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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00601835
First received: January 15, 2008
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: November 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Diphtheria
Tetanus
Intervention: Biological: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled in the study from 06 May 2004 through 13 December 2004, in 2 medical sites (4 investigators) in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

A total of 3,651 participants that met the inclusion and exclusion criteria were enrolled in the study. One participant declined vaccination.

The immunogenicity subsets consist of all participants ≥ 60 years of age; the safety subsets consist of all participants ≥ 60 years of age and one third of participants 11 to 59 years of age.


Reporting Groups
  Description
Canadian Td Vaccine Group Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
United States Td Vaccine Group Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)

Participant Flow:   Overall Study
    Canadian Td Vaccine Group     United States Td Vaccine Group  
STARTED     2950     700  
COMPLETED     2890     686  
NOT COMPLETED     60     14  
Withdrawal by Subject                 9                 6  
Physician Decision                 1                 0  
Lost to Follow-up                 37                 5  
Adverse Event                 1                 1  
Relocate                 12                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Canadian Td Vaccine Group Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
United States Td Vaccine Group Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
Total Total of all reporting groups

Baseline Measures
    Canadian Td Vaccine Group     United States Td Vaccine Group     Total  
Number of Participants  
[units: participants]
  2950     700     3650  
Age  
[units: participants]
     
<=18 years     1501     0     1501  
Between 18 and 65 years     1000     257     1257  
>=65 years     449     443     892  
Age  
[units: years]
Mean ± Standard Deviation
  33.6  ± 23.49     69.3  ± 7.89     40.5  ± 25.60  
Gender  
[units: participants]
     
Female     1629     403     2032  
Male     1321     297     1618  
Region of Enrollment  
[units: participants]
     
United States     2950     700     3650  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.   [ Time Frame: 28 Days post-vaccination ]

2.  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.   [ Time Frame: 28 Days post-vaccination ]

3.  Other Pre-specified:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


No publications provided


Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00601835     History of Changes
Other Study ID Numbers: TDC01
Study First Received: January 15, 2008
Results First Received: November 16, 2009
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration