NCT01338688

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
Last Updated

April 19, 2011

Status Verified

April 1, 2011

Enrollment Period

1.5 years

First QC Date

April 7, 2011

Last Update Submit

April 18, 2011

Conditions

Tetanus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Td ,Td and TIG

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy adult over twenty

You may qualify if:

  • healthy adult volunteers

You may not qualify if:

  • immunocompromised
  • febrile
  • allergy to the vaccine constituents
  • previous tetanus immunization within 5 years
  • medical and non-medical employees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • JongHwan Shin

    Seoul National University Boramae Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 19, 2011

Study Start

October 1, 2008

Primary Completion

April 1, 2010

Study Completion

October 1, 2010

Last Updated

April 19, 2011

Record last verified: 2011-04