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
  Purpose

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.

Condition Intervention Phase
Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 4292
Study Start Date: October 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
Active Comparator: Fluzone Intramuscular Vaccine
Participants will receive a dose of influenza intramuscular vaccine
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Name: Fluzone®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772109

  Show 49 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00772109     History of Changes
Other Study ID Numbers: FID31
Study First Received: October 13, 2008
Results First Received: July 16, 2011
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Fluzone®
Adults

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014