Trial record 1 of 1 for:
M5A08
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
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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: NCT00772369 |
Recruitment Status :
Completed
First Posted : October 15, 2008
Results First Posted : April 2, 2010
Last Update Posted : February 14, 2014
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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 | Observational |
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Study Design | Observational Model: Cohort; Time Perspective: Retrospective |
Conditions |
Diphtheria Pertussis Haemophilus Infection Tetanus Polio |
Enrollment | 3214 |
Participant Flow
Recruitment Details | Telephone contact for this study was from 20 September 2003 to 30 April 2004. |
Pre-assignment Details | A total of 3214 participants that met the inclusion and exclusion criteria were enrolled in this survey. One participant did not return a record release form and twenty-nine (29) others were also excluded from the Primary Analysis Population because their safety data could not be confirmed. |
Arm/Group Title | Study Group |
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Received 4th dose of the Pentacel® series before 2nd birthday |
Period Title: Overall Study | |
Started | 3214 |
Completed | 3213 |
Not Completed | 1 |
Reason Not Completed | |
Did not return record release form | 1 |
Baseline Characteristics
Arm/Group Title | Study Group | |
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Received 4th dose of the Pentacel® series before 2nd birthday | |
Overall Number of Baseline Participants | 3214 | |
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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 | 3214 participants | |
<=18 years |
3214 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: Months |
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Number Analyzed | 3214 participants | |
19.5 (1.45) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3214 participants | |
Female |
1538 47.9%
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Male |
1676 52.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Canada | Number Analyzed | 3214 participants |
3214 |
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: | NCT00772369 |
Other Study ID Numbers: |
M5A08 |
First Submitted: | October 13, 2008 |
First Posted: | October 15, 2008 |
Results First Submitted: | March 15, 2010 |
Results First Posted: | April 2, 2010 |
Last Update Posted: | February 14, 2014 |