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

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ClinicalTrials.gov Identifier: NCT00835237
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : August 5, 2010
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Tetanus
Acellular Pertussis
Diphtheria
Interventions: Biological: Boostrix®
Biological: Decavac™

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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) ]
  Show Outcome Measure 2

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

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Hide Outcome Measure 6

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  

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 
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 ]
  Hide Outcome Measure 7

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  

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 
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 ]
  Show Outcome Measure 8

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

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


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information