Persistence Study of GSK Bio's Tdap Vaccine 1, 3, 5 and 10 Years After Administration as a Single Dose in 106316 Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00489970
First received: June 21, 2007
Last updated: May 1, 2014
Last verified: April 2014
Results First Received: July 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Acellular Pertussis
Tetanus
Diphtheria
Interventions: Procedure: Taking of blood samples
Biological: Boostrix
Biological: Adacel

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who received a single dose of Boostrix or Adacel vaccines, in the primary study (NCT00346073) were included in this study.

Reporting Groups
  Description
Boostrix Group Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
Adacel Group Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.

Participant Flow for 3 periods

Period 1:   Persistence Year 1
    Boostrix Group     Adacel Group  
STARTED     1069     523  
COMPLETED     1069     523  
NOT COMPLETED     0     0  

Period 2:   Persistence Year 3
    Boostrix Group     Adacel Group  
STARTED     1019 [1]   486 [1]
COMPLETED     1019     486  
NOT COMPLETED     0     0  
[1] Number of subjects who returned at Year 3

Period 3:   Persistence Year 5
    Boostrix Group     Adacel Group  
STARTED     856 [1]   401 [1]
COMPLETED     856     401  
NOT COMPLETED     0     0  
[1] Number of subjects who returned at Year 5



  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
Boostrix Group Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
Adacel Group Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
Total Total of all reporting groups

Baseline Measures
    Boostrix Group     Adacel Group     Total  
Number of Participants  
[units: participants]
  1069     523     1592  
Age  
[units: years]
Mean ± Standard Deviation
  41.7  ± 13.39     42.5  ± 13.27     42.0  ± 13.35  
Gender  
[units: participants]
     
Female     680     357     1037  
Male     389     166     555  



  Outcome Measures
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1.  Primary:   Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 1, 3 and 5 years following vaccination ]

2.  Primary:   Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 1, 3 and 5 years following vaccination ]

3.  Secondary:   Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 1, 3 and 5 years following vaccination ]

4.  Secondary:   Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 1, 3 and 5 years following vaccination ]

5.  Secondary:   Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 1, 3 and 5 years following vaccination ]

6.  Secondary:   Anti-D Antibody Concentration   [ Time Frame: 1, 3 and 5 years following vaccination ]

7.  Secondary:   Anti-T Antibody Concentration   [ Time Frame: 1, 3 and 5 years following vaccination ]

8.  Secondary:   Anti-PT Antibody Concentration   [ Time Frame: 1, 3 and 5 years following vaccination ]

9.  Secondary:   Anti-FHA Antibody Concentration   [ Time Frame: 1, 3 and 5 years following vaccination ]

10.  Secondary:   Anti-PRN Antibody Concentration   [ Time Frame: 1, 3 and 5 years following vaccination ]

11.  Primary:   Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

12.  Primary:   Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

13.  Secondary:   Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

14.  Secondary:   Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

15.  Secondary:   Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

16.  Secondary:   Anti-D Antibody Concentration   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

17.  Secondary:   Anti-T Antibody Concentration   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

18.  Secondary:   Anti-PT Antibody Concentration   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

19.  Secondary:   Anti-FHA Antibody Concentration   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

20.  Secondary:   Anti-PRN Antibody Concentration   [ Time Frame: 10 years following vaccination ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00489970     History of Changes
Other Study ID Numbers: 110080, 110082, 110084, 110086
Study First Received: June 21, 2007
Results First Received: July 15, 2010
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration