Trial record 1 of 1 for:
GRC51
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine
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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: NCT01946425 |
Recruitment Status :
Completed
First Posted : September 19, 2013
Results First Posted : September 25, 2014
Last Update Posted : September 25, 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 |
Condition |
Influenza |
Intervention |
Biological: Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative |
Enrollment | 60 |
Participant Flow
Recruitment Details | The study participants were enrolled from 16 September 2013 to 10 October 2013 at 2 clinic centers in the United States. |
Pre-assignment Details | A total of 60 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study. |
Arm/Group Title | Age 6 Months to <36 Months Group | Age 3 Years to <9 Years Group |
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Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation) | Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation) |
Period Title: Overall Study | ||
Started | 30 | 30 |
Completed | 28 | 30 |
Not Completed | 2 | 0 |
Reason Not Completed | ||
Protocol Violation | 1 | 0 |
Withdrawal by Subject | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Age 6 to <36 Months Group | Age 3 to <9 Years Group | Total | |
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Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation) | Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation) | Total of all reporting groups | |
Overall Number of Baseline Participants | 30 | 30 | 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 | 30 participants | 30 participants | 60 participants | |
<=18 years |
30 100.0%
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30 100.0%
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60 100.0%
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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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Age Continuous | Number Analyzed | 30 participants | 30 participants | 60 participants |
1.9 (0.6) | 5.4 (1.8) | 3.7 (2.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 30 participants | 60 participants | |
Female |
16 53.3%
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19 63.3%
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35 58.3%
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Male |
14 46.7%
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11 36.7%
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25 41.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 30 participants | 30 participants | 60 participants |
30 | 30 | 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: | NCT01946425 |
Other Study ID Numbers: |
GRC51 U1111-1120-1262 ( Other Identifier: WHO ) |
First Submitted: | September 16, 2013 |
First Posted: | September 19, 2013 |
Results First Submitted: | September 17, 2014 |
Results First Posted: | September 25, 2014 |
Last Update Posted: | September 25, 2014 |