Trial record 1 of 1 for:
GRC55
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults
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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: NCT02258334 |
Recruitment Status :
Completed
First Posted : October 7, 2014
Results First Posted : October 19, 2015
Last Update Posted : October 19, 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: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Condition |
Influenza |
Interventions |
Biological: Fluzone® Quadrivalent vaccine, 2014-2015 formulation Biological: Fluzone I®ntradermal vaccine, 2014-2015 formulation Biological: Fluzone High Dose vaccine, 2014-2015 formulation |
Enrollment | 208 |
Participant Flow
Recruitment Details | Study participants were enrolled from 01 October 2014 to 07 November 2014 at 4 clinical sites in the United States. |
Pre-assignment Details | A total of 208 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in this study. |
Arm/Group Title | Group 1 | Group 2 | Group 3 | Group 4 |
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Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. | Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. | Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. | Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine. |
Period Title: Overall Study | ||||
Started | 50 | 54 | 52 | 52 |
Completed | 49 | 54 | 52 | 52 |
Not Completed | 1 | 0 | 0 | 0 |
Reason Not Completed | ||||
Adverse Event | 1 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Group 1 | Group 2 | Group 3 | Group 4 | Total | |
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Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. | Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. | Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. | Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine. | Total of all reporting groups | |
Overall Number of Baseline Participants | 50 | 54 | 52 | 52 | 208 | |
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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 | 50 participants | 54 participants | 52 participants | 52 participants | 208 participants | |
<=18 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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0 0.0%
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Between 18 and 65 years |
50 100.0%
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54 100.0%
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0 0.0%
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0 0.0%
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104 50.0%
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>=65 years |
0 0.0%
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0 0.0%
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52 100.0%
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52 100.0%
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104 50.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Age Continuous | Number Analyzed | 50 participants | 54 participants | 52 participants | 52 participants | 208 participants |
44.8 (14.9) | 48.0 (12.1) | 73.9 (5.0) | 72.2 (5.4) | 59.8 (16.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 54 participants | 52 participants | 52 participants | 208 participants | |
Female |
31 62.0%
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33 61.1%
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32 61.5%
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31 59.6%
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127 61.1%
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Male |
19 38.0%
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21 38.9%
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20 38.5%
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21 40.4%
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81 38.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 50 participants | 54 participants | 52 participants | 52 participants | 208 participants |
50 | 54 | 52 | 52 | 208 |
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: | NCT02258334 |
Other Study ID Numbers: |
GRC55 U1111-1143-8931 ( Other Identifier: WHO ) |
First Submitted: | October 2, 2014 |
First Posted: | October 7, 2014 |
Results First Submitted: | September 16, 2015 |
Results First Posted: | October 19, 2015 |
Last Update Posted: | October 19, 2015 |