Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively

NCT04109222 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GRC00097U1111-1225-1118
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study was to provide sera (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.

Conditions

Influenza

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 before first vaccination at Visit 1 (Day 0; 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 0; 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 before vaccination at Visit 1 (Day 0; 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 0; 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 0. 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), 2019-2020 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 0. 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), 2019-2020 formulation

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

EXPERIMENTAL

Participants aged \>=65 years received a of 0.5-mL dose of Fluzone high-dose vaccine, intramuscularly, at Day 0.

Biological: Fluzone High-Dose vaccine, 2019-2020 formulation

Interventions

Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Also known as: Fluzone® Quadrivalent, No Preservative

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

Fluzone High-Dose vaccine, 2019-2020 formulation BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

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

Eligibility Criteria

• Age: 6 Months - 83 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An individual who fulfilled all of the following criteria were eligible for study enrollment:
• 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 pounds (2.5 kilograms).
• Informed consent form (ICF) had been signed and dated by participants \>= 65 years of age.
• Assent form had been signed and dated by participants 7 to \< 9 years of age, and ICF had been signed and dated by parent(s) or guardian(s) for participants 6 months to \< 9 years of age.
• Participant and parent/guardian (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:

• An individual who fulfilled any of the following criteria were excluded from study enrollment:
• 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.
• Receipt of any vaccine in the 30 days preceding the first study vaccination, 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 2019-2020 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.
• Thrombocytopenia, which might be a contraindication for intramuscular 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 were 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 participants 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Investigational Site Number 8400002

Bardstown, Kentucky, 40004, United States

Location

Investigational Site Number 8400001

Salt Lake City, Utah, 84121, United States

Location

Related Links

• GRC00097 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral 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 26, 2019
• First Posted: September 30, 2019
• Study Start: September 30, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: September 12, 2025
• Results First Posted: December 17, 2020

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)