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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 : May 25, 2018
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      478  53.9%      237  53.3%      715  53.7% 
Male      409  46.1%      208  46.7%      617  46.3% 


  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) ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Measure Description Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)
Time Frame Before (PRE) and one month after vaccination (POST)  

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   865   439 
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration 
[Units: EL.U/mL]
Geometric Mean (95% Confidence Interval)
   
Anti-PT (PRE) (N=859;433)   6.6 
 (6.1 to 7.1) 
 6.5 
 (5.8 to 7.2) 
Anti-PT (POST) (N=852;431)   49.1 
 (44.9 to 53.7) 
 6.4 
 (5.8 to 7.1) 
Anti-FHA (PRE) (N=848;430)   50.2 
 (46.2 to 54.5) 
 44.3 
 (39.5 to 49.5) 
Anti-FHA (POST) (N=835;428)   689.0 
 (638.8 to 743.1) 
 44.4 
 (39.7 to 49.7) 
Anti-PRN (PRE) (N=864;439)   8.1 
 (7.4 to 8.8) 
 7.8 
 (6.9 to 8.8) 
Anti-PRN (POST) (N=865;439)   104.2 
 (91.3 to 118.9) 
 7.7 
 (6.8 to 8.7) 

No statistical analysis provided for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration



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

Measure Type Secondary
Measure Title Anti-T and Anti-D Antibody Concentrations
Measure Description Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
Time Frame Before (PRE) and one month after vaccination (POST)  

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   864   439 
Anti-T and Anti-D Antibody Concentrations 
[Units: IU/mL]
Geometric Mean (95% Confidence Interval)
   
Anti-D (PRE) (N=844;430)   0.2 
 (0.2 to 0.2) 
 0.2 
 (0.1 to 0.2) 
Anti-D (POST) (N=859;432)   0.9 
 (0.8 to 1.0) 
 0.8 
 (0.7 to 1.0) 
Anti-T (PRE) (N=864;439)   0.6 
 (0.6 to 0.7) 
 0.6 
 (0.5 to 0.7) 
Anti-T (POST) (N=864;439)   4.0 
 (3.6 to 4.3) 
 7.1 
 (6.1 to 8.1) 

No statistical analysis provided for Anti-T and Anti-D Antibody Concentrations



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 ]

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 vaccination up to Day 182 ]


  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
No text entered.


  More Information