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A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00457249
First received: April 5, 2007
Last updated: September 17, 2012
Last verified: September 2012
Results First Received: September 17, 2012  
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: Pertussis
Tetanus
Diphtheria
Interventions: Biological: ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Biological: DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed

  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 from 28 March to 30 October 2007, at 19 clinic centers in United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1563 participants were enrolled; 1561 were vaccinated with data analyzed and presented in this report.

Reporting Groups
  Description
ADACEL® Vaccine Group Participants received a single dose of ADACEL® vaccine.
DECAVAC® Vaccine Group Participants received a single dose of DECAVAC® vaccine.

Participant Flow:   Overall Study
    ADACEL® Vaccine Group     DECAVAC® Vaccine Group  
STARTED     1170     391  
COMPLETED     1158     389  
NOT COMPLETED     12     2  
Lost to Follow-up                 3                 0  
Protocol Violation                 4                 1  
Withdrawal by Subject                 3                 1  
Serious Adverse Events                 2                 0  



  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
ADACEL® Vaccine Group Participants received a single dose of ADACEL® vaccine.
DECAVAC® Vaccine Group Participants received a single dose of ADACEL® vaccine.
Total Total of all reporting groups

Baseline Measures
    ADACEL® Vaccine Group     DECAVAC® Vaccine Group     Total  
Number of Participants  
[units: participants]
  1170     391     1561  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     1170     391     1561  
Age  
[units: Years]
Mean ± Standard Deviation
  72.2  ± 5.74     72.3  ± 5.63     72.2  ± 5.71  
Gender  
[units: participants]
     
Female     579     198     777  
Male     591     193     784  
Region of Enrollment  
[units: participants]
     
United States     1170     391     1561  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine   [ Time Frame: Day 35 post-vaccination ]

2.  Primary:   Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.   [ Time Frame: Day 35 post-vaccination ]

3.  Primary:   Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.   [ Time Frame: Day 35 post-vaccination ]

4.  Other Pre-specified:   Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.   [ Time Frame: Day 0 up to 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


No publications provided


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00457249     History of Changes
Other Study ID Numbers: TD515
Study First Received: April 5, 2007
Results First Received: September 17, 2012
Last Updated: September 17, 2012
Health Authority: United States: Food and Drug Administration