Trial record 1 of 1 for:
TRI05
Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
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| ClinicalTrials.gov Identifier: NCT00304265 |
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Recruitment Status :
Completed
First Posted : March 17, 2006
Results First Posted : April 7, 2011
Last Update Posted : April 14, 2016
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
| Conditions |
Pertussis Diphtheria Tetanus Poliomyelitis |
| Intervention |
Biological: COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®) |
| Enrollment | 215 |
Participant Flow
| Recruitment Details | Participants were enrolled from February 2006 to July 2006 at 17 clinical sites in Germany. |
| Pre-assignment Details | A total of 214 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. One over aged participant was also vaccinated and included in the safety analysis. |
| Arm/Group Title | 6th Dose Pertussis Vaccine Group | 5th Dose Pertussis Vaccine Group |
|---|---|---|
 Arm/Group Description |
Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents. | Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents. |
| Period Title: Overall Study | ||
| Started | 117 | 98 |
| Completed | 117 | 98 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 6th Dose Pertussis Vaccine Group | 5th Dose Pertussis Vaccine Group | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents. | Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 117 | 98 | 215 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 117 participants | 98 participants | 215 participants | |
| <=18 years |
117 100.0%
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98 100.0%
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215 100.0%
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| Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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| Number Analyzed | 117 participants | 98 participants | 215 participants | |
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12.3
(11 to 13)
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12.6
(10 to 16)
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12.4
(10 to 16)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 117 participants | 98 participants | 215 participants | |
| Female |
55 47.0%
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37 37.8%
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92 42.8%
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| Male |
62 53.0%
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61 62.2%
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123 57.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| Germany | Number Analyzed | 117 participants | 98 participants | 215 participants |
| 117 | 98 | 215 | ||
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
| Name/Title: | Medical Director |
| Organization: | Sanofi Pasteur Inc. |
| EMail: | RegistryContactUs@sanofipasteur.com |
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT00304265 |
| Other Study ID Numbers: |
TRI05 |
| First Submitted: | March 16, 2006 |
| First Posted: | March 17, 2006 |
| Results First Submitted: | February 10, 2011 |
| Results First Posted: | April 7, 2011 |
| Last Update Posted: | April 14, 2016 |