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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: April 12, 2016
Last verified: April 2016
Results First Received: November 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   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 
Overall Participants Analyzed 
[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
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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


  Limitations and Caveats
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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
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  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.


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



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: April 12, 2016