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 Description

Brief Summary:

This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.

Condition or disease	Intervention/treatment	Phase
Influenza (Healthy Volunteers)	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	Phase 4

Detailed Description:

Study duration per participant was approximately 28 days for participants with 6 months to < 9 years of age, and 21 days for participants >= 65 years of age, including 1 to 3 visits (1 or 2 vaccination visits) and 1 or 2 telephone calls, depending on study Group.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Collection of Serum Samples From Children 6 Months to < 9 Years of Age Who Received Fluzone® Quadrivalent and Adults ≥ 65 Years of Age Who Received Fluzone® High-Dose Quadrivalent, Influenza Vaccines, 2021-2022 Formulations
• Actual Study Start Date: September 8, 2021
• Actual Primary Completion Date: November 10, 2021
• Actual Study Completion Date: November 10, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months; Participants aged 6 to <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.	Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation; Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM); Other Name: Fluzone® Quadrivalent
Experimental: Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years; 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.	Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation; Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM); Other Name: Fluzone® Quadrivalent
Experimental: Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years; Participants aged >= 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.	Biological: Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation; Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM); Other Name: Fluzone High-Dose Quadrivalent

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 [ 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) ]
   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.
2. Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3 [ Time Frame: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 6 Months and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Aged 6 months to < 9 years or >= 65 years of age on the day of first study vaccination (study product administration).
• For infants and toddlers, born at full term of pregnancy (>=37 weeks) or born after a gestation period of 27 through 36 weeks.
• For participants 6 to < 12 months of age, born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 5.5 pound (lbs) (2.5 kilogram [kg]).
• Informed consent form (ICF) has been signed and dated by participants >= 65 years of age.
• Assent form has been signed and dated by participants 7 to < 9 years of age, and ICF has been signed and dated by parent(s) or another legally acceptable representative for participants 6 months to < 9 years of age.
• Participants or participant and parent/legally acceptable representative (of participants 6 months to < 9 years of age) were able to attend all scheduled visits and complied with all study procedures.

Exclusion Criteria:

• Participants are excluded from the study if any of the following criteria apply:
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the 3 months preceding planned inclusion).
• Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances.
• Thrombocytopenia, contraindicating IM injection, at the discretion of the Investigator.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
• Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion.
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of study intervention administration or febrile illness (temperature >= 100.4° Fahrenheit [38.0° Celsius]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
• History of serious adverse reaction to any influenza vaccine.
• Personal history of Guillain-Barré syndrome.
• Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
• Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
• Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
• Receipt of any vaccine in the 30 days preceding the first study intervention administration, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
• Previous vaccination against influenza (in the 2021-2022 influenza season) with an investigational or marketed vaccine.
• Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
• Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.

Note: Participants might be considered eligible for enrollment if no intervention for the other study occurred within the 30 days prior to the first study vaccination and none were planned before the participant would complete safety surveillance for the present study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Contacts and Locations

Locations

United States, Kentucky

Investigational Site Number :8400001

Bardstown, Kentucky, United States, 40004

United States, Utah

Investigational Site Number :8400002

Salt Lake City, Utah, United States, 84121

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi Pasteur, a Sanofi Company

  Study Documents (Full-Text)

Documents provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Study Protocol and Statistical Analysis Plan  [PDF] July 21, 2021

More Information

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

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs