Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)

Phase 4

Completed

Conditions: Influenza

Interventions: Biological: Trivalent, inactivated influenza vaccine (TIV)
Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
Biological: Quadrivalent, inactivated influenza vaccine (IIV4)

Registration Number: NCT01827462

Lead Sponsor: Stanford University

Brief 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.

Detailed Description: Participants ranging in age from 18 to 100 at time of initial enrollment will be immunized annually with the seasonal influenza vaccine, Fluzone, on Day 0. Follow-up visits will be conducted on Day 6-8 and Day 28. Unsolicited adverse events are collected from immunization until the Day 28 visit, serious adverse events are collected for the entire time of study participation. A blood sample is collected pre-immunization and at each follow-up visit. Volunteers will be followed for up to 11 years, those too frail to come in for visits received annual phone calls to monitor health. Last annual influenza vaccines were given in Fall 2015.

The main basic research effort will be to collect safety data and follow medical history events in elderly and younger control subjects. Investigators will also look at immune responses to influenza vaccination. In 2008, 2012 and 2014, the cohort added additional participants to replace those who had withdrawn.

Beginning in 2014, those participants 65 years and older were immunized with High Dose trivalent Fluzone and younger participants received the quadrivalent formulation of Fluzone.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 136

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60-80 year olds at enrollment	Trivalent, inactivated influenza vaccine (TIV)	Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, High-Dose trivalent, inactivated influenza vaccine (TIV High-Dose) was given.
60-80 year olds at enrollment	High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)	Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, High-Dose trivalent, inactivated influenza vaccine (TIV High-Dose) was given.
18-30 year olds at enrollment	Quadrivalent, inactivated influenza vaccine (IIV4)	Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, Quadrivalent, inactivated influenza vaccine (IIV4) was given.
80-100 year olds at enrollment	Trivalent, inactivated influenza vaccine (TIV)	Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, High-Dose trivalent, inactivated influenza vaccine (TIV High-Dose) was given.
18-30 year olds at enrollment	Trivalent, inactivated influenza vaccine (TIV)	Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, Quadrivalent, inactivated influenza vaccine (IIV4) was given.
80-100 year olds at enrollment	High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)	Licensed seasonal Fluzone (inactivated influenza vaccine): Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season. Beginning with 2014-2015 season, High-Dose trivalent, inactivated influenza vaccine (TIV High-Dose) was given.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Received the Influenza Vaccine	Day 0 annually while on study

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Related Adverse Events	Day 0 to Day 28 following each annual vaccination while on study	Related adverse events were recorded annually during this 10 year longitudinal study.