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

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Boramae Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01338688
First received: April 7, 2011
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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.


Condition
Tetanus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: the Change of the Tetanus Antibody Titer After Single Injection of Tetanus Vaccine and Simultaneous Injection of Tetanus Immunoglobulin With Tetanus Vaccine?

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The change from baseline in tetanus antibody titer at 4weeks, 6 months and 12months [ Time Frame: Baseline, 4 weeks, 6 months, 12 months ] [ Designated as safety issue: Yes ]
    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.


Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 250
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Td ,Td and TIG

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.

  Eligibility

Ages Eligible for Study:   20 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy adult over twenty

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01338688

Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Boramae Hospital
Investigators
Principal Investigator: JongHwan Shin Seoul National University Boramae Hospital
  More Information

No publications provided

Responsible Party: Jong Hwan Shin, Seoul National University-Seoul Metropolitan Goverment Boramae Hospital
ClinicalTrials.gov Identifier: NCT01338688     History of Changes
Other Study ID Numbers: Td-TIG
Study First Received: April 7, 2011
Last Updated: April 18, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Tetanus
Tetany
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014