Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent, inactivated influenza vaccine (TIV); Quadrivalent, inactivated influenza vaccine (IIV4); High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
Intervention description: Licensed Seasonal Influenza Vaccine TIV; Licensed Seasonal Influenza Vaccine IIV4; Licensed Seasonal High-Dose Influenza Vaccine TIV
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inactivated, trivalent influenza vaccine; elderly; immunosenescence; longitudinal study; Inactivated, High-Dose trivalent influenza vaccine; Inactivated, quadrivalent influenza vaccine; young adults

Summary:

      In this study the investigators are trying to understand how immune function declines in the
      elderly using annual influenza vaccinations as a model system. The longitudinal study began
      in 2007 and continued through early 2017.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment

          -  General good health and ambulatory at time of enrollment

          -  No acute illness at time of vaccination

          -  Willing and able to sign Informed Consent

          -  Available for follow-up for the planned duration of the study

          -  Acceptable medical history by screening evaluation and brief clinical assessment

          -  All female subjects of childbearing potential must use an acceptable method of
             contraception and not become pregnant for the duration of the clinical phase of the
             study (approximately 1 month to completion of Visit 3). (Acceptable contraception may
             include implants, injectables, combined oral contraceptives, effective intrauterine
             devices (IUDs), sexual abstinence, or a vasectomized partner).

        Exclusion Criteria:

          -  Prior off-study vaccination with trivalent or quadrivalent (depending no year)
             influenza vaccine (TIV or IIV4) or live attenuated influenza vaccine (LAIV) in the
             current flu season

          -  Allergy to egg or egg products

          -  Allergy to vaccine components, including thimerosal

          -  Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          -  History of immunodeficiency

          -  Any chronic disorder which, in the opinion of the investigator, might jeopardize
             volunteer safety or compliance with the protocol.

          -  Blood pressure >150 systolic or > 95 diastolic at Visit 1

          -  Chronic Hepatitis B or C.

          -  Recent or current use of systemic immunosuppressive medication, including
             glucocorticoids (corticosteroid nasal sprays and inhaled steroids are permissible).
             Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review
             by the investigator.

          -  Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive
             medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion
             of the investigator, might jeopardize volunteer safety or compliance with the
             protocol.

          -  History of blood dyscrasias or hemoglobinopathies requiring regular medical follow up
             or hospitalization during the preceding year

          -  Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin, Plavix, Aggrenox must be reviewed by investigator to determine
             if this would affect the volunteer's safety.

          -  Receipt of blood or blood products within the past 6 months

          -  Medical or psychiatric condition or occupational responsibilities that preclude
             subject compliance with the protocol

          -  Receipt of inactivated vaccine within 14 days prior to vaccination

          -  Receipt of live, attenuated vaccine within 60 days of vaccination

          -  History of Guillain-Barré Syndrome

          -  Pregnant or lactating woman

          -  Use of investigational agents within 30 days prior to enrollment

          -  Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

          -  Any condition which, in the opinion of the investigator, might interfere with
             volunteer safety, study objectives or the ability of the participant to understand or
             comply with the study protocol.