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. ]

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) ]

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

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 ]

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 ]

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  
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 ]

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

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

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


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 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)

Serious Adverse Events
    Boostrix Group     Decavac Group  
Total, serious adverse events      
# participants affected / at risk     37/887 (4.17%)     10/445 (2.25%)  
Cardiac disorders      
Coronary artery disease *    
# participants affected / at risk     3/887 (0.34%)     0/445 (0.00%)  
Myocardial infarction *    
# participants affected / at risk     2/887 (0.23%)     1/445 (0.22%)  
Acute myocardial infarction *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Angina pectoris *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Atrial tachycardia *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Atrioventricular block complete *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Sick sinus syndrome *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Gastrointestinal disorders      
Gastrointestinal haemorrhage *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Inguinal hernia, obstructive *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
General disorders      
Asthenia *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Chest pain *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Hernia obstructive *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Infections and infestations      
Pneumonia *    
# participants affected / at risk     2/887 (0.23%)     0/445 (0.00%)  
Enterococcal sepsis *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Gastroenteritis *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Klebsiella bacteraemia *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Lobar pneumonia *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Osteomyelitis *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Injury, poisoning and procedural complications      
Hip fracture *    
# participants affected / at risk     2/887 (0.23%)     0/445 (0.00%)  
Femur fracture *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Meniscus lesion *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Road traffic accident *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Vascular graft occlusion *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Metabolism and nutrition disorders      
Hypoglycaemia *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Musculoskeletal and connective tissue disorders      
Arthralgia *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Osteoarthritis *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Spinal column stenosis *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Basal cell carcinoma *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Bone neoplasm malignant *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Breast cancer in situ *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Bronchial carcinoma *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Non-Hodgkin’s lymphoma *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Non-small cell lung cancer metastatic *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Prostate cancer *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Nervous system disorders      
Cerebrovascular accident *    
# participants affected / at risk     2/887 (0.23%)     0/445 (0.00%)  
Transient ischaemic attack *    
# participants affected / at risk     2/887 (0.23%)     0/445 (0.00%)  
Carotid artery occlusion *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Cerebral haemorrhage *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Cervical myelopathy *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Complicated migraine *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Dementia *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Renal and urinary disorders      
Nephrolithiasis *    
# participants affected / at risk     0/887 (0.00%)     1/445 (0.22%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnoea *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Pulmonary embolism *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Vascular disorders      
Aortic stenosis *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
Deep vein thrombosis *    
# participants affected / at risk     1/887 (0.11%)     0/445 (0.00%)  
* Events were collected by non-systematic assessment




  Other Adverse Events


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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