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

April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3651

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94611
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 56 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canadian Td Vaccine Group
Participants received Canadian manufactured Td vaccine
Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, single dose
Other Names:
  • TENIVAC™
Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, Single dose
Other Names:
  • DECAVAC®
Active Comparator: United States Td Vaccine Group
Participants received US manufactured Td vaccine
Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, single dose
Other Names:
  • TENIVAC™
Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, Single dose
Other Names:
  • DECAVAC®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.
Time Frame: 28 Days post-vaccination
Seroprotection and booster responses for both tetanus and diphtheria were considered to be an antibody level of ≥ 0.10 IU/mL 28 days post-vaccination with either the Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine or the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in participants ≥ 60 years of age.
28 Days post-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 28 Days post-vaccination
28 Days post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.
Time Frame: 0-14 days post-vaccination
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Chills, Diarrhea, Fever (temperature), Headache, Malaise, Muscle weakness, Nausea, Pain in joints, Rash, and Vomiting.
0-14 days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tetanus

Clinical Trials on Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe