Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.

Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccines 2012-2013 Formulation (Intradermal and Intramuscular Route)

The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).

Primary Objective:

• To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.

Observational Objectives:

• To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
• To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
• To submit remaining available sera from subjects given Fluzone vaccine 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 selection and recommendation of strains for subsequent years' influenza vaccines.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation; Biological: Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation; Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation

Detailed Description

Participants 18 to < 65 years of age will be randomized to receive a dose of either Fluzone or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 21 days.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33432
    • South Miami, Florida, United States, 33143
  • Iowa
    • Council Bluffs, Iowa, United States, 51503
  • Louisiana
    • Metairie, Louisiana, United States, 70006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is ≥ 18 years of age on the day of inclusion
• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

• History of serious adverse reaction to any influenza vaccine
• Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2
• Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study
• Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
• Prior vaccination with any 2012 - 2013 formulation of influenza vaccine
• Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone, Fluzone Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information)
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
• Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
• Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine
• Personal history of Guillain-Barré syndrome
• 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)
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
• Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the subject
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures
• Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of vaccination. A prospective subject 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, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluzone vaccine (Group 1); Adults 18 to < 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly	Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation; 0.5 mL, Intramuscular; Other Names: Fluzone® (2012-2013 Formulation)
Experimental: Fluzone Intradermal vaccine (Group 2); Adults 18 to < 65 years of age randomized to receive one dose of Fluzone Intradermal vaccine intradermally	Biological: Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation; 0.1 mL, Intradermal; Other Names: Fluzone® Intradermal (2012-2013 Formulation)
Experimental: Fluzone vaccine (Group 3); Adults ≥ 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly	Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation; 0.5 mL, Intramuscular; Other Names: Fluzone® (2012-2013 Formulation)
Active Comparator: Fluzone High-Dose Vaccine (Group 4); Adults ≥ 65 years of age randomized to receive one dose of Fluzone High-Dose vaccine intramuscularly	Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation; 0.5 mL, Intramuscular; Other Names: Fluzone® High-Dose (2012-2013 Formulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine	Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.	Day 0 up to Day 7 post-vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine	Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.	Day 0 (pre-vaccination) up to Day 21 post-vaccination
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine	Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).	Day 0 (pre-vaccination) and Day 21 post-vaccination
Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine	Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.	Day 0 (pre-vaccination) and Day 21 post-vaccination
Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine	Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.	Day 0 (pre-vaccination) and Day 21 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): November 3, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Influenza; Influenza virus vaccine; Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation; Fluzone® High-Dose (Influenza Virus Vaccine) 2012-2013 Formulation; Trivalent Inactivated Influenza Vaccine; Fluzone® Intradermal (Influenza Virus Vaccine) 2012-2013 Formulation
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: GRC50; U 1111-1124-8310 (Other Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No