Trial record 1 of 1 for:
IPV46
Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
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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: NCT02005536 |
Recruitment Status :
Completed
First Posted : December 9, 2013
Results First Posted : March 30, 2015
Last Update Posted : March 30, 2015
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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: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Poliomyelitis Polio |
Intervention |
Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine |
Enrollment | 60 |
Participant Flow
Recruitment Details | Participants were enrolled from 02 December 2013 to 28 April 2014 at 4 Clinical trial centers in Japan. |
Pre-assignment Details | A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. A subject with an exclusion criteria was later discovered and was excluded in the per-protocol analysis set. |
Arm/Group Title | IMOVAX POLIO® Vaccine Group |
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Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0. |
Period Title: Overall Study | |
Started | 60 |
Completed | 60 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | IMOVAX POLIO® Vaccine Group | |
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Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0. | |
Overall Number of Baseline Participants | 60 | |
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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 | 60 participants | |
<=18 years |
60 100.0%
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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 | 60 participants | |
4.0 (0.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 60 participants | |
Female |
25 41.7%
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Male |
35 58.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Japan | Number Analyzed | 60 participants |
60 |
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: | NCT02005536 |
Other Study ID Numbers: |
IPV46 (EFC13614) U1111-1143-8561 ( Other Identifier: WHO ) |
First Submitted: | December 3, 2013 |
First Posted: | December 9, 2013 |
Results First Submitted: | March 17, 2015 |
Results First Posted: | March 30, 2015 |
Last Update Posted: | March 30, 2015 |