Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Intervention: TIV; TIVf; Comparator TIV
Intervention description: Investigational egg-derived trivalent subunit influenza vaccine.; US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.; US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children <4 years.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3116.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: seasonal influenza, vaccine

Summary:

      This study will evaluate the safety and immunogenicity in healthy children and adolescents
      after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 3 to 17 years, in good health as determined by medical history,
             physical examination and clinical judgment of the investigator

          -  Documented consent provided by parents or legal guardians

          -  For individuals 8 years of age and older, informed assent to participate in the study
             after the nature of the study had been explained to them in terms they could
             understand

          -  Individuals and parents/guardians who were able to comply with all study procedures
             and were available for all clinic visits scheduled in the study

        Exclusion Criteria:

          -  Parents or legal guardians and individuals who are not able to comprehend and to
             follow all required study procedures for the whole period of the study

          -  Parents or legal guardians and individuals providing assent who do not consent to the
             retention of the subject's serum samples after study completion

          -  Individuals with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, may have interfered with the subject's ability to
             participate in the study

          -  Individuals with history or any illness that, in the opinion of the investigator,
             might have interfered with the results of the study or posed additional risk to the
             subjects due to participation in the study

          -  History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to
             influenza viral proteins, latex, to any excipients, and to eggs (including ovalbumin),
             chicken protein, influenza viral protein, kanamycin, neomycin sulphate,
             cetyltrimethylammonium bromide (CTAB), polysorbate 80, neomycin, polymixin,
             formaldehyde, thimerosal, beta propiolactone, or nonoxynol-9

          -  History of any serious disease, such as:

               1. cancer

               2. history of serious chronic, rheumatologic, neurologic and hematologic diseases

               3. history of underlying medical condition such as inborn errors of metabolism

          -  Known or suspected impairment/alteration of immune function, including:

               1. chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled,
                  intranasal, or topical corticosteroids is allowed)

               2. receipt of immunostimulants within 60 days prior to Visit 1

               3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
                  derivates within 3 months prior to Visit 1 or planned during the full length of
                  the study

               4. HIV infection or HIV-related disease

          -  Pregnant or breast-feeding female and any positive or indeterminate pregnancy test

          -  Received an influenza vaccine within 6 months prior to Visit 1

          -  Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1

          -  Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for
             live vaccines) prior to enrollment in this study

          -  Experienced a fever and/or any acute illness within 3 days prior to each study
             vaccination