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Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00772109
  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 III

MedlinePlus related topics: Flu
Drug Information available for: Influenza Vaccines Fluvirin
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3900
Study Start Date: October 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Influenza vaccine Lot 1
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
2: Experimental
Influenza vaccine Lot 2
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
3: Experimental
Influenza vaccine Lot 3
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
4: Active Comparator Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular

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

  Show 49 Study Locations
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: FID31
Study First Received: October 13, 2008
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00772109  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009