The Change of the Tetanus Antibody Titer After Single Injection of Td and Simultaneous Injection of TIG With Td
| Tracking Information | |||||
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| First Received Date ICMJE | April 7, 2011 | ||||
| Last Updated Date | April 18, 2011 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01338688 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Change of the Tetanus Antibody Titer After Single Injection of Td and Simultaneous Injection of TIG With Td | ||||
| Official Title ICMJE | the Change of the Tetanus Antibody Titer After Single Injection of Tetanus Vaccine and Simultaneous Injection of Tetanus Immunoglobulin With Tetanus Vaccine? | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: serum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | healthy adult over twenty |
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| Condition ICMJE | Tetanus | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Td ,Td and TIG | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 250 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 89 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01338688 | ||||
| Other Study ID Numbers ICMJE | Td-TIG | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jong Hwan Shin, Seoul National University-Seoul Metropolitan Goverment Boramae Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||
| Collaborators ICMJE | Seoul National University Boramae Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Seoul National University Hospital | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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