Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    FID33
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01011049
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : August 11, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza Virus Vaccine USP Trivalent Types A and B Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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

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
0.5 mL, Intramuscular
Other Name: 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
0.5 mL, Intramuscular
Other Name: 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




Primary Outcome Measures :
  1. Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 0 through Day 7 post-vaccination ]
    Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).


Secondary Outcome Measures :
  1. Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 0 and Day 28 post-vaccination ]
    Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.

  2. Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. [ Time Frame: Day 28 post-vaccination ]
    Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.

  3. Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 28 post vaccination ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011049


Locations
Layout table for location information
United States, Alabama
Hoover, Alabama, United States, 35216
Huntsville, Alabama, United States, 35802
Mobile, Alabama, United States, 36608
United States, Arizona
Chandler, Arizona, United States, 85224
Mesa, Arizona, United States, 85213
Tempe, Arizona, United States, 85282
Tucson, Arizona, United States, 85711
United States, California
Fountain Valley, California, United States, 92708
San Diego, California, United States, 92103
United States, Connecticut
Milford, Connecticut, United States, 06460
United States, Florida
Melbourne, Florida, United States, 32935
Pembroke Pines, Florida, United States, 33024
Pinellas Park, Florida, United States, 33781
United States, Idaho
Boise, Idaho, United States, 83642
United States, Illinois
Chicago, Illinois, United States, 60610
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Wichita, Kansas, United States, 67207
United States, Kentucky
Lexington, Kentucky, United States, 40509
Madisonville, Kentucky, United States, 42431
United States, Maryland
Rockville, Maryland, United States, 20850
United States, Missouri
Kansas City, Missouri, United States, 64114
Springfield, Missouri, United States, 65802
St. Louis, Missouri, United States, 63104
United States, New Mexico
Albuquerque, New Mexico, United States, 87108
United States, New York
Binghamton, New York, United States, 13901
Endwell, New York, United States, 13760
Rochester, New York, United States, 14609
Rochester, New York, United States, 14621
United States, North Carolina
Cary, North Carolina, United States, 27518
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cincinnati, Ohio, United States, 45249
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18102
Bensalem, Pennsylvania, United States, 19020
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Austin, Texas, United States, 78705
Fort Worth, Texas, United States, 76107
Fort Worth, Texas, United States, 76135
San Angelo, Texas, United States, 76904
United States, Utah
Salt Lake City, Utah, United States, 84121
Salt Lake, Utah, United States, 84109
West Jordan, Utah, United States, 84088
United States, Wisconsin
Marshfield, Wisconsin, United States, 54449
Puerto Rico
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Medical Director Sanofi Pasteur Inc.
Additional Information:
Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01011049    
Other Study ID Numbers: FID33
UTN: U1111-1111-5095 ( Other Identifier: WHO )
First Posted: November 11, 2009    Key Record Dates
Results First Posted: August 11, 2011
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Fluzone Vaccine
Intradermal Injections
Adults
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs