Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

• ClinicalTrials.gov Identifier: NCT05050318
• Recruitment Status: Completed
• First Posted: September 20, 2021
• Results First Posted: September 14, 2022
• Last Update Posted: September 14, 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 (Healthy Volunteers)
• Interventions: Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation; Biological: Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
• Enrollment: 90

Participant Flow

Recruitment Details	Participants were enrolled from 08 September 2021 to 20 September 2021 at 2 active sites in the United States.
Pre-assignment Details	A total of 90 participants were enrolled 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 Quadrivalent Influenza Vaccine: >=65 Years
Arm/Group Description	Participants aged 6 to less than (<) 36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. 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 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.	Participants aged greater than or equal to (>=) 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
Period Title: Overall Study
Started	29	31	30
Vaccinated	28	31	30
Completed	28	31	30
Not Completed	1	0	0
Reason Not Completed
Protocol Deviation	1	0	0

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 Quadrivalent 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 1. 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 1. 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 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.	Total of all reporting groups
Overall Number of Baseline Participants		28	31	30	89
Baseline Analysis Population Description		Analysis was performed on all vaccinated participants which included all participants who had received at least 1 dose of the study vaccine.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	31 participants	30 participants	89 participants
	<=18 years	28 100.0%	31 100.0%	0 0.0%	59 66.3%
	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 33.7%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	28 participants	31 participants	30 participants	89 participants
		1.83 (0.410)	4.81 (1.83)	73.3 (4.31)	27.0 (33.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	31 participants	30 participants	89 participants
	Female	11 39.3%	14 45.2%	15 50.0%	40 44.9%
	Male	17 60.7%	17 54.8%	15 50.0%	49 55.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	31 participants	30 participants	89 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	1 3.6%	3 9.7%	0 0.0%	4 4.5%
	White	26 92.9%	28 90.3%	30 100.0%	84 94.4%
	More than one race	1 3.6%	0 0.0%	0 0.0%	1 1.1%
	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 at first vaccination at Visit 1 (Day 1; 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 1; pre-vaccination) and 28 days post-final vaccination at Visit 2 (for participants with 1 vaccination)/Visit 3 (for participants with 2 vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was performed on all vaccinated participants. Here, 'number analyzed' = participants with available data for each specified category.

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 1. 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 1. 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	31
Measure Type: Count of Participants; Unit of Measure: Participants
Visit 1	Number Analyzed	28 participants	31 participants
		28 100.0%	31 100.0%
Visit 2	Number Analyzed	20 participants	31 participants
		20 100.0%	31 100.0%
Visit 3	Number Analyzed	7 participants	0 participants
		7 100.0%	0

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 at first vaccination at Visit 1 (Day 1; 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 1; 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 Quadrivalent Influenza Vaccine: >=65 Years
Arm/Group Description:	Participants aged >= 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
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	Reported adverse events (AE) data were collected from Visit 1 (Day 1) up to end of the study (i.e., up to Day 21 for adult participants [>=65 years], up to Day 28 for child participants [6 to <9 years] who received 1 dose and up to Day 56 for participants who received 2 doses).
Adverse Event Reporting Description	Analysis was performed on all 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 Quadrivalent 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 1. 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 1. 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 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
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 Quadrivalent Influenza Vaccine: >=65 Years
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/28 (0.00%)	0/31 (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 Quadrivalent Influenza Vaccine: >=65 Years
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/28 (0.00%)	0/31 (0.00%)	0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	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 Quadrivalent Influenza Vaccine: >=65 Years
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/28 (0.00%)	0/31 (0.00%)	0/30 (0.00%)

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 6#
• EMail: Contact-US@sanofi.com

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT05050318
• Other Study ID Numbers: GRC00102; U1111-1266-5255 ( Registry Identifier: ICTRP )
• First Submitted: September 3, 2021
• First Posted: September 20, 2021
• Results First Submitted: August 18, 2022
• Results First Posted: September 14, 2022
• Last Update Posted: September 14, 2022