Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

Safety and Immunogenicity of Revaccination With Influenza Vaccine in Healthy Adult Subjects Aged 18 to 64 Years Who Were Previously Vaccinated With Fluzone ID or Fluzone IM

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.

Primary Objective:

• To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants.

Secondary Objective:

• To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Study Overview

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

Detailed Description

All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.

• Study Type: Interventional
• Enrollment (Actual): 1250
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00918
• 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
    • Tempe, Arizona, United States, 85282
    • 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
    • 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
  • 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 in study FID33
• Enrolled in and completed study FID31 (NCT 00772109) and received the correct vaccine (Fluzone ID or Fluzone® IM) for the group to which they were randomized
• Informed consent form signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures
• For a woman 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 (observational trials will be allowed)
• 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
• Known human immunodeficiency virus (HIV), hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity.
• Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
• 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, (those who have localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years will not be excluded).
• Personal or family history of Guillain-Barré Syndrome

Temporary Exclusion Criteria:

A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:

• Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
• Signs and symptoms of an acute infectious respiratory illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Fluzone ID After Fluzone ID; Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31	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® 2009/2010 Northern Hemisphere Formulation
Experimental: Group 2: Fluzone IM After Fluzone ID; Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31	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® 2009/2010 Northern Hemisphere Formulation
Experimental: Group 3: Fluzone IM After Fluzone IM; Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31	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® 2009/2010 Northern Hemisphere Formulation
Experimental: Group 4: Fluzone ID After Fluzone IM; Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31	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® 2009/2010 Northern Hemisphere 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 After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine	Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).	Day 0 through Day 7 post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine	Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.	Day 0 and Day 28 post-vaccination
Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.	Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.	Day 28 post-vaccination
Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine	Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination.	Day 28 post vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: November 9, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

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; Fluzone Vaccine; Intradermal Injections
• 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: FID33; UTN: U1111-1111-5095 (Other Identifier: WHO)