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Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00391391
  Purpose

Primary Objective:

To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Secondary Objectives:

  • To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
  • To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Condition Intervention Phase
Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Phase II

MedlinePlus related topics: Flu
Drug Information available for: Influenza Vaccines Fluvirin
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: October 2006
Estimated Study Completion Date: September 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (infant dose)
2: Experimental
Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (children dose)
3: Active Comparator
Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (infant dose)
4: Active Comparator
Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (children dose)

  Eligibility

Ages Eligible for Study:   6 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
  • Subject is healthy, as determined by medical history.
  • Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
  • Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Personal or family history of Guillain-Barré Syndrome.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Received blood or blood-derived products in the previous 3 months.
  • Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
  • Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
  • Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • Acute medical illness, with or without fever, within the last 72 hours or an oral temperature >= 37.5 °C (99.5 °F) or rectal temperature of >= 38°C (100.4 °F) at the time of enrollment.
  • History of seizures.
  • Received antibiotics therapy within 72 hours preceding the trial vaccination.
  • Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
  • Any condition, which in the opinion of the investigator would pose a health risk to the participant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391391

Locations
United States, Arkansas
Little Rock, Arkansas, United States
Harrisburg, Arkansas, United States
Trumann, Arkansas, United States
United States, California
Paramount, California, United States
Bellflower, California, United States
Downey, California, United States
Fountain Valley, California, United States
United States, Kentucky
Owensboro, Kentucky, United States
United States, Louisiana
Bossier City, Louisiana, United States
Shreveport, Louisiana, United States
United States, Minnesota
Brainerd, Minnesota, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
Wexford, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Erie, Pennsylvania, United States
United States, Texas
Fort Worth, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

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

Responsible Party: sanofi aventis ( sanofi pasteur )
Study ID Numbers: FID07
Study First Received: October 23, 2006
Last Updated: May 14, 2008
ClinicalTrials.gov Identifier: NCT00391391  
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Infants
children.

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 15, 2009