Trial record 1 of 1 for:
GRC57
Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults
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ClinicalTrials.gov Identifier: NCT02563093 |
Recruitment Status :
Completed
First Posted : September 29, 2015
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
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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, 2015-2016 formulation, No Preservative Biological: Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation Biological: Fluzone High-Dose vaccine, 2015-2016 formulation |
Enrollment | 208 |
Participant Flow
Recruitment Details | Study participants were enrolled from 28 September 2015 to 03 November 2015 at 4 clinic centers in the United States. |
Pre-assignment Details | A total of 208 participants who met all of the inclusion criteria and no exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Fluzone Quadrivalent Vaccine (≥ 65 Years) | Fluzone High-Dose Vaccine (≥ 65 Years) |
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Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine | Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine |
Period Title: Overall Study | ||||
Started | 52 | 52 | 53 | 51 |
Completed | 52 | 52 | 53 | 51 |
Not Completed | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Fluzone Quadrivalent Intradermal Vaccine | Fluzone Quadrivalent Vaccine (≥ 65 Years) | Fluzone High-Dose Vaccine | Total | |
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Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine | Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine | Total of all reporting groups | |
Overall Number of Baseline Participants | 52 | 52 | 53 | 51 | 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 | 52 participants | 52 participants | 53 participants | 51 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 |
52 100.0%
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52 100.0%
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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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53 100.0%
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51 100.0%
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104 50.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 52 participants | 52 participants | 53 participants | 51 participants | 208 participants | |
46.4 (13.5) | 43.4 (14.7) | 72.8 (5.2) | 74.2 (6.2) | 59.2 (17.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 52 participants | 52 participants | 53 participants | 51 participants | 208 participants | |
Female |
37 71.2%
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39 75.0%
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28 52.8%
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26 51.0%
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130 62.5%
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Male |
15 28.8%
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13 25.0%
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25 47.2%
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25 49.0%
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78 37.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 52 participants | 52 participants | 53 participants | 51 participants | 208 participants |
52 | 52 | 53 | 51 | 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: | NCT02563093 |
Other Study ID Numbers: |
GRC57 U1111-1161-2491 ( Other Identifier: WHO ) |
First Submitted: | September 28, 2015 |
First Posted: | September 29, 2015 |
Results First Submitted: | August 26, 2016 |
Results First Posted: | December 12, 2016 |
Last Update Posted: | December 12, 2016 |