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

NCT00437671 | Terminated Phase 4

• 1 other identifier: 060002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetanus

Keywords

trismus; lockjaw

Outcome Measures

Primary Outcomes (3)

• Antibody titer serum level at each time point

  40 days

• Cmax

  40 days

• Tmax

  40 days

Study Arms (1)

Entered study

EXPERIMENTAL

Drug: Tetanus Immune Globulin (Human); Biological: Diphtheria-Tetanus Toxoids Adsorbed

Interventions

Tetanus Immune Globulin (Human) DRUG

Based on package insert recommendation and recommendations of WHO

Also known as: HyperTET S/D, BayTet, BAY 19-8515, TAL-05-00013, NDC 13533-634-02

Entered study

Diphtheria-Tetanus Toxoids Adsorbed BIOLOGICAL

Based on package insert recommendations and recommendations of WHO

Entered study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grifols Therapeutics LLC: lead

Study Sites (1)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Tetanus; Trismus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kumar Alagappan, MD

  Long Island Jewish Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)