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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
History of Changes
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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. ]
  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) ]
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3.  Secondary:   Anti-T and Anti-D Antibody Concentrations   [ Time Frame: Before (PRE) and one month after vaccination (POST) ]
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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 ]
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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 ]
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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 ]
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7.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]
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8.  Secondary:   Number of Subjects Reporting Solicited General Symptoms   [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]
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9.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period ]
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10.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: From the vaccintation up to Day 182 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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