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A Study to Assess the Safety of Adacel® Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01040052
First received: December 21, 2009
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: March 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Diphtheria
Tetanus
Pertussis
Intervention: Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)

  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 06 to 13 December 2009 in 1 medical center in Vietnam.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 30 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and evaluated.

Reporting Groups
  Description
ADACEL® Vaccine Group All participants received a single dose of ADACEL® vaccine on Day 0.

Participant Flow:   Overall Study
    ADACEL® Vaccine Group  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     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 All participants received a single dose of ADACEL® vaccine on Day 0.

Baseline Measures
    ADACEL® Vaccine Group  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     0  
Age  
[units: Years]
Mean ± Standard Deviation
  35.1  ± 5.82  
Gender  
[units: participants]
 
Female     12  
Male     18  
Region of Enrollment  
[units: participants]
 
Vietnam     30  



  Outcome Measures

1.  Primary:   Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine   [ Time Frame: Days 0-7 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
No text entered.


  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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01040052     History of Changes
Other Study ID Numbers: TD532, U1111-1111-6093
Study First Received: December 21, 2009
Results First Received: March 1, 2011
Last Updated: January 10, 2014
Health Authority: Vietnam: Ministry of Health