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

Completed

• Conditions: Tetanus

• Registration Number: NCT01338688
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2010-04
• Study Completion: 2010-10
• Status Verified: 2011-04
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-18
• Last Update Submitted: 2011-04-18
• Study First Posted: 2011-04-19
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change from baseline in tetanus antibody titer at 4weeks, 6 months and 12months	Baseline, 4 weeks, 6 months, 12 months	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.