Trial record 1 of 1 for:
MTA19
Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
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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: NCT00777790 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Results First Posted : March 19, 2009
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 | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Meningitis Meningococcemia |
Intervention |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
Enrollment | 241 |
Participant Flow
Recruitment Details | Subjects were recruited from 20 February 2004 to 08 April 2004 at 9 medical clinics in the US. |
Pre-assignment Details | A total of 241 subjects that met the inclusion criteria were enrolled and vaccinated. |
Arm/Group Title | Menactra® Group | Menomune® Group | Control Group |
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Subjects that received Menactra® vaccine in Study MTA02 | Subjects that received Menomune® vaccine in Study MTA02 | Meningococcal vaccine-naïve subjects |
Period Title: Overall Study | |||
Started | 76 | 77 | 88 |
Completed | 76 | 77 | 88 |
Not Completed | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Menactra® Group | Menomune® Group | Control Group | Total | |
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Subjects that received Menactra® vaccine in Study MTA02 | Subjects that received Menomune® vaccine in Study MTA02 | Meningococcal vaccine-naïve subjects | Total of all reporting groups | |
Overall Number of Baseline Participants | 76 | 77 | 88 | 241 | |
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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 | 76 participants | 77 participants | 88 participants | 241 participants | |
<=18 years |
56 73.7%
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57 74.0%
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68 77.3%
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181 75.1%
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Between 18 and 65 years |
20 26.3%
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20 26.0%
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20 22.7%
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60 24.9%
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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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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 76 participants | 77 participants | 88 participants | 241 participants | |
16.6 (1.91) | 16.8 (1.85) | 15.7 (1.97) | 16.4 (1.97) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 76 participants | 77 participants | 88 participants | 241 participants | |
Female |
30 39.5%
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31 40.3%
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44 50.0%
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105 43.6%
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Male |
46 60.5%
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46 59.7%
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44 50.0%
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136 56.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 76 participants | 77 participants | 88 participants | 241 participants |
76 | 77 | 88 | 241 |
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: | NCT00777790 |
Other Study ID Numbers: |
MTA19 |
First Submitted: | October 21, 2008 |
First Posted: | October 22, 2008 |
Results First Submitted: | December 2, 2008 |
Results First Posted: | March 19, 2009 |
Last Update Posted: | February 14, 2014 |