Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td

Exclusion Criteria

• •Serious and uncontrolled chronic disease (i.e., cardiac, pulmonary, renal, neurologic, metabolic, rheumatologic, etc.).
• •Known or suspected impairment of immunologic function.
• •Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment.
• •Administration of immune globulin or other blood products within the last three months; administration of corticosteroids (injected or oral) or other immunomodulatory therapy within six weeks of the study vaccine. However, individuals on a tapering dose schedule of oral steroids may be included in the trial, as long as steroids were discontinued more than two weeks prior to enrollment.
• •Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccination, other than influenza prior to Visit 2 blood draw. For influenza vaccine only, exclude if received in the 14 day period prior to enrollment or scheduled to receive in the 14 day period after Visit 1.
• •Suspected or known hypersensitivity to Td components, thimerosal (for subjects \> 60 years of age) or latex rubber.
• •Unable to attend scheduled visits or unable to comply with the study procedures.
• •Enrolled in another clinical trial.
• •Any condition that would pose a health risk to the participant or interfere with the evaluation of the vaccine in the opinion of the investigator.
• •A positive urine pregnancy test at the time of enrollment for all females of childbearing potential.
• •Female of childbearing potential who does not agree either to remain abstinent or to use effective birth control during the period of the trial.
• •Breast feeding during the period of the trial.
• •A history of Guillain- Barré syndrome within 6 weeks after a previous dose of a tetanus toxoid-containing vaccine.
• •Receipt of a tetanus or diphtheria vaccination within the 5 years prior to enrollment.
• •A previous history of diphtheria disease within the last 25 years or tetanus disease
• •History of Arthus-type hypersensitivity reaction or a temperature \>103° F following a prior dose of tetanus toxoid, unless 10 years have elapsed since the previous dose.