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

Brief Title

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

Official Title

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.
    

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.
    


Study Type

Observational


Primary Outcome

The change from baseline in tetanus antibody titer at 4weeks, 6 months and 12months


Condition

Tetanus


Study Arms / Comparison Groups

 Td ,Td and TIG
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

250

Start Date

October 2008

Completion Date

October 2010

Primary Completion Date

April 2010

Eligibility Criteria

        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
      

Gender

All

Ages

20 Years - 89 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

JongHwan Shin, , 



Administrative Informations


NCT ID

NCT01338688

Organization ID

Td-TIG



Study Sponsor

Seoul National University Hospital

Collaborators

 Seoul National University Boramae Hospital

Study Sponsor

JongHwan Shin, Principal Investigator, Seoul National University Boramae Hospital


Verification Date

April 2011