Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437671
Status:
TERMINATED
Last Update Posted:
2016-01-20
First Post:
2007-02-20
Brief Title:
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
Sponsor:
Grifols Therapeutics LLC
Organization:
Grifols Therapeutics LLC
Study Overview
Official Title:
Pharmacokinetics Of Active And Passive Tetanus Immunization Given Concurrently In Subjects With No Known Primary Immunization History Or In Subjects With Tetanus Antibody Levels Below Protective Levels
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated for cGCP non-compliance Analyses could not be performed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when Tetanus Immune Globulin HumanTIG 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
Detailed Description:
This is a prospective open-label single-center trial including a single group of subjects with no known primary immunization history with TT or 10 years have passed since the last dose of tetanus containing vaccine was received The study will enroll six subjects who would receive both dT and TIG concurrently on Day 1
All dosed subjects will be followed for 40 days during which Day 1 2 3 4 5 7 14 21 30 and 40 time levels of tetanus antibodies will be measured in order to determine the serum level vs time curve Cmax Tmax and duration of protective antibody levels
All dosed subjects will be followed for 40 days during which Day 1 2 3 4 5 7 14 21 30 and 40 time levels of tetanus antibodies will be measured in order to determine the serum level vs time curve Cmax Tmax and duration of protective antibody levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None