NCT00601835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,651

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 18, 2011

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

January 15, 2008

Results QC Date

November 16, 2009

Last Update Submit

April 12, 2016

Conditions

DiphtheriaTetanus

Keywords

DiphtheriaTetanus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.

    0-14 days post-vaccination

Study Arms (2)

Canadian Td Vaccine Group

EXPERIMENTAL

Participants received Canadian manufactured Td vaccine

Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine

United States Td Vaccine Group

ACTIVE COMPARATOR

Participants received US manufactured Td vaccine

Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine

Interventions

Tetanus and Diphtheria Toxoids Adsorbed (Td) VaccineBIOLOGICAL

0.5 mL, Intramuscular, single dose

Also known as: TENIVAC™
Canadian Td Vaccine Group

Eligibility Criteria

Age11 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Oakland, California, 94611, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15241, United States

Location

Related Links

MeSH Terms

Conditions

DiphtheriaTetanus

Interventions

Tetanus ToxoidVaccinesDiphtheria-Tetanus Vaccine

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium Infections

Intervention Hierarchy (Ancestors)

ToxoidsBiological ProductsComplex MixturesBacterial VaccinesDiphtheria ToxoidVaccines, Combined

Results Point of Contact

Title
Medical Director
Organization
Sanofi Pasteur Inc.
RegistryContactUs@sanofipasteur.com

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

May 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

April 14, 2016

Results First Posted

February 18, 2011

Record last verified: 2016-04

Locations

US(2)