The Change of the Tetanus Antibody Titer After Single Injection of Td and Simultaneous Injection of TIG With Td

NCT ID: NCT01338688

Last Updated: 2011-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tetanus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Td ,Td and TIG

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Boramae Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University-Seoul Metropolitan Goverment Boramae Hospital

Principal Investigators

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JongHwan Shin

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Boramae Hospital

Other Identifiers

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Td-TIG

Identifier Type: -

Identifier Source: org_study_id

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