Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Flublok® Quadrivalent Influenza Virus Vaccine; Fluarix Quadrivalent® Influenza Virus Vaccine
Intervention description: Intramuscular (Relevant year formulation); Intramuscular (Relevant year formulation)
Intervention MeSH terms: Hemagglutinins; Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 219.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention

Summary:

      Flublok was studied previously in children 6 -59 months of age and demonstrated less than
      satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the
      initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population
      will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This
      clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q
      in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study
      may support further studies in younger children.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female age 6-17 years (Cohort A: 6-8 years of age; Cohort B: 9-17 years of
             age)

          2. Female subjects of child-bearing potential (as defined by the onset of menses) must
             agree to avoid becoming pregnant and to use effective method of contraception or
             practice abstinence for at least 28 day prior to the first study vaccine
             administration, until the completion of the study. Female subjects of child-bearing
             potential must have a negative pregnancy test within 24 hours prior to vaccine
             administration.

          3. In good general health, as determined by medical history and targeted physical
             examination, if indicated

        The parent(s) or legal representative(s) of each potential subject must:

          1. Comprehend the study requirements and agree to comply with planned study procedures
             and visits

          2. Provide written consent prior to enrollment and initiation of any study procedures
             Pediatric assent will be obtained in accordance with the Institutional Review
             Board/Independent Ethics Committee determination.

        Exclusion Criteria:

          1. Known allergy to eggs, severe allergy (e.g. anaphylaxis) to other components of either
             vaccine or contraindications to receipt of the comparator IIV4

          2. Immunosuppression as a result of an underlying illness or treatment. Note: Subjects on
             nasal or topical steroids will be allowed

          3. Active neoplastic disease or a history of any malignancy.

          4. History of receiving influenza vaccine within the past 6 months or plans during the
             study to receive influenza vaccine outside of this study.

          5. History of receiving immunoglobulin or other blood product within the 3 months prior
             to enrollment in this study.

          6. Receipt of any non-study licensed vaccines within 2 weeks (for inactivated vaccines)
             or 4 weeks (for live vaccines) prior to enrollment in this study, or plans during the
             study to receive a licensed vaccine within 4 weeks of a study dose [See above for
             influenza vaccines].

          7. Acute or chronic medical condition that, in the opinion of the investigator, would
             render immunization unsafe or would interfere with the evaluation of immune responses

          8. History of severe reactions following immunization.

          9. An acute illness, including a body temperature greater than 100*F, within 3 days prior
             to immunization.

         10. Receipt of an experimental vaccine or medication within 1 month prior to enrollment in
             this study, or expectation of receiving an experimental vaccine, medication, or blood
             product during the study Stage in which the subject will participate.

         11. Developmental delay, neurologic disorder, or seizure disorder requiring ongoing
             medical management (note: history of seizure is not an exclusion criterion).

         12. Any other condition or situation that would, in the opinion of the investigator, place
             the potential subject an unacceptable risk of injury or render the subject unable to
             meet the requirements of the protocol.

         13. History of Guillain-Barré syndrome.

         14. Known pregnancy, positive urine or serum pregnancy test within 24 hours prior to
             planned study vaccination, or breast-feeding.

         15. Concurrent participation in another clinical trial (in active or follow-up phase).