Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively (GRC00097)

• ClinicalTrials.gov Identifier: NCT04109222
• Recruitment Status: Completed
• First Posted: September 30, 2019
• Results First Posted: December 17, 2020
• Last Update Posted: March 28, 2022
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation; Biological: Fluzone High-Dose vaccine, 2019-2020 formulation	Phase 4

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.

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, Influenza Vaccines, 2019-2020 Formulations
• Actual Study Start Date: September 30, 2019
• Actual Primary Completion Date: December 10, 2019
• Actual Study Completion Date: December 10, 2019

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 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; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Other Name: Fluzone® Quadrivalent, No Preservative
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 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; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Other Name: Fluzone® Quadrivalent, No Preservative
Experimental: 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.	Biological: Fluzone High-Dose vaccine, 2019-2020 formulation; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

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 0; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3 ]
   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.
2. Number of Participants Aged >= 65 Years Who Provided Serum Samples for Analysis: Group 3 [ Time Frame: Visit 1 (Day 0; pre-vaccination) and 21 days post-vaccination (Visit 2) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 83 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Kentucky

Investigational Site Number 8400002

Bardstown, Kentucky, United States, 40004

United States, Utah

Investigational Site Number 8400001

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] August 6, 2019

More Information

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT04109222
• Other Study ID Numbers: GRC00097; U1111-1225-1118 ( Other Identifier: UTN )
• First Posted: September 30, 2019
• Results First Posted: December 17, 2020
• Last Update Posted: March 28, 2022
• Last Verified: March 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

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