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

Brief Title

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

Official Title

Immunogenicity and Safety of Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) for Adult Use Vaccine Compared With U.S. Manufactured Tetanus and Diphtheria Toxoids Adsorbed for Adult Use Vaccine In Persons 60 Years of Age and Older and Immunogenicity and Safety of Canadian Td Vaccine in Persons 11 Through 59 Years of Age

Brief 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.
    

Detailed Description

      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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.

Secondary Outcome

 Post-vaccination Geometric Mean Titer (GMT) to Tetanus and Diphtheria in Participants ≥ 60 Years Vaccinated With Canadian-manufactured or US-manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.

Condition

Diphtheria

Intervention

Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine

Study Arms / Comparison Groups

 Canadian Td Vaccine Group
Description:  Participants received Canadian manufactured Td vaccine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

3651

Start Date

May 2004

Completion Date

July 2005

Primary Completion Date

July 2005

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.
      

Gender

All

Ages

11 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00601835

Organization ID

TDC01


Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company


Study Sponsor

Medical Director, Study Director, Sanofi Pasteur Inc.


Verification Date

April 2016