Trial record 1 of 1 for:
GRC71
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations
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ClinicalTrials.gov Identifier: NCT02908269 |
Recruitment Status :
Completed
First Posted : September 20, 2016
Results First Posted : January 8, 2018
Last Update Posted : March 29, 2022
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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 |
Interventions |
Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative Biological: Fluzone High-Dose, vaccine, 2016-2017 formulation |
Enrollment | 180 |
Participant Flow
Recruitment Details | Study participants were enrolled in 2 centers in the United States from 15 September 2016 to 28 September 2016. |
Pre-assignment Details | A total of 180 participants (60 for each group) were enrolled and vaccinated in the study. |
Arm/Group Title | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years |
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Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
Period Title: Overall Study | |||
Started | 60 | 60 | 60 |
Completed | 60 | 60 | 60 |
Not Completed | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years | Total | |
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Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. | Total of all reporting groups | |
Overall Number of Baseline Participants | 60 | 60 | 60 | 180 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 60 participants | 60 participants | 60 participants | 180 participants | |
6.03 (1.61) | 42.2 (12.9) | 72.6 (6.19) | 40.3 (28.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 60 participants | 60 participants | 60 participants | 180 participants | |
Female | 26 | 42 | 45 | 113 | |
Male | 34 | 18 | 15 | 67 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 60 participants | 60 participants | 60 participants | 180 participants |
60 | 60 | 60 | 180 |
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: | NCT02908269 |
Other Study ID Numbers: |
GRC71 U1111-1174-4738 ( Other Identifier: WHO ) |
First Submitted: | September 16, 2016 |
First Posted: | September 20, 2016 |
Results First Submitted: | December 8, 2017 |
Results First Posted: | January 8, 2018 |
Last Update Posted: | March 29, 2022 |