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

NCT ID: NCT04109222

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2019-12-10

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.

Detailed Description

All participants received 1 intramuscular injection of the study vaccine associated with their assigned group at Visit 1. For participants 6 months to < 9 years of age for whom 2 doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second intramuscular injection of Fluzone Quadrivalent vaccine was administered at Visit 2 (28 days after Visit 1).

Blood specimens were obtained from all participants prior to the first vaccination:

• At Visit 1 (Day 0) and 28 days following the final vaccination (Visit 2, if no study vaccine was administered at Visit 2; or Visit 3, if a second dose of study vaccine was administered at Visit 2), for participants 6 months to < 9 years of age (Group 1 and Group 2)
• At Visit 1 and 21 (window, 21-28) days post-vaccination (Visit 2), for participants greater than or equal to (>=) 65 years of age (Group 3) Serious Adverse Events (SAEs), suspected unexpected serious adverse reactions (SUSARs), or Adverse Event of Special Interests (AESIs) were collected from Visit 1 through Visit 2 for participants receiving 1 dose of study vaccine, and from Visit 1 through Visit 3 for participants receiving 2 doses of study vaccine.

Study duration per participant was approximately 28 days for participants 6 months to less than (<) 9 years of age, and 21 days for participants >= 65 years of age.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

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 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

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

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

Group Type: EXPERIMENTAL

Fluzone High-Dose vaccine, 2019-2020 formulation

Intervention Type: BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Interventions

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

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Intervention Type: BIOLOGICAL

Fluzone High-Dose vaccine, 2019-2020 formulation

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone® Quadrivalent, No Preservative

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
• Receipt of immune globulins, blood, or blood-derived products in the 3 months preceding planned inclusion.
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the 6 months preceding planned inclusion; 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 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.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
• 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.
• Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 83 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Investigational Site Number 8400002

Bardstown, Kentucky, United States

Investigational Site Number 8400001

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25269&tenant=MT_SNY_9011

GRC00097 Plain Language Results Summary

Other Identifiers

U1111-1225-1118

Identifier Type: OTHER

Identifier Source: secondary_id

GRC00097

Identifier Type: -

Identifier Source: org_study_id