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

Tetanus Clinical Trial

Official title:

the Change of the Tetanus Antibody Titer After Single Injection of Tetanus Vaccine and Simultaneous Injection of Tetanus Immunoglobulin With Tetanus Vaccine?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338688
• Other study ID #: Td-TIG
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: April 18, 2011
• Start date: October 2008
• Est. completion date: October 2010

Study information

• Verified date: April 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 89 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tetanus

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Boramae Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in tetanus antibody titer at 4weeks, 6 months and 12months	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.	Baseline, 4 weeks, 6 months, 12 months	Yes