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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00835237
First received: February 2, 2009
Last updated: October 6, 2016
Last verified: October 2016
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: Tetanus
Acellular Pertussis
Diphtheria
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 
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
  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 ]
  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  
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 
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 ]

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


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

Responsible Party: GlaxoSmithKline
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: October 6, 2016
Health Authority: United States: Food and Drug Administration