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

NCT04551677 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GRC00101U1111-1238-1821
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objective: To provide serum samples (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the 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. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.

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/Visit 3

• 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), 2020-2021 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), 2020-2021 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), 2020-2021 formulation

Interventions

Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation BIOLOGICAL

Pharmaceutical form: 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), 2020-2021 formulation BIOLOGICAL

Pharmaceutical form: Suspension for injection in a pre-filled syringe, Route of administration: IM

Also known as: Fluzone High-Dose Quadrivalent

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

Eligibility Criteria

• Age: 6 Months - 84 Years
• 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 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 kilograms \[kg\]).
• Informed consent form (ICF) was signed and dated by participants \>=65 years of age.
• Assent form was signed and dated by participants 7 to \<9 years of age, and ICF was signed and dated by parent(s) or guardian(s) for participants 6 months to \< 9years of age.
• Participants and parent/guardian (of participants 6 months to \<9 years of age) were able to attend all scheduled visits and to comply with all study procedures.

You may not qualify if:

• \- 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 were considered eligible for enrollment if no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the participant would complete safety surveillance for the present study.
• Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants received 1 dose of influenza vaccine or Visit 3 for participants received 2 doses of influenza vaccine.
• Previous vaccination against influenza (in the 2020-2021 influenza season) with either study vaccine or another vaccine.
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to study vaccine or to a vaccine containing any of the same substances.
• Note: The list of vaccine components was included in the Prescribing Information for each study vaccine.
• Thrombocytopenia, which might be a contraindication for IM vaccination, at the discretion of the Investigator.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Current alcohol abuse or drug addiction.
• 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 planned vaccination or febrile illness (temperature \>=100.4 degree \[°\] Fahrenheit \[38.0° Celsius\]). A prospective participant not included in the study until the condition had resolved or the febrile event had subsided.
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) or in-laws of the Investigator or employee with direct involvement in the proposed study.
• 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.

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

• GRC00101 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: August 27, 2020
• First Posted: September 16, 2020
• Study Start: September 16, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: September 12, 2025
• Results First Posted: July 13, 2021

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)