Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide 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
  Hide 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  
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
  Show All 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. ]

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 ]

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 ]
  Hide Outcome Measure 8

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 ]

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


  Serious Adverse Events
  Hide Serious Adverse Events

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


  Limitations and Caveats
  Hide 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.


  More Information