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

NCT05050318 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GRC00102U1111-1266-5255
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza Immunization; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2

  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.

  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)

• Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3

  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.

  Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)

Study Arms (3)

Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months

EXPERIMENTAL

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

Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years

EXPERIMENTAL

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

Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years

EXPERIMENTAL

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

Interventions

Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation BIOLOGICAL

Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)

Also known as: Fluzone® Quadrivalent

Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months; Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years

Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation BIOLOGICAL

Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)

Also known as: Fluzone High-Dose Quadrivalent

Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Investigational Site Number :8400001

Bardstown, Kentucky, 40004, United States

Location

Investigational Site Number :8400002

Salt Lake City, Utah, 84121, United States

Location

Related Links

• GRC00102 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Vaccines, Combined

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 20, 2021
• Study Start: September 8, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: September 12, 2025
• Results First Posted: September 14, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)