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

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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Key information

Conditions

Tetanus Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

Seoul National University Boramae Hospital

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Apr 19, 2011
Registry last updated: Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed