Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively (GRC00097)

• ClinicalTrials.gov Identifier: NCT04109222
• Recruitment Status: Completed
• First Posted: September 30, 2019
• Results First Posted: December 17, 2020
• Last Update Posted: March 28, 2022
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Influenza
• Interventions: Biological: Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation; Biological: Fluzone High-Dose vaccine, 2019-2020 formulation
• Enrollment: 90

Participant Flow

Recruitment Details	Participants were enrolled from 30 September 2019 to 7 October 2019 at 2 active sites in the United States.
Pre-assignment Details	A total of 90 participants were enrolled and vaccinated in the study.

Arm/Group Title	Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months	Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years	Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Arm/Group Description	Participants aged 6 to <36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP), a second dose was administered at Day 28.	Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.	Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
Period Title: Overall Study
Started [1]	30	30	30
Completed	29	30	30
Not Completed	1	0	0
Reason Not Completed
Adverse Event	1	0	0
[1] Vaccinated participants.

Baseline Characteristics

Arm/Group Title		Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months	Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years	Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years	Total
Arm/Group Description		Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.	Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.	Participants aged >=65 years received 1 dose of 0.5-mL Fluzone high-dose vaccine intramuscular injection at Day 0.	Total of all reporting groups
Overall Number of Baseline Participants		30	30	30	90
Baseline Analysis Population Description		Analysis was performed on all enrolled and vaccinated participants.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	30 participants	30 participants	30 participants	90 participants
	<=18 years	30 100.0%	30 100.0%	0 0.0%	60 66.7%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	30 100.0%	30 33.3%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	30 participants	30 participants	30 participants	90 participants
		1.86 (0.29)	5.43 (1.45)	71.83 (5.16)	26.38 (32.50)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	30 participants	30 participants	30 participants	90 participants
	Female	18 60.0%	13 43.3%	16 53.3%	47 52.2%
	Male	12 40.0%	17 56.7%	14 46.7%	43 47.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	30 participants	30 participants	30 participants	90 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	2 6.7%	0 0.0%	2 2.2%
	White	29 96.7%	25 83.3%	30 100.0%	84 93.3%
	More than one race	1 3.3%	3 10.0%	0 0.0%	4 4.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Aged 6 Months to < 9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Description	Blood samples were collected from participants before first vaccination at Visit 1 (Day 0; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Time Frame	Visit 1 (Day 0; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3

Outcome Measure Data

Analysis Population Description

Analysis was performed on all vaccinated participants i.e. the participants who have received at least 1 dose of the study vaccine. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months	Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years
Arm/Group Description:	Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.	Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
Overall Number of Participants Analyzed	28	30
Measure Type: Count of Participants; Unit of Measure: Participants
Visit 1	28 100.0%	30 100.0%
Visit 2	22 78.6%	28 93.3%
Visit 3	3 10.7%	2 6.7%

2. Primary Outcome

Title	Number of Participants Aged >= 65 Years Who Provided Serum Samples for Analysis: Group 3
Description	Blood samples were collected from participants before vaccination at Visit 1 (Day 0; pre-vaccination) and 21 days after vaccination (Visit 2). Collected blood samples were provided to CBER for further analysis by WHO, CDC, and FDA to support formulation recommendations for subsequent influenza vaccines.
Time Frame	Visit 1 (Day 0; pre-vaccination) and 21 days post-vaccination (Visit 2)

Outcome Measure Data

Analysis Population Description

Analysis was performed on all vaccinated participants.

Arm/Group Title	Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Arm/Group Description:	Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
Overall Number of Participants Analyzed	30
Measure Type: Count of Participants; Unit of Measure: Participants
Visit 1	30 100.0%
Visit 2	30 100.0%

Adverse Events

Time Frame	Serious adverse events data were collected from Day 0 (post-vaccination) up to end of the study (i.e., up to Day 21 for adult participants [>= 65 years], Day 28 for child participants [6 to < 9 years] who had received 1 dose and Day 56 for participants who had received 2 doses).
Adverse Event Reporting Description	Non-serious adverse event data were not planned to be collected in this study. Analysis was performed on all enrolled and vaccinated participants.
Arm/Group Title	Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months		Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years		Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Arm/Group Description	Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.		Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.		Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
All-Cause Mortality
	Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months		Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years		Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/30 (0.00%)		0/30 (0.00%)		0/30 (0.00%)
Serious Adverse Events
	Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months		Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years		Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/30 (3.33%)		0/30 (0.00%)		0/30 (0.00%)
Infections and infestations
Parainfluenzae virus infection † 1	1/30 (3.33%)	1	0/30 (0.00%)	0	0/30 (0.00%)	0
1 Term from vocabulary, MedDRA 21.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months		Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years		Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0		0/0		0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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: Trial Transparency Team
• 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: NCT04109222
• Other Study ID Numbers: GRC00097; U1111-1225-1118 ( Other Identifier: UTN )
• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Results First Submitted: November 20, 2020
• Results First Posted: December 17, 2020
• Last Update Posted: March 28, 2022