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NCT00437671
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
Phase 4 trial testing Tetanus Immune Globulin (Human) in Tetanus in 6 participants. Terminated before completion.
1 September 2007
Quick facts
| Lead sponsor | Grifols Therapeutics LLC |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 6 |
| Start date | 1 March 2007 |
| Primary completion | 1 September 2007 |
| Estimated completion | 1 September 2007 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tetanus Immune Globulin (Human) — full drug profile →
- Diphtheria-Tetanus Toxoids Adsorbed — full drug profile →
Conditions studied
- Tetanus — all drugs for Tetanus →
Sponsor
Grifols Therapeutics LLC — full company profile →
Who can join
Adults 18 to 90, any sex, with Tetanus. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Antibody titer serum level at each time point
Time frame: 40 days -
Cmax
Time frame: 40 days -
Tmax
Time frame: 40 days
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00437671
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Tetanus
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT07107932 — A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury · recruiting
- NCT06708286 — A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component) · Phase 2, PHASE3 · active not recruiting
- NCT06635798 — A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR20 · Phase 3 · recruiting
- NCT06184542 — Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine · Phase 1 · recruiting
Other Grifols Therapeutics LLC trials
Trials by the same sponsor.
- NCT04722887 — A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subc · Phase 1, PHASE2 · completed
- NCT04847141 — A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients · Phase 3 · terminated
- NCT04547140 — Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants Wit · Phase 2 · terminated
- NCT04566692 — A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Tre · Phase 4 · completed
- NCT04480424 — Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatmen · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00437671 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Grifols Therapeutics LLC
- Last refreshed: 18 January 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00437671.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing