Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.

Primary Objective:

• To demonstrate lot consistency of the Fluzone ID manufacturing process.
• To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

• To describe the safety profile of subjects who receive of Fluzone ID.

Study Overview

• Status: Completed
• Conditions: Influenza; Orthomyxoviridae Infection; Myxovirus Infection
• Intervention / Treatment: Biological: Influenza Virus Vaccine USP Trivalent Types A and B; Biological: Influenza Virus Vaccine USP Trivalent Types A and B

Detailed Description

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

• Study Type: Interventional
• Enrollment (Actual): 4292
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Castellana Gardens, Carolina, Puerto Rico, 00983
  • San Juan, Puerto Rico, 00918
  • San Juan, Puerto Rico, 00935
• United States
  • Alabama
    • Hoover, Alabama, United States, 35216
    • Huntsville, Alabama, United States, 35802
    • Mobile, Alabama, United States, 36608
  • Arizona
    • Chandler, Arizona, United States, 85224
    • Mesa, Arizona, United States, 85213
    • Phoenix, Arizona, United States, 85014
    • Tucson, Arizona, United States, 85711
  • California
    • Fountain Valley, California, United States, 92708
    • San Diego, California, United States, 92103
  • Connecticut
    • Milford, Connecticut, United States, 06460
  • Florida
    • Melbourne, Florida, United States, 32935
    • Pembroke Pines, Florida, United States, 33024
    • Pinellas Park, Florida, United States, 33781
  • Idaho
    • Boise, Idaho, United States, 83642
  • Illinois
    • Chicago, Illinois, United States, 60610
  • Iowa
    • Iowa City, Iowa, United States, 52242
  • Kansas
    • Wichita, Kansas, United States, 67207
  • Kentucky
    • Lexington, Kentucky, United States, 40509
    • Madisonville, Kentucky, United States, 42431
  • Maryland
    • Rockville, Maryland, United States, 20850
  • Missouri
    • Kansas City, Missouri, United States, 64114
    • Springfield, Missouri, United States, 65802
    • St. Louis, Missouri, United States, 63104
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
  • New York
    • Binghamton, New York, United States, 13901
    • Endwell, New York, United States, 13760
    • Rochester, New York, United States, 14621
    • Rochester, New York, United States, 14609
  • North Carolina
    • Cary, North Carolina, United States, 27518
    • Raleigh, North Carolina, United States, 27609
  • Ohio
    • Cincinnati, Ohio, United States, 45249
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102
    • Bensalem, Pennsylvania, United States, 19020
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
  • Tennessee
    • Nashville, Tennessee, United States, 37203
  • Texas
    • Austin, Texas, United States, 78705
    • Fort Worth, Texas, United States, 76107
    • Fort Worth, Texas, United States, 76135
    • Galveston, Texas, United States, 77555
    • San Angelo, Texas, United States, 76904
  • Utah
    • Salt Lake, Utah, United States, 84109
    • Salt Lake City, Utah, United States, 84121
    • West Jordan, Utah, United States, 84088
  • Washington
    • Seattle, Washington, United States, 98101
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria :

• Aged 18 to 64 years on the day of vaccination.
• Informed consent form signed and dated.
• Able to attend all scheduled visits and to comply with all trial procedures.
• For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Exclusion Criteria :

• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
• For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.
• Breast-feeding woman.
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
• Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
• Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
• Receipt of any vaccination in the 4 weeks preceding the trial vaccination.
• Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
• Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.
• Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
• Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for >=5 years).
• Personal or family history of Guillain-Barré Syndrome.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluzone Intradermal Vaccine Lot 1; Participants will receive a dose of Influenza intradermal vaccine Lot 1	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone®
Experimental: Fluzone Intradermal Vaccine Lot 2; Participants will receive a dose of Influenza intradermal vaccine Lot 2	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone®
Experimental: Fluzone Intradermal Vaccine Lot 3; Participants will receive a dose of Influenza intradermal vaccine Lot 3	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone®
Active Comparator: Fluzone Intramuscular Vaccine; Participants will receive a dose of influenza intramuscular vaccine	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay	Baseline (Day 0) and 28 Days post-vaccination
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.	28 Days post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40.	Before and 28 Days post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine	Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.	Day 0 up to 7 Days post vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

General Publications

• Gorse GJ, Falsey AR, Fling JA, Poling TL, Strout CB, Tsang PH. Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Vaccine. 2013 May 1;31(19):2358-65. doi: 10.1016/j.vaccine.2013.03.008. Epub 2013 Mar 13.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 13, 2008
• First Submitted That Met QC Criteria: October 13, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Influenza; Adults; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Fluzone®
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FID31