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Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610168
First Posted: February 7, 2008
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: February 9, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Acellular Pertussis
Tetanus
Diphtheria
Intervention: Biological: Boostrix TM

  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
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Reporting Groups
  Description
Boostrix I Group Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Boostrix II Group Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    Boostrix I Group   Boostrix II Group
STARTED   75   7 
COMPLETED   73   7 
NOT COMPLETED   2   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 I Group Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Boostrix II Group Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
   Boostrix I Group   Boostrix II Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   7   82 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.1  (0.31)   21.1  (0.38)   21.1  (0.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      66  88.0%      6  85.7%      72  87.8% 
Male      9  12.0%      1  14.3%      10  12.2% 


  Outcome Measures
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1.  Primary:   Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs   [ Time Frame: At Month 0 ]

2.  Primary:   Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs   [ Time Frame: At Month 1 ]

3.  Secondary:   Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations   [ Time Frame: At Month 0 (PRE) and Month 1 (POST) ]

4.  Secondary:   Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)   [ Time Frame: At Month 0 (PRE) and Month 1 (POST) ]

5.  Secondary:   Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations   [ Time Frame: At Month 0 (PRE) and Month 1 (POST) ]

6.  Secondary:   Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)   [ Time Frame: At Month 1 ]

7.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 4-day (Day 0–3) follow-up period after booster vaccination ]

8.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 4-day (Day 0–3) follow-up period after booster vaccination ]

9.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31-day (Day 0–30) follow-up period after booster vaccination ]

10.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group) ]


  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:
He Q et al. Immunity to pertussis 10 years after acellular booster vaccine in adolescence and response to a second dTpa booster in young adults. Abstract presented at the 19th annual european congress of clinical microbiology and infectious diseases, Helsinki, Finland, 16-19 May 2009.
Mertsola J et al. Decennial administration of reduced-antigen dTpa vaccine in young adults - incidence of solicited local symptoms classified by pre-vaccination antibody concentrations. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Mertsola J et al. The immunogenicity and safety of repeated administration of dTpa booster in adolescents and young adults. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009
Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00610168     History of Changes
Other Study ID Numbers: 110806
First Submitted: January 25, 2008
First Posted: February 7, 2008
Results First Submitted: February 9, 2017
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017