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Regulatory Post-Marketing Surveillance Study for TETRAXIM™

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01437423
First received: September 19, 2011
Last updated: November 6, 2016
Last verified: November 2016
Results First Received: November 6, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Intervention: Biological: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio

  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 for a 6 year surveillance period (31 August 2009 to 30 August 2015) at 8 clinic centers in Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 662 participants whose case report forms were retrieved, 647 participants were included in the safety analysis.

Reporting Groups
  Description
TETRAXIM™ Vaccination and Booster Group Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.

Participant Flow:   Overall Study
    TETRAXIM™ Vaccination and Booster Group
STARTED   662 
COMPLETED   647 
NOT COMPLETED   15 
Lost to Follow-up                12 
Off label usage                3 



  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
TETRAXIM™ Vaccination and Booster Group Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.

Baseline Measures
   TETRAXIM™ Vaccination and Booster Group 
Overall Participants Analyzed 
[Units: Participants]
 647 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      647 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Months]
Mean (Standard Deviation)
 8.16  (13.43) 
Gender 
[Units: Participants]
Count of Participants
 
Female      327  50.5% 
Male      320  49.5% 
Region of Enrollment 
[Units: Participants]
 
Korea, Republic of   647 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.   [ Time Frame: Up to 30 days post-primary and booster vaccination ]

2.  Other Pre-specified:   Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.   [ Time Frame: Up to 30 days post-primary and booster vaccination ]

3.  Other Pre-specified:   Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.   [ Time Frame: Up to 30 days post-primary and booster of TETRAXIM™ vaccination ]

4.  Other Pre-specified:   Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.   [ Time Frame: Up to 30 days post-primary and booster of 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: NCT01437423     History of Changes
Other Study ID Numbers: E2I59
U1111-1114-7745 ( Other Identifier: WHO )
Study First Received: September 19, 2011
Results First Received: November 6, 2016
Last Updated: November 6, 2016