Evaluation of Boostrix™10 Years After Previous Booster Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01147900
First received: May 20, 2010
Last updated: October 24, 2013
Last verified: August 2013
Results First Received: April 25, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Acellular Pertussis
Tetanus
Diphtheria
Interventions: Biological: Boostrix™
Biological: Boostrix™-US formulation

  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
Subjects consisted of those previously vaccinated & boosted in GSK263855/029 study and contacted for participation in this booster (BST) study. Duration of this study was about 19 months, from Year 8.5 (8.5 years post BST in GSK263855/029 study) to one month post BST in this study (Year 10 [10 years post BST in GSK263855/029 study] + one month).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At Year 8.5, a total of 180 subjects (out of the 478 planned) were enrolled: 54, 60 and 66 subjects in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively. At Year 10, a total of 177 subjects (out of the 180 planned) were enrolled: 55, 60 and 62 in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively.

Reporting Groups
  Description
Boostrix-US Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Boostrix-INV Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Boostrix-REF Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Participant Flow for 2 periods

Period 1:   At Year 8.5
    Boostrix-US Group     Boostrix-INV Group     Boostrix-REF Group  
STARTED     54     60     66  
COMPLETED     54     60     66  
NOT COMPLETED     0     0     0  

Period 2:   At Year 10
    Boostrix-US Group     Boostrix-INV Group     Boostrix-REF Group  
STARTED     55     60     62  
COMPLETED     55     59     62  
NOT COMPLETED     0     1     0  
Lost to Follow-up                 0                 1                 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
Boostrix-US Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Boostrix-INV Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Boostrix-REF Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
    Boostrix-US Group     Boostrix-INV Group     Boostrix-REF Group     Total  
Number of Participants  
[units: participants]
  54     60     66     180  
Age [1]
[units: Years]
Mean ± Standard Deviation
  22.4  ± 1.46     22.3  ± 1.20     22.3  ± 1.17     22.3  ± 1.28  
Age [2]
[units: Years]
Mean ± Standard Deviation
  23.5  ± 1.44     23.4  ± 1.21     23.3  ± 1.17     23.4  ± 1.27  
Gender [1]
[units: subjects]
       
Female     29     33     39     101  
Male     25     27     27     79  
Gender [2]
[units: subjects]
       
Female     29     31     36     96  
Male     26     29     26     81  
[1] The baseline measure data correspond to Year 8.5.
[2] The baseline measure data correspond to Year 10.



  Outcome Measures
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1.  Primary:   Number of Seroprotected Subjects Against Diphtheria and Tetanus   [ Time Frame: At Year 8.5 ]

2.  Primary:   Concentrations for Anti-D and Anti-T Antibodies.   [ Time Frame: At Year 8.5 ]

3.  Primary:   Number of Seroprotected Subjects Against Diphtheria and Tetanus.   [ Time Frame: At Year 10 ]

4.  Primary:   Concentrations for Anti-D and Anti-T Antibodies.   [ Time Frame: At Year 10 ]

5.  Primary:   Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.   [ Time Frame: At Year 8.5 ]

6.  Primary:   Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.   [ Time Frame: At Year 8.5 ]

7.  Primary:   Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.   [ Time Frame: At Year 10 ]

8.  Primary:   Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.   [ Time Frame: At Year 10 ]

9.  Primary:   Number of Seroprotected Subjects Against Diphtheria and Tetanus   [ Time Frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) ]

10.  Primary:   Concentrations for Anti-D and Anti-T Antibodies.   [ Time Frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) ]

11.  Primary:   Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.   [ Time Frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) ]

12.  Primary:   Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.   [ Time Frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) ]

13.  Primary:   Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.   [ Time Frame: At 1 month post Year 10 booster vaccination ]

14.  Secondary:   Number of Subjects With Any Solicited Local Symptoms.   [ Time Frame: During the 4-day (Days 0-3) follow-up period after booster vaccination ]

15.  Secondary:   Number of Subjects With Any Solicited General Symptoms.   [ Time Frame: During the 4-day (Days 0-3) follow-up period after booster vaccination ]

16.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs).   [ Time Frame: During the 31-day (Days 0-30) follow-up period after booster vaccination ]

17.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs).   [ Time Frame: At Year 8.5 ]

18.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs).   [ Time Frame: From Year 8.5 up to study end (one month post Year 10 booster 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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01147900     History of Changes
Other Study ID Numbers: 113055
Study First Received: May 20, 2010
Results First Received: April 25, 2013
Last Updated: October 24, 2013
Health Authority: Belgium: Direction Générale de la Protection de la Santé Publique Médicaments