Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
Terminated
Grifols Therapeutics Inc.
Phase 4
2007-03-01
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when
Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given
concurrently with strict control on the anatomical location and timing of administration of
TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate
titer protection provided by TIG and TT given in combination will be assessed using a
standardized administration regimen and standardized antibody assay procedure. This study may
provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual
coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage
for anyone with the potential of developing tetanus.
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
Terminated
Grifols Therapeutics LLC
Phase 4
2007-03-01
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when
Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given
concurrently with strict control on the anatomical location and timing of administration of
TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate
titer protection provided by TIG and TT given in combination will be assessed using a
standardized administration regimen and standardized antibody assay procedure. This study may
provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual
coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage
for anyone with the potential of developing tetanus.
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