Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00437671
Recruitment Status : Terminated (Study terminated for cGCP non-compliance. Analyses could not be performed.)
First Posted : February 21, 2007
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Tetanus Drug: Tetanus Immune Globulin (Human) Biological: Diphtheria-Tetanus Toxoids Adsorbed Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : March 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus

Arm Intervention/treatment
Experimental: Entered study Drug: Tetanus Immune Globulin (Human)
Based on package insert recommendation and recommendations of WHO
Other Names:
  • HyperTET S/D
  • BayTet
  • BAY 19-8515
  • TAL-05-00013
  • NDC 13533-634-02

Biological: Diphtheria-Tetanus Toxoids Adsorbed
Based on package insert recommendations and recommendations of WHO

Primary Outcome Measures :
  1. Antibody titer serum level at each time point [ Time Frame: 40 days ]
  2. Cmax [ Time Frame: 40 days ]
  3. Tmax [ Time Frame: 40 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age between 18 and 90 years.
  • Signed a written informed consent prior to initiation of any study-related procedures.
  • No known primary immunization history with TT/dT or >10 years have passed since the last dose of tetanus containing vaccine was received. Subjects with unknown or uncertain previous vaccination histories are considered to have no previous tetanus and toxoid doses. Subjects who have had military service since 1941 will be considered to have had 1 dose of tetanus vaccine.
  • Subjects must have documented tetanus antibody levels that are non-protective levels (< 0.15 IU/ml).
  • Subjects must be free of any presenting wound or wound infection

Exclusion Criteria:

  • History or suspicion of significant allergic reaction to intravenous immune globulin, and or blood products
  • A history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA
  • Congestive heart failure (New York Association stage greater than Class II)
  • Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
  • Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
  • Subjects who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
  • TIG therapy within the previous six months
  • Investigational drug therapy within the previous three months
  • History of Thromboembolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00437671

United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Grifols Therapeutics LLC
Principal Investigator: Kumar Alagappan, MD Long Island Jewish Medical Center

Responsible Party: Grifols Therapeutics LLC Identifier: NCT00437671     History of Changes
Other Study ID Numbers: 060002
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Grifols Therapeutics LLC:

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs