Trial record 1 of 1 for:
P3T10
Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
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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: NCT00802867 |
Recruitment Status :
Completed
First Posted : December 5, 2008
Results First Posted : January 12, 2010
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 |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis Polio Haemophilus Infection |
Intervention |
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) |
Enrollment | 989 |
Participant Flow
Recruitment Details | Participants were enrolled from 05 February through 30 November 2004 at 19 US sites. |
Pre-assignment Details | A total of 989 participants were enrolled and vaccinated with DAPTACEL as the fifth dose after receiving 4 doses of Pentacel vaccine in previous studies. |
Arm/Group Title | DAPTACEL® Vaccine Group |
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Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03. |
Period Title: Overall Study | |
Started | 989 |
Completed | 976 |
Not Completed | 13 |
Reason Not Completed | |
Lost to Follow-up | 6 |
Protocol Violation | 6 |
Withdrawal by Subject | 1 |
Baseline Characteristics
Arm/Group Title | DAPTACEL® Vaccine Group | |
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Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03. | |
Overall Number of Baseline Participants | 989 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 989 participants | |
<=18 years |
989 100.0%
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Between 18 and 65 years |
0 0.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 989 participants | |
4.2 (0.15) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 989 participants | |
Female |
514 52.0%
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Male |
475 48.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 989 participants |
989 |
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: | NCT00802867 |
Other Study ID Numbers: |
P3T10 |
First Submitted: | December 4, 2008 |
First Posted: | December 5, 2008 |
Results First Submitted: | September 24, 2009 |
Results First Posted: | January 12, 2010 |
Last Update Posted: | April 14, 2016 |