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

This is a multi-center, partially open-label, partially randomized double blind trial for
immunogenicity and safety in the United States. Participants will be enrolled to one of
three treatment groups:

- Subjects ages 11-59 years will receive Canadian manufactured Td vaccine on Day 0

- Subjects 60 years or older will be randomized to receive either US manufactured Td on
Day 0, or,

- Subjects 60 years or older randomized to receive Canadian manufactured Td on Day 0

The trial is designed to assess the safety of Canadian Manufactured Tetanus and Diphtheria
Toxoids Adsorbed vaccine in all trial participants 11 to 59 years of age and to describe the
immune responses in subsets of adolescents (11-14, and 15-18 years of age) and in a subset
of adults 19-59 years of age. The trial will also compare the immune responses and safety in
subjects ≥ 60 years of age receiving Canadian Manufactured Tetanus and Diphtheria Toxoids
Adsorbed vaccine to an equal number of subjects ≥ 60 years of age receiving US Manufactured
Tetanus and Diphtheria Toxoids Adsorbed vaccine.

Inclusion Criteria:

- Participant is healthy as per medical history reported by subject.

- Participant is at least 11 years of age at the time of vaccination.

- Participant has a signed Institutional Review Board (IRB)-approved informed
assent/consent form. For subjects 11 to 17 years of age, a written informed consent
must be obtained from parent(s) or legal guardian(s) and a written informed assent
must be obtained from the subject

- Participant provides history or documentation of primary or booster immunization with
Diphtheria and Tetanus.

- Female participants of childbearing potential must have a negative urine pregnancy
test at the time of enrollment.

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.