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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01691339
First received: September 19, 2012
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.

Condition Intervention Phase
Influenza
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccines 2012-2013 Formulation (Intradermal and Intramuscular Route)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 (pre-vaccination) up to Day 21 post-vaccination ] [ Designated as safety issue: No ]
    Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.

  • Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ] [ Designated as safety issue: No ]
    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).

  • Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ] [ Designated as safety issue: No ]
    Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.


Enrollment: 200
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691339

Locations
United States, Florida
Boca Raton, Florida, United States, 33432
South Miami, Florida, United States, 33143
United States, Iowa
Council Bluffs, Iowa, United States, 51503
United States, Louisiana
Metairie, Louisiana, United States, 70006
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01691339     History of Changes
Other Study ID Numbers: GRC50, U 1111-1124-8310
Study First Received: September 19, 2012
Results First Received: August 29, 2013
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
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:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014