Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response
Condition: Influenza A Subtype H5N1 Infection
MeSH terms: Influenza, Human
Intervention: Seasonal Influenza Vaccine; Seasonal Influenza Vaccine
Intervention description: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study; A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Exploratory study with up to 50 subjects total, who previously participated in the HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immune response

Summary:

      The study is a prospective single site exploratory study to examine the impact of Food and
      Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1
      vaccine previously received with or without the AS03 adjuvant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent
             Vaccine with and without AS03 Adjuvant study.

          -  Capable of informed consent and provision of written informed consent before any study
             procedures.

          -  Capable of attending all study visits according to the study schedule.

          -  Are in good health, as determined by medical history and targeted physical exam
             related to this history.

          -  Female subjects of childbearing age must have a negative urine pregnancy test before
             study vaccination, and must use at least one form of contraception to avoid pregnancy
             for 28 days before and 28 days after Fluarix Quadrivalent administration.

        Exclusion Criteria:

          -  Have an acute illness, including any fever (> 100.4 F [> 38 degrees C], regardless of
             the route) within 72 hours before vaccination.

          -  Have any acute or chronic medical condition that, in the opinion of the principal
             investigator, would make vaccination unsafe or interfere with the evaluation of immune
             response to study vaccination.

          -  Alcohol or drug abuse and psychiatric conditions that, in the opinion of the
             investigator, would preclude compliance with the trial or interpretation of safety or
             endpoint data.

          -  Have a suppressed immune system as a result of illness, immunosuppressive medication,
             chemotherapy, or radiation therapy within 3 years prior to study vaccination.

          -  Are pregnant or breastfeeding or plan to within one month of vaccination.

          -  Have taken oral or parenteral corticosteroids of any dose within 28 days before study
             vaccination.

          -  Have a known history of autoimmune disease.

          -  Have a history of Guillain-Barre Syndrome.

          -  Have a history of bleeding disorders.

          -  Have known hypersensitivity or allergy to any component of the vaccine, including egg
             and latex allergies, or history of anaphylaxis with influenza vaccine or vaccine
             component.

          -  Have received blood or blood products 3 months prior to study entry or expected to
             receive through 6 months after study entry.

          -  Have received any live virus vaccines within 4 weeks prior to study entry or expected
             receipt within 4 weeks after study entry.

          -  Have received any inactivated vaccine within 2 weeks or expected receipt within 2
             weeks after study entry.

          -  Have received any experimental agents within 6 weeks prior to study or plan to through
             study duration.

          -  Have received the 2018-2019 influenza seasonal vaccine.

          -  Documented influenza infection during the 2018-2019 influenza season.

          -  Social, occupational, or any other condition that in the opinion of the investigator
             might interfere with compliance with the study and vaccine evaluation.