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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00772109
First received: October 13, 2008
Last updated: January 9, 2014
Last verified: January 2014

October 13, 2008
January 9, 2014
October 2008
May 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.

  • Immunogenicity: To provide information concerning the immunogenicity of an investigational Fluzone vaccine. [ Time Frame: 28 days post vaccination ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety of an investigational Fluzone vaccine. [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00772109 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Orthomyxoviridae Infection
  • Influenza
  • Myxovirus Infection
  • 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®
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4292
July 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00772109
FID31
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc.
Sanofi
January 2014

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