Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td
Condition: Diphtheria; Tetanus
MeSH terms: Tetanus; Diphtheria; Tetany
Intervention: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine; Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
Intervention description: 0.5 mL, Intramuscular, single dose; 0.5 mL, Intramuscular, Single dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3651.0
Sex: All
Minimum age: 11 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus

Summary:

      To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus
      and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to
      the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to
      subjects ≥ 60 years of age.

      To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian
      manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to
      the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to
      subjects ≥ 60 years of age.
    

Eligibility criteria:

        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.