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Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00258908
First received: November 24, 2005
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
Results First Received: April 7, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Diphtheria
Tetanus
Pertussis
Intervention: Biological: Diphteria, tetanus, and Acellular Pertussis 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
Study participants were enrolled from 01 November through 07 December 2005 in 1 medical clinic in Taiwan

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 115 participants that met the inclusion and exclusion criteria were recruited for the study; 112 were vaccinated and included in the final analysis and this report.

Reporting Groups
  Description
ADACEL™ Group Participants received 1 dose of ADACEL™ (TdcP vaccine)

Participant Flow:   Overall Study
    ADACEL™ Group  
STARTED     112 [1]
COMPLETED     112  
NOT COMPLETED     0  
[1] 3 participants were not vaccinated and were not included in the final analysis and in this report.



  Baseline Characteristics
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Reporting Groups
  Description
ADACEL™ Group Participants received 1 dose of ADACEL™ (TdcP vaccine)

Baseline Measures
    ADACEL™ Group  
Number of Participants  
[units: participants]
 		  112  
Age  
[units: participants]
 		 
<=18 years     112  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  6.8  ± 0.30  
Gender  
[units: participants]
 		 
Female     57  
Male     55  
Region of Enrollment  
[units: participants]
 		 
Taiwan     112  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Reponses Pre- and Post-vaccination   [ Time Frame: Day 0 and Day 28 Post-vaccination ]
  Show Outcome Measure 1

2.  Primary:   Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination   [ Time Frame: Day 0 and Day 28 post-vaccination ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination   [ Time Frame: Within 8 days of vaccination ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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.


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
Not Applicable.  


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


No publications provided


Responsible Party: Medical Director, Sanofi Pasteur, Inc.
ClinicalTrials.gov Identifier: NCT00258908     History of Changes
Other Study ID Numbers: TD521
Study First Received: November 24, 2005
Results First Received: April 7, 2009
Last Updated: November 18, 2009
Health Authority: Taiwan: Department of Health