Trial record 1 of 1 for:
MPS01
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine 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: NCT01430611 |
Recruitment Status :
Completed
First Posted : September 8, 2011
Results First Posted : May 8, 2014
Last Update Posted : May 8, 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: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Meningococcal Disease Meningitis |
Intervention |
Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine |
Enrollment | 666 |
Participant Flow
Recruitment Details | The study participants were enrolled from 23 August 2011 to 12 October 2011 at a single center in China. |
Pre-assignment Details | A total of 665 of the 666 participants who met all of the inclusion and none of the exclusion criteria that were randomized were vaccinated in this study. |
Arm/Group Title | Meningo A+C® (Group 1) | Meng Ling Kang® (Group 2) |
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Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine | Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine |
Period Title: Overall Study | ||
Started | 332 | 333 |
Completed | 315 | 318 |
Not Completed | 17 | 15 |
Reason Not Completed | ||
Adverse Event | 0 | 1 |
Protocol Violation | 1 | 0 |
Lost to Follow-up | 1 | 0 |
Withdrawal by Subject | 15 | 14 |
Baseline Characteristics
Arm/Group Title | Meningo A+C® (Group 1) | Meng Ling Kang® (Group 2) | Total | |
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Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine | Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine | Total of all reporting groups | |
Overall Number of Baseline Participants | 332 | 333 | 665 | |
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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 | 332 participants | 333 participants | 665 participants | |
<=18 years |
332 100.0%
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333 100.0%
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665 100.0%
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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 (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 332 participants | 333 participants | 665 participants | |
3.2 (1.1) | 3.1 (1.0) | 3.2 (1.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 332 participants | 333 participants | 665 participants | |
Female |
144 43.4%
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133 39.9%
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277 41.7%
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Male |
188 56.6%
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200 60.1%
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388 58.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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China | Number Analyzed | 332 participants | 333 participants | 665 participants |
332 | 333 | 665 |
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: | NCT01430611 |
Other Study ID Numbers: |
MPS01 U1111-1120-1190 ( Other Identifier: WHO ) |
First Submitted: | September 6, 2011 |
First Posted: | September 8, 2011 |
Results First Submitted: | February 28, 2014 |
Results First Posted: | May 8, 2014 |
Last Update Posted: | May 8, 2014 |