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NCT00437671 · ClinicalTrials.gov registry record · Phase 4
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
A Phase 4 study, sponsored by Grifols Therapeutics.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT00437671: Clinical Trial Phase 4 study, sponsored by Grifols Therapeutics.
NCT00437671 is a Phase 4 study that was terminated before completion, run by Grifols Therapeutics. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00437671, a Phase 4 study, was terminated before completion, sponsored by Grifols Therapeutics.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Tetanus Immune Globulin (Human)
- BIOLOGICAL Diphtheria-Tetanus Toxoids Adsorbed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-09 |
| Phase | Phase 4 |
Why NCT00437671 stopped before completion
NCT00437671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Tetanus Immune Globulin (Human) is the first listed.
NCT00437671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00437671 about?
NCT00437671 is a clinical study titled "Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels". 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 p...
What is the current status of trial NCT00437671?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2007-03. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00437671?
The interventions under investigation include: Tetanus Immune Globulin (Human) (DRUG), Diphtheria-Tetanus Toxoids Adsorbed (BIOLOGICAL).
Who is sponsoring clinical trial NCT00437671?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00437671's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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