Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00835237
First received: February 2, 2009
Last updated: January 5, 2012
Last verified: February 2011
Results First Received: July 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Diphtheria
Pertussis
Diphtheria-Tetanus-acellular Pertussis Vaccines
Tetanus
Interventions: Biological: Boostrix®
Biological: Decavac™

  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
No text entered.

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Participant Flow:   Overall Study
    Boostrix Group     Decavac Group  
STARTED     887     445  
COMPLETED     881     445  
NOT COMPLETED     6     0  
Lost to Follow-up                 4                 0  
Withdrawal by Subject                 2                 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 Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
Total Total of all reporting groups

Baseline Measures
    Boostrix Group     Decavac Group     Total  
Number of Participants  
[units: participants]
  887     445     1332  
Age  
[units: years]
Mean ± Standard Deviation
  71.6  ± 5.35     71.9  ± 5.62     71.7  ± 5.44  
Gender  
[units: participants]
     
Female     478     237     715  
Male     409     208     617  



  Outcome Measures
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1.  Primary:   Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value   [ Time Frame: One month after vaccination. ]

Measure Type Primary
Measure Title Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Measure Description

Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T).

Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL)

Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL

Time Frame One month after vaccination.  
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.
Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  864     439  
Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value  
[units: subjects]
   
Anti-D (≥ 0.1 IU/mL) (N= 859;432)     729     374  
Anti-T (≥ 0.1 IU/mL) (N= 864;439)     836     428  
Anti-T (≥ 1.0 IU/mL) (N= 864;439)     767     395  

No statistical analysis provided for Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value



2.  Primary:   Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration   [ Time Frame: Before (PRE) and one month after vaccination (POST) ]

Measure Type Primary
Measure Title Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Measure Description Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)
Time Frame Before (PRE) and one month after vaccination (POST)  
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.
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  865     439  
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration  
[units: EL.U/mL]
Geometric Mean ( 95% Confidence Interval )
   
Anti-PT (PRE) (N=859;433)     6.6  
  ( 6.1 to 7.1 )  
  6.5  
  ( 5.8 to 7.2 )  
Anti-PT (POST) (N=852;431)     49.1  
  ( 44.9 to 53.7 )  
  6.4  
  ( 5.8 to 7.1 )  
Anti-FHA (PRE) (N=848;430)     50.2  
  ( 46.2 to 54.5 )  
  44.3  
  ( 39.5 to 49.5 )  
Anti-FHA (POST) (N=835;428)     689.0  
  ( 638.8 to 743.1 )  
  44.4  
  ( 39.7 to 49.7 )  
Anti-PRN (PRE) (N=864;439)     8.1  
  ( 7.4 to 8.8 )  
  7.8  
  ( 6.9 to 8.8 )  
Anti-PRN (POST) (N=865;439)     104.2  
  ( 91.3 to 118.9 )  
  7.7  
  ( 6.8 to 8.7 )  

No statistical analysis provided for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration



3.  Secondary:   Anti-T and Anti-D Antibody Concentrations   [ Time Frame: Before (PRE) and one month after vaccination (POST) ]

Measure Type Secondary
Measure Title Anti-T and Anti-D Antibody Concentrations
Measure Description Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
Time Frame Before (PRE) and one month after vaccination (POST)  
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.
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  864     439  
Anti-T and Anti-D Antibody Concentrations  
[units: IU/mL]
Geometric Mean ( 95% Confidence Interval )
   
Anti-D (PRE) (N=844;430)     0.2  
  ( 0.2 to 0.2 )  
  0.2  
  ( 0.1 to 0.2 )  
Anti-D (POST) (N=859;432)     0.9  
  ( 0.8 to 1.0 )  
  0.8  
  ( 0.7 to 1.0 )  
Anti-T (PRE) (N=864;439)     0.6  
  ( 0.6 to 0.7 )  
  0.6  
  ( 0.5 to 0.7 )  
Anti-T (POST) (N=864;439)     4.0  
  ( 3.6 to 4.3 )  
  7.1  
  ( 6.1 to 8.1 )  

No statistical analysis provided for Anti-T and Anti-D Antibody Concentrations



4.  Secondary:   Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off   [ Time Frame: One month after vaccination ]

Measure Type Secondary
Measure Title Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off
Measure Description

Booster response defined as :

For initially seronegative subjects (< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination.

For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.

Time Frame One month after vaccination  
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.
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  863     439  
Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off  
[units: subjects]
   
Anti-D (N=842;428)     383     189  
Anti-T (N=863;439)     438     306  

No statistical analysis provided for Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off



5.  Secondary:   Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off   [ Time Frame: One month after vaccination ]

Measure Type Secondary
Measure Title Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Measure Description

Booster response defined as :

For initially seronegative subjects (< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination.

For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.

For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration.

Time Frame One month after vaccination  
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.
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  864     439  
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off  
[units: subjects]
   
Anti-PT (N=846;430)     585     430  
Anti-FHA (N=821;422)     762     7  
Anti-PRN (N=864;439)     638     9  

No statistical analysis provided for Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off



6.  Secondary:   Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.   [ Time Frame: One month after vaccination ]

Measure Type Secondary
Measure Title Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
Measure Description

Vaccine response defined as:

For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination.

For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration.

Time Frame One month after vaccination  
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.
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  864     439  
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.  
[units: subjects]
   
Anti-PT (N=846;430)     699     9  
Anti-FHA (N=821;422)     765     8  
Anti-PRN (N=864;439)     714     11  

No statistical analysis provided for Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.



7.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Solicited Local Symptoms
Measure Description Solicited local symptoms assessed include pain, redness and swelling.
Time Frame Within the 4-day (Day 0-3) post-vaccination period  
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.
Analysis was performed on the Total Vaccinated cohort on subjects with available results

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  882     445  
Number of Subjects Reporting Solicited Local Symptoms  
[units: subjects]
   
Pain     190     123  
Redness     95     56  
Swelling     66     52  

No statistical analysis provided for Number of Subjects Reporting Solicited Local Symptoms



8.  Secondary:   Number of Subjects Reporting Solicited General Symptoms   [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Solicited General Symptoms
Measure Description Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever
Time Frame Within the 4-day (Day 0-3) post-vaccination period  
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.
Analysis was performed on the Total Vaccinated cohort on subjects with available results

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  882     445  
Number of Subjects Reporting Solicited General Symptoms  
[units: subjects]
   
Fatigue     110     66  
Gastrointestinal symptoms     67     41  
Headache     101     52  
Fever     18     11  

No statistical analysis provided for Number of Subjects Reporting Solicited General Symptoms



9.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Unsolicited Adverse Events (AE)
Measure Description An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Within the 31-day (Day 0-30) post-vaccination period  
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.
No text entered.

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  887     445  
Number of Subjects Reporting Unsolicited Adverse Events (AE)  
[units: subjects]
  152     64  

No statistical analysis provided for Number of Subjects Reporting Unsolicited Adverse Events (AE)



10.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: From the vaccintation up to Day 182 ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Serious Adverse Events (SAE)
Measure Description An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time Frame From the vaccintation up to Day 182  
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.
No text entered.

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values
    Boostrix Group     Decavac Group  
Number of Participants Analyzed  
[units: participants]
  887     445  
Number of Subjects Reporting Serious Adverse Events (SAE)  
[units: subjects]
  37     10  

No statistical analysis provided for Number of Subjects Reporting Serious Adverse Events (SAE)




  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Boostrix Group Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Decavac Group Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Other Adverse Events
    Boostrix Group     Decavac Group  
Total, other (not including serious) adverse events      
# participants affected / at risk     190/887     123/445  
General disorders      
Pain    
# participants affected / at risk     190/887 (21.42%)     123/445 (27.64%)  
Redness    
# participants affected / at risk     95/887 (10.71%)     56/445 (12.58%)  
Swelling    
# participants affected / at risk     66/887 (7.44%)     52/445 (11.69%)  
Fatigue    
# participants affected / at risk     110/887 (12.40%)     66/445 (14.83%)  
Gastrointestinal symptoms    
# participants affected / at risk     67/887 (7.55%)     41/445 (9.21%)  
Headache    
# participants affected / at risk     101/887 (11.39%)     52/445 (11.69%)  
Events were collected by systematic assessment



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


Publications:
Weston WM et al. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Boostrix™): results of a randomized clinical trial. Abstract presented at the 45th National Immunization Conference (NIC). Washington, USA, 28-31 March 2011.

Publications automatically indexed to this study:

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00835237     History of Changes
Other Study ID Numbers: 111413
Study First Received: February 2, 2009
Results First Received: July 8, 2010
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration