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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601835
• Other study ID #: TDC01
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2008
• Last updated: April 12, 2016
• Start date: May 2004
• Est. completion date: July 2005

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3651
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Tetanus

Intervention

Biological:
• Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, single dose
• Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
0.5 mL, Intramuscular, Single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.	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	No
Primary	Percentage of Participants = 60 Years of Age With Antibody Levels = 0.10 IU/mL to Tetanus and Diphtheria.	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	No
Secondary	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.		28 Days post-vaccination	No

External Links

•   Link
•   http://www.sanofipasteur.com