Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

• ClinicalTrials.gov Identifier: NCT04551677
• Recruitment Status: Completed
• First Posted: September 16, 2020
• Results First Posted: July 13, 2021
• 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 (Healthy Volunteers)
• Interventions: Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation; Biological: Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation
• Enrollment: 90

Participant Flow

Recruitment Details	Participants were enrolled from 16 September 2020 to 10 October 2020 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 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	29	31	30
Completed	29	31	30
Not Completed	0	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		29	31	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	29 participants	31 participants	30 participants	90 participants
	<=18 years	29 100.0%	31 100.0%	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	29 participants	31 participants	30 participants	90 participants
		1.65 (0.518)	5.13 (1.75)	73.0 (4.03)	26.6 (33.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	31 participants	30 participants	90 participants
	Female	13 44.8%	12 38.7%	16 53.3%	41 45.6%
	Male	16 55.2%	19 61.3%	14 46.7%	49 54.4%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	31 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	4 13.8%	1 3.2%	0 0.0%	5 5.6%
	White	23 79.3%	30 96.8%	30 100.0%	83 92.2%
	More than one race	2 6.9%	0 0.0%	0 0.0%	2 2.2%
	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/Visit 3

Outcome Measure Data

Analysis Population Description

Analysis was performed on all vaccinated participants i.e. the participants who had received at least 1 dose of the study vaccine. 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		29	31
Measure Type: Count of Participants; Unit of Measure: Participants
Visit 1	Number Analyzed	29 participants	31 participants
		29	31
Visit 2	Number Analyzed	15 participants	30 participants
		15	30
Visit 3	Number Analyzed	14 participants	1 participants
		14	1

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	Serious adverse events 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 had received 1 dose and up to 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 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	0/29 (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	0/29 (0.00%)	0/31 (0.00%)	0/30 (0.00%)
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 Quadrivalent Influenza Vaccine: >=65 Years
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
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 participant 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: NCT04551677
• Other Study ID Numbers: GRC00101; U1111-1238-1821 ( Other Identifier: UTN )
• First Submitted: August 27, 2020
• First Posted: September 16, 2020
• Results First Submitted: June 21, 2021
• Results First Posted: July 13, 2021
• Last Update Posted: March 28, 2022