Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Condition: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Intervention: Split, Inactivated, Trivalent Influenza Vaccine; Split, Inactivated, Trivalent Influenza Vaccine; Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Intervention description: Vaccine (infant dose); Vaccine (children dose); Vaccine (infant dose); Vaccine (children dose)
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 520.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Infants; children.

Summary:

      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.
    

Eligibility 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 human immunodeficiency virus (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.