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

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ClinicalTrials.gov Identifier: NCT00772109
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : August 10, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 13, 2008
First Posted Date  ICMJE October 15, 2008
Results First Submitted Date  ICMJE July 16, 2011
Results First Posted Date  ICMJE August 10, 2011
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2011)
  • Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines [ Time Frame: Baseline (Day 0) and 28 Days post-vaccination ]
    The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
  • Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: 28 Days post-vaccination ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2008)
  • Immunogenicity: To provide information concerning the immunogenicity of an investigational Fluzone vaccine. [ Time Frame: 28 days post vaccination ]
  • Safety: To provide information concerning the safety of an investigational Fluzone vaccine. [ Time Frame: 28 days post-vaccination and entire study duration ]
Change History Complete list of historical versions of study NCT00772109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2011)
  • Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM [ Time Frame: Before and 28 Days post-vaccination ]
    The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40.
  • Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 0 up to 7 Days post vaccination ]
    Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
Official Title  ICMJE 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
Brief Summary

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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Orthomyxoviridae Infection
  • Influenza
  • Myxovirus Infection
Intervention  ICMJE
  • 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 Name: Fluzone®
Study Arms  ICMJE
  • Experimental: Fluzone Intradermal Vaccine Lot 1
    Participants will receive a dose of Influenza intradermal vaccine Lot 1
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
  • Experimental: Fluzone Intradermal Vaccine Lot 2
    Participants will receive a dose of Influenza intradermal vaccine Lot 2
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
  • Experimental: Fluzone Intradermal Vaccine Lot 3
    Participants will receive a dose of Influenza intradermal vaccine Lot 3
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
  • Active Comparator: Fluzone Intramuscular Vaccine
    Participants will receive a dose of influenza intramuscular vaccine
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2011)
4292
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2008)
3900
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00772109
Other Study ID Numbers  ICMJE FID31
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP