Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
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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. |
ClinicalTrials.gov Identifier: NCT00835237 |
Recruitment Status :
Completed
First Posted : February 3, 2009
Results First Posted : August 5, 2010
Last Update Posted : January 3, 2020
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Tetanus Acellular Pertussis Diphtheria Diphtheria-Tetanus-acellular Pertussis Vaccines |
Interventions |
Biological: Boostrix® Biological: Decavac™ |
Enrollment | 1332 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Boostrix Group | Decavac Group |
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Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) | Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine) |
Period Title: Overall Study | ||
Started | 887 | 445 |
Completed | 881 | 445 |
Not Completed | 6 | 0 |
Reason Not Completed | ||
Lost to Follow-up | 4 | 0 |
Withdrawal by Subject | 2 | 0 |
Baseline Characteristics
Arm/Group Title | Boostrix Group | Decavac Group | Total | |
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Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) | Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine) | Total of all reporting groups | |
Overall Number of Baseline Participants | 887 | 445 | 1332 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 887 participants | 445 participants | 1332 participants | |
71.6 (5.35) | 71.9 (5.62) | 71.7 (5.44) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 887 participants | 445 participants | 1332 participants | |
Female |
478 53.9%
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237 53.3%
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715 53.7%
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Male |
409 46.1%
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208 46.7%
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617 46.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00835237 |
Other Study ID Numbers: |
111413 |
First Submitted: | February 2, 2009 |
First Posted: | February 3, 2009 |
Results First Submitted: | July 8, 2010 |
Results First Posted: | August 5, 2010 |
Last Update Posted: | January 3, 2020 |