This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
179
Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
Licensed and FDA approved FluAd vaccine to be administered to study participants
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17
Time frame: Year 1, Day 28 post vaccination
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17
Time frame: Year 1, Day 182 post vaccination
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17
Time frame: Year 1, Day 365 post vaccination
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18
Time frame: Year 2, Day 28 post vaccination
HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18
Time frame: Year 2, Day 182 post vaccination
HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17
Time frame: Year 1, Day 28 post vaccination
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Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17
Time frame: Year 1, Day 182 post vaccination
HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17
Time frame: Year 1, Day 365 post vaccination
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17
Time frame: Year 1, Day 28 post vaccination
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17
Time frame: Year 1, Day 182 post vaccination
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17
Time frame: Year 1, Day 365 post vaccination
MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination
Microneutralization antibody titers to vaccine virus (A/Hong Kong (siat cell) among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2017-18
Time frame: Year 2, Day 28 post vaccination
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 28 days post vaccination 2017-18
Time frame: Year 2, Day 28 post vaccination
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 182 days post vaccination 2017-18
Time frame: Year 2, Day 182 post vaccination
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination
Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 28 days after vaccination, 2017-18
Time frame: Year 2, Day 28 post vaccination
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination
Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 182 days after vaccination, 2017-18
Time frame: Year 2, Day 182 post vaccination
Number of Participants With Vaccine Failure, Year 1
Number of Participants with Vaccine Failure in Year 1 by vaccine type
Time frame: Year 1, Post season
Number of Participants With Vaccine Failure, Year 2
Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history
Time frame: Year 2, Post season