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Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00258895
First received: November 24, 2005
Last updated: April 28, 2010
Last verified: April 2010
History of Changes
Results First Received: August 18, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Diphtheria
Tetanus
Pertussis
Intervention: Biological: DAPTACEL®: DTaP

  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 30 March 2005 to 02 March 2006 at 22 US sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
DAPTACEL®-Primed Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Pentacel®-Primed Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.

Participant Flow:   Overall Study
    DAPTACEL®-Primed     Pentacel®-Primed  
STARTED     487     162  
COMPLETED     477     159  
NOT COMPLETED     10     3  
Lost to Follow-up                 3                 1  
Protocol Violation                 6                 2  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
DAPTACEL®-Primed Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Pentacel®-Primed Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Total Total of all reporting groups

Baseline Measures
    DAPTACEL®-Primed     Pentacel®-Primed     Total  
Number of Participants  
[units: participants]
 		  487     162     649  
Age  
[units: participants]
 		     
<=18 years     487     162     649  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation 		  4.1  ± 0.14     4.1  ± 0.16     4.1  ± 0.14  
Gender  
[units: participants]
 		     
Female     244     83     327  
Male     243     79     322  
Region of Enrollment  
[units: participants]
 		     
United States     487     162     649  



  Outcome Measures
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1.  Primary:   Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination   [ Time Frame: 0 to 7 days Post-Dose 5 ]
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2.  Primary:   Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination   [ Time Frame: Day 28 to 48 Post-dose 5 ]
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3.  Primary:   Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination   [ Time Frame: Day 28 to 48 Post-Dose 5 ]
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4.  Primary:   Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.   [ Time Frame: Day 0 and between Days 28-48 Post-dose 5 ]
  Show Outcome Measure 4

5.  Primary:   Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination   [ Time Frame: Day 0 and between Days 28-48 post-dose 5 ]
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Measure Type Primary
Measure Title Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination
Measure Description No text entered.
Time Frame Day 0 and between Days 28-48 post-dose 5  
Safety Issue No  

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.
GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.

Reporting Groups
  Description
DAPTACEL®-Primed Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Pentacel®-Primed Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.

Measured Values
    DAPTACEL®-Primed     Pentacel®-Primed  
Number of Participants Analyzed  
[units: participants]
 		  255     81  
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination  
[units: All units]
Geometric Mean ( 95% Confidence Interval ) 		   
Anti-Pertussis (EU/mL) Pre-Dose     7.67  
  ( 6.66 to 8.84 )   		  9.80  
  ( 7.81 to 12.29 )  
Anti-Pertussis (EU/mL) Post-Dose     154.32  
  ( 139.58 to 170.62 )   		  180.77  
  ( 150.33 to 217.38 )  
Anti-Filamentous Haemagglutinin (EU/mL) Pre-Dose     5.03  
  ( 4.25 to 5.96 )   		  7.52  
  ( 5.45 to 10.39 )  
Anti-Filamentous Haemagglutinin (EU/mL) Post-Dose     82.11  
  ( 73.39 to 91.88 )   		  120.03  
  ( 98.10 to 146.86 )  
Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose     24.45  
  ( 21.22 to 28.16 )   		  34.50  
  ( 27.00 to 44.09 )  
Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose     450.56  
  ( 407.40 to 498.30 )   		  649.86  
  ( 551.73 to 765.45 )  
Anti-Pertactin (EU/mL) Pre-dose     15.62  
  ( 13.72 to 17.78 )   		  9.16  
  ( 7.10 to 11.81 )  
Anti-Pertactin (EU/mL) Post-dose     229.59  
  ( 207.45 to 254.08 )   		  148.80  
  ( 120.63 to 183.55 )  
Anti-Diphtheria (IU/mL) Pre-dose     0.11  
  ( 0.09 to 0.12 )   		  0.11  
  ( 0.08 to 0.14 )  
Anti-Diphtheria (IU/mL) Post-dose     19.59  
  ( 17.06 to 22.51 )   		  22.56  
  ( 17.78 to 28.62 )  
Anti-Tetanus (IU/mL) Pre-dose     0.38  
  ( 0.33 to 0.43 )   		  0.27  
  ( 0.21 to 0.34 )  
Anti-Tetanus (IU/mL) Post-dose     6.21  
  ( 5.59 to 6.89 )   		  4.47  
  ( 3.75 to 5.34 )  

No statistical analysis provided for Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination




  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
No text entered.  


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: NCT00258895     History of Changes
Other Study ID Numbers: P3T11
Study First Received: November 24, 2005
Results First Received: August 18, 2009
Last Updated: April 28, 2010
Health Authority: United States: Food and Drug Administration