Trial record 1 of 1 for:
QHD00008
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years
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ClinicalTrials.gov Identifier: NCT03233217 |
Recruitment Status :
Completed
First Posted : July 28, 2017
Results First Posted : December 17, 2019
Last Update Posted : April 4, 2022
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Collaborator:
Sanofi K.K.
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: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Condition |
Influenza |
Interventions |
Biological: QIV-HD by IM Biological: QIV-SD by SC Biological: QIV-HD by SC |
Enrollment | 175 |
Participant Flow
Recruitment Details | Study participants were enrolled from 15 September 2017 to 26 October 2017 at 2 centers in Japan. |
Pre-assignment Details | 10 participants were randomized 1:1 to receive either QIV-HD by intramuscular (IM) route or QIV-HD by subcutaneous (SC) route (Cohort 1). After review of local and systemic AEs for 7 days post-vaccination in Cohort 1, remaining 165 participants were randomized 1:1:1 to receive QIV-HD by IM route, QIV-HD by SC route, or QIV-SD by SC route (Cohort 2) |
Arm/Group Title | Cohort 1: QIV-HD by IM | Cohort 1: QIV-HD by SC | Cohort 2: QIV-HD by IM | Cohort 2: QIV-HD by SC | Cohort 2: QIV-SD by SC |
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Participants were randomized to receive a single 0.7-milliliter (mL) injection of high-dose Quadrivalent influenza vaccine (QIV-HD) by IM route on Day 0. | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. | Participants were randomized to receive a single 0.5 mL injection of standard-dose Quadrivalent influenza vaccine (QIV-SD) by SC route on Day 0. |
Period Title: Overall Study | |||||
Started [1] | 5 | 5 | 55 | 55 | 55 |
Safety Analysis Set (SafAS) | 5 | 5 | 55 | 55 | 55 |
Per-protocol Analysis Set (PPAS) [2] | 5 | 5 | 55 | 55 | 54 |
Completed | 5 | 5 | 55 | 55 | 55 |
Not Completed | 0 | 0 | 0 | 0 | 0 |
[1]
Randomized and vaccinated.
[2]
Cohort 1 = 10 participants, and Cohort 2 = 164 participants
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Baseline Characteristics
Arm/Group Title | Cohort 1: QIV-HD by IM | Cohort 1: QIV-HD by SC | Cohort 2: QIV-HD by IM | Cohort 2: QIV-HD by SC | Cohort 2: QIV-SD by SC | Total | |
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Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. | Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. | Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0. | Total of all reporting groups | |
Overall Number of Baseline Participants | 5 | 5 | 55 | 55 | 55 | 175 | |
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The baseline characteristics was analyzed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 5 participants | 5 participants | 55 participants | 55 participants | 55 participants | 175 participants | |
70.8 (2.0) | 70.8 (2.3) | 70.1 (3.7) | 70.5 (3.6) | 69.9 (3.8) | 70.2 (3.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 5 participants | 5 participants | 55 participants | 55 participants | 55 participants | 175 participants | |
Female |
1 20.0%
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1 20.0%
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27 49.1%
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26 47.3%
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25 45.5%
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80 45.7%
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Male |
4 80.0%
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4 80.0%
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28 50.9%
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29 52.7%
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30 54.5%
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95 54.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 5 participants | 5 participants | 55 participants | 55 participants | 55 participants | 175 participants | |
American Indian or Alaska Native |
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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0 0.0%
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Asian |
5 100.0%
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5 100.0%
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55 100.0%
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55 100.0%
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55 100.0%
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175 100.0%
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Native Hawaiian or Other Pacific Islander |
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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0 0.0%
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Black or African American |
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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0 0.0%
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White |
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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0 0.0%
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More than one race |
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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0 0.0%
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Unknown or Not Reported |
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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0 0.0%
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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.
The 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 |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT03233217 |
Other Study ID Numbers: |
QHD00008 U1111-1183-5525 ( Other Identifier: World Health Organization Universal Trial Number ) DFI15130 ( Other Identifier: Sanofi K.K. ) |
First Submitted: | July 25, 2017 |
First Posted: | July 28, 2017 |
Results First Submitted: | November 28, 2019 |
Results First Posted: | December 17, 2019 |
Last Update Posted: | April 4, 2022 |