Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

NCT02908269 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GRC71U1111-1174-4738
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and in adults 18 to \< 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age. Primary Observational Objectives

• To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. Observational Objectives:
• To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
• To submit available sera from approximately 90 participants (30 participants 3 to \< 9 years of age and 30 participants 18 to \< 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to 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

Keywords

Influenza; Fluzone® Quadrivalent, Influenza Vaccine (2016-2017 formulation); Fluzone® High-Dose, Influenza Vaccine (2016-2017 formulation)

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age)

  Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema \& swelling (Grade 1: \>0 to \<25 mm;Grade 2: ≥ 25 to \< 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise \& myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site \& systemic reactions are reported; number of participants with Grade 3 solicited injection-site \& systemic reactions are also reported.

  Within 7 days after any vaccination

• Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years)

  Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema \& swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: \>100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise \& myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site \& systemic reactions are reported; number of participants with Grade 3 solicited injection-site \& systemic reactions are also reported.

  Within 7 days after any vaccination

Secondary Outcomes (6)

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years)

  Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years)

  Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years)

  Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)

• Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years)

  Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)

• Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years)

  Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)

Study Arms (3)

Fluzone Quadrivalent Vaccine Group 1: 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. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.

Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative

Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years

EXPERIMENTAL

Participants aged 18 to \< 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.

Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative

Fluzone High-Dose Vaccine Group 3: ≥ 65 Years

EXPERIMENTAL

Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.

Biological: Fluzone High-Dose, vaccine, 2016-2017 formulation

Interventions

Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone® Quadrivalent, Influenza Vaccine

Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years

Fluzone High-Dose, vaccine, 2016-2017 formulation BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone® High-Dose Influenza Vaccine

Fluzone High-Dose Vaccine Group 3: ≥ 65 Years

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 3 to \<9 years or adult aged ≥ 18 years on the day of first study vaccination (study product administration) .
• Informed consent form had been signed and dated by participants ≥ 18 years of age.
• Assent form had been signed and dated by participants 7 to \<9 years of age, and informed consent form (ICF) has been signed and dated by parent(s) or guardian(s) for participants 3 to \<9 years of age.
• Participant and parent/guardian (of participants 3 to \<9 years of age) were able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
• Participation at the time of study enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 30 days preceding the first trial 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 2016-2017 influenza season) with either the trial vaccine or another vaccine.
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
• Thrombocytopenia, which may 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, is at a stage where it might interfere with trial 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°F \[38.0°C\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study (participants ≥18 years of age) or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (all participants).
• History of serious adverse reaction to any influenza vaccine.
• Personal history of Guillain-Barré syndrome.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Bardstown, Kentucky, 40004, United States

Location

Unknown Facility

Metairie, Louisiana, 70002, United States

Location

Related Links

• Related Info

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: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 20, 2016
• Study Start: September 15, 2016
• Primary Completion: December 9, 2016
• Study Completion: December 9, 2016
• Last Updated: March 29, 2022
• Results First Posted: January 8, 2018

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)