Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01629589
First received: June 22, 2012
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: August 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Tetanus
Diphtheria
Pertussis
Whooping Cough
Interventions: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)

  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
The study participants were enrolled from 20 June 2012 to 10 September 2012 at 8 centers in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 423 participants that met all of the inclusion and none of the exclusion criteria were randomized, 422 were vaccinated in this study.

Reporting Groups
  Description
Adacel® Vaccine Group Participants received a single dose of Adacel® vaccine
BOOSTRIX® Vaccine Group Participants received a single dose of BOOSTRIX® vaccine

Participant Flow:   Overall Study
    Adacel® Vaccine Group     BOOSTRIX® Vaccine Group  
STARTED     212     211  
COMPLETED     204 [1]   204  
NOT COMPLETED     8     7  
Protocol Violation                 4                 2  
Lost to Follow-up                 2                 1  
Withdrawal by Subject                 2                 3  
Did not receive study vaccine                 0                 1  
[1] A participant received the Boostrix vaccine. Study data reported for the Boostrix vaccine group.



  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
BOOSTRIX® Vaccine Group Participants received a single dose of BOOSTRIX® vaccine
Total Total of all reporting groups

Baseline Measures
    Adacel® Vaccine Group     BOOSTRIX® Vaccine Group     Total  
Number of Participants  
[units: participants]
  212     211     423  
Age  
[units: participants]
     
<=18 years     212     211     423  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  11.6  ± 0.5     11.6  ± 0.5     11.6  ± 0.5  
Gender  
[units: participants]
     
Female     105     106     211  
Male     107     105     212  
Region of Enrollment  
[units: Participants]
     
United States     212     211     423  



  Outcome Measures
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1.  Primary:   Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine   [ Time Frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination) ]

2.  Secondary:   Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine   [ Time Frame: Day 0 (pre-vaccination) to Day 28 post-vaccination ]

3.  Secondary:   Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine   [ Time Frame: Day 28 post-vaccination ]

4.  Secondary:   Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine   [ Time Frame: Day 0 (pre-vaccination) to Day 28 post-vaccination ]

5.  Secondary:   Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine   [ Time Frame: Day 28 post-vaccination ]

6.  Secondary:   Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine   [ Time Frame: Up to 15 minutes 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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01629589     History of Changes
Other Study ID Numbers: Td551, U1111-1127-6774
Study First Received: June 22, 2012
Results First Received: August 16, 2013
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration