Trial Outcomes & Findings for Open-Label Influenza Vaccine Evaluation (NCT NCT02872311)

Results Overview

Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

179 participants

Primary outcome timeframe

Year 1, Day 365 post vaccination

Results posted on

2025-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	High Dose Influenza Vaccine This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants	Adjuvanted Influenza Vaccine This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	Standard+High Dose This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and high dose influenza vaccination (0.5mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants	Standard+Adjuvanted This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
Overall Study STARTED	59	60	20	20	20
Overall Study COMPLETED	55	58	19	20	20
Overall Study NOT COMPLETED	4	2	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dose Influenza Vaccine This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants	Adjuvanted Influenza Vaccine This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	Standard+High Dose This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and high dose influenza vaccination (0.5mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
Overall Study Death	2	0	0
Overall Study Lost to Follow-up	2	0	0
Overall Study Protocol Violation	0	2	1

Baseline Characteristics

Open-Label Influenza Vaccine Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=172 Participants Total of all reporting groups	High Dose Influenza Vaccine n=55 Participants This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	Standard Dose Influenza Vaccine+HD n=19 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants	Standard Dose Influenza Vaccine +Adj n=20 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants	Standard Dose Influenza Vaccine+Recomb n=20 Participants This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
Age, Continuous	70 years STANDARD_DEVIATION 2.6 • n=294 Participants	70 years STANDARD_DEVIATION 2.7 • n=4 Participants	69.6 years STANDARD_DEVIATION 2.6 • n=50 Participants	69.4 years STANDARD_DEVIATION 2.9 • n=681 Participants	69.2 years STANDARD_DEVIATION 2.2 • n=639 Participants	70 years STANDARD_DEVIATION 2.7 • n=277 Participants
Sex: Female, Male Female	90 Participants n=294 Participants	26 Participants n=4 Participants	33 Participants n=50 Participants	10 Participants n=681 Participants	12 Participants n=639 Participants	9 Participants n=277 Participants
Sex: Female, Male Male	82 Participants n=294 Participants	29 Participants n=4 Participants	25 Participants n=50 Participants	9 Participants n=681 Participants	8 Participants n=639 Participants	11 Participants n=277 Participants
Race/Ethnicity, Customized Race : White	172 Participants n=294 Participants	55 Participants n=4 Participants	58 Participants n=50 Participants	19 Participants n=681 Participants	20 Participants n=639 Participants	20 Participants n=277 Participants
Region of Enrollment United States	172 Participants n=294 Participants	55 Participants n=4 Participants	58 Participants n=50 Participants	19 Participants n=681 Participants	20 Participants n=639 Participants	20 Participants n=277 Participants

PRIMARY outcome

Timeframe: Year 1, Day 28 post vaccination

Population: This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.

Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination A/H1/California	117 Titer Interval 87.0 to 159.0	175 Titer Interval 128.0 to 239.0	—	—	—
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination A/H3/Hong Kong	118 Titer Interval 87.0 to 159.0	144 Titer Interval 102.0 to 201.0	—	—	—
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination B/Brisbane(Victoria)	81 Titer Interval 59.0 to 112.0	166 Titer Interval 117.0 to 236.0	—	—	—

PRIMARY outcome

Timeframe: Year 1, Day 182 post vaccination

Population: This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.

Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination A/H1/California	56 Titer Interval 41.0 to 77.0	83 Titer Interval 62.0 to 110.0	—	—	—
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination A/H3/Hong Kong	68 Titer Interval 51.0 to 91.0	83 Titer Interval 60.0 to 113.0	—	—	—
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination B/Brisbane(Victoria)	44 Titer Interval 33.0 to 60.0	61 Titer Interval 43.0 to 88.0	—	—	—

PRIMARY outcome

Timeframe: Year 1, Day 365 post vaccination

Population: This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.

Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination B/Brisbane(Victoria)	24 Titer Interval 17.0 to 32.0	36 Titer Interval 25.0 to 52.0	—	—	—
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination A/H1/California	44 Titer Interval 32.0 to 60.0	54 Titer Interval 40.0 to 72.0	—	—	—
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination A/H3/Hong Kong	75 Titer Interval 57.0 to 100.0	75 Titer Interval 55.0 to 103.0	—	—	—

PRIMARY outcome

Timeframe: Year 2, Day 28 post vaccination

Population: This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.

Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination A/H1/Michigan	101 Titer Interval 74.0 to 139.0	83 Titer Interval 64.0 to 107.0	—	—	—
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination A/H3/Hong Kong	158 Titer Interval 123.0 to 203.0	158 Titer Interval 114.0 to 220.0	—	—	—
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination B/Brisbane(Victoria)	45 Titer Interval 33.0 to 61.0	63 Titer Interval 46.0 to 87.0	—	—	—

PRIMARY outcome

Timeframe: Year 2, Day 182 post vaccination

Population: This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.

Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination A/H1/Michigan	44 Titer Interval 32.0 to 61.0	46 Titer Interval 35.0 to 61.0	—	—	—
HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination A/H3/Hong Kong	124 Titer Interval 93.0 to 165.0	101 Titer Interval 74.0 to 138.0	—	—	—
HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination B/Brisbane(Victoria)	30 Titer Interval 22.0 to 42.0	44 Titer Interval 31.0 to 61.0	—	—	—

SECONDARY outcome

Timeframe: Year 1, Day 28 post vaccination

Population: Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status.

Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=40 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=44 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ n=14 Participants 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD n=15 Participants 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination A/H1/California	136 Titer Interval 95.0 to 193.0	116 Titer Interval 82.0 to 165.0	122 Titer Interval 62.0 to 241.0	343 Titer Interval 194.0 to 608.0	—
HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination A/H3/Hong Kong	128 Titer Interval 85.0 to 193.0	105 Titer Interval 76.0 to 147.0	168 Titer Interval 82.0 to 343.0	197 Titer Interval 106.0 to 366.0	—
HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination B/Brisbane(Victoria)	142 Titer Interval 93.0 to 217.0	62 Titer Interval 45.0 to 84.0	195 Titer Interval 87.0 to 435.0	254 Titer Interval 136.0 to 475.0	—

SECONDARY outcome

Timeframe: Year 1, Day 182 post vaccination

Population: Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status.

Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=40 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=44 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ n=14 Participants 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD n=15 Participants 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination A/H1/California	67 Titer Interval 49.0 to 91.0	59 Titer Interval 41.0 to 85.0	48 Titer Interval 23.0 to 98.0	146 Titer Interval 81.0 to 264.0	—
HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination A/H3/Hong Kong	84 Titer Interval 56.0 to 126.0	68 Titer Interval 49.0 to 96.0	67 Titer Interval 35.0 to 128.0	78 Titer Interval 47.0 to 129.0	—
HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination B/Brisbane(Victoria)	51 Titer Interval 33.0 to 77.0	36 Titer Interval 27.0 to 48.0	86 Titer Interval 38.0 to 196.0	103 Titer Interval 52.0 to 202.0	—

SECONDARY outcome

Timeframe: Year 1, Day 365 post vaccination

Population: Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status.

Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=40 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=44 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ n=14 Participants 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD n=15 Participants 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination A/H1/California	48 Titer Interval 34.0 to 67.0	51 Titer Interval 36.0 to 74.0	26 Titer Interval 13.0 to 52.0	73 Titer Interval 39.0 to 137.0	—
HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination A/H3/Hong Kong	79 Titer Interval 53.0 to 117.0	82 Titer Interval 59.0 to 114.0	58 Titer Interval 31.0 to 107.0	66 Titer Interval 38.0 to 117.0	—
HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination B/Brisbane(Victoria)	34 Titer Interval 22.0 to 52.0	20 Titer Interval 15.0 to 28.0	38 Titer Interval 17.0 to 86.0	44 Titer Interval 20.0 to 96.0	—

SECONDARY outcome

Timeframe: Year 1, Day 28 post vaccination

Population: Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses.

Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination A/H3/Hong Kong 4801 (egg)	246 Titer Interval 160.0 to 380.0	256 Titer Interval 175.0 to 373.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination A/H3/Hong Kong 4801 (siat cell)	69 Titer Interval 49.0 to 96.0	57 Titer Interval 42.0 to 79.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination A/H3/NZ0783 (siat cell)	52 Titer Interval 37.0 to 71.0	47 Titer Interval 33.0 to 66.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination A/H3/OR19 (siat cell)	39 Titer Interval 27.0 to 56.0	32 Titer Interval 22.0 to 46.0	—	—	—

SECONDARY outcome

Timeframe: Year 1, Day 182 post vaccination

Population: Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses.

Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination A/H3/Hong Kong 4801 (egg)	132 Titer Interval 89.0 to 196.0	138 Titer Interval 91.0 to 208.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination A/H3/Hong Kong 4801 (siat cell)	42 Titer Interval 30.0 to 59.0	44 Titer Interval 33.0 to 60.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination A/H3/NZ0783 (siat cell)	30 Titer Interval 22.0 to 41.0	29 Titer Interval 22.0 to 40.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination A/H3/OR19 (siat cell)	25 Titer Interval 18.0 to 36.0	24 Titer Interval 18.0 to 33.0	—	—	—

SECONDARY outcome

Timeframe: Year 1, Day 365 post vaccination

Population: Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses.

Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination A/H3/Hong Kong 4801 (egg)	132 Titer Interval 89.0 to 196.0	138 Titer Interval 91.0 to 207.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination A/H3/Hong Kong 4801 (siat cell)	55 Titer Interval 51.0 to 74.0	45 Titer Interval 33.0 to 60.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination A/H3/NZ0783 (siat cell)	30 Titer Interval 22.0 to 41.0	29 Titer Interval 22.0 to 40.0	—	—	—
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination A/H3/OR19 (siat cell)	25 Titer Interval 18.0 to 36.0	24 Titer Interval 18.0 to 33.0	—	—	—

SECONDARY outcome

Timeframe: Year 2, Day 28 post vaccination

Population: Secondary objective examines response in adjuvant and high dose recipients to A/Hong Kong (siat cell) virus in year 2, 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

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination	95 Titer Interval 71.0 to 125.0	73 Titer Interval 55.0 to 96.0	—	—	—

SECONDARY outcome

Timeframe: Year 2, Day 28 post vaccination

Population: This secondary objective aimed to look at subjects receiving standard dose vaccine in the previous season and one of 3 licensed vaccines in the 2017-18 season.

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

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=19 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=20 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ n=20 Participants 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination A/H1/Michigan	86 Titer Interval 48.0 to 154.0	44 Titer Interval 24.0 to 81.0	126 Titer Interval 68.0 to 232.0	—	—
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination A/H3/Hong Kong	163 Titer Interval 84.0 to 317.0	126 Titer Interval 72.0 to 220.0	174 Titer Interval 97.0 to 313.0	—	—
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination B/Brisbane(Victoria)	83 Titer Interval 42.0 to 164.0	35 Titer Interval 21.0 to 57.0	53 Titer Interval 30.0 to 94.0	—	—

SECONDARY outcome

Timeframe: Year 2, Day 182 post vaccination

Population: This secondary objective aimed to look at subjects receiving standard dose vaccine in the previous season and one of 3 licensed vaccines in the 2017-18 season.

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

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=19 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=20 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ n=20 Participants 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination A/H1/Michigan	33 Titer Interval 17.0 to 66.0	26 Titer Interval 15.0 to 45.0	75 Titer Interval 41.0 to 135.0	—	—
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination A/H3/Hong Kong	122 Titer Interval 67.0 to 222.0	95 Titer Interval 55.0 to 164.0	135 Titer Interval 75.0 to 242.0	—	—
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination B/Brisbane(Victoria)	47 Titer Interval 26.0 to 86.0	26 Titer Interval 16.0 to 41.0	33 Titer Interval 19.0 to 58.0	—	—

SECONDARY outcome

Timeframe: Year 2, Day 28 post vaccination

Population: This secondary objective selects individuals receiving high dose or adjuvanted vaccine in year 2 of the study and compares immune response by vaccine received in the prior season.

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

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=55 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=58 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ n=20 Participants 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD n=19 Participants 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination A/H1/Michigan	83 Titer Interval 64.0 to 107.0	101 Titer Interval 74.0 to 139.0	44 Titer Interval 24.0 to 81.0	86 Titer Interval 48.0 to 154.0	—
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination A/H3/Hong Kong	158 Titer Interval 114.0 to 220.0	158 Titer Interval 123.0 to 203.0	126 Titer Interval 72.0 to 220.0	163 Titer Interval 84.0 to 317.0	—
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination B/Brisbane(Victoria)	63 Titer Interval 46.0 to 87.0	45 Titer Interval 33.0 to 61.0	35 Titer Interval 21.0 to 57.0	83 Titer Interval 42.0 to 164.0	—

SECONDARY outcome

Timeframe: Year 2, Day 182 post vaccination

Population: This secondary objective selects individuals receiving high dose or adjuvanted vaccine in year 2 of the study and compares immune response by vaccine received in the prior season.

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

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=55 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=58 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ n=20 Participants 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD n=19 Participants 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination A/H1/Michigan	46 Titer Interval 35.0 to 51.0	44 Titer Interval 32.0 to 61.0	26 Titer Interval 15.0 to 45.0	33 Titer Interval 17.0 to 66.0	—
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination A/H3/Hong Kong	101 Titer Interval 74.0 to 138.0	124 Titer Interval 93.0 to 165.0	95 Titer Interval 55.0 to 164.0	122 Titer Interval 67.0 to 222.0	—
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination B/Brisbane(Victoria)	44 Titer Interval 31.0 to 61.0	30 Titer Interval 22.0 to 42.0	26 Titer Interval 16.0 to 41.0	47 Titer Interval 26.0 to 86.0	—

SECONDARY outcome

Timeframe: Year 1, Post season

Population: Results of influenza surveillance after the first year examines individuals by the vaccine type received in Year 1.

Number of Participants with Vaccine Failure in Year 1 by vaccine type

Outcome measures

Outcome measures
Measure	Adjuvanted Influenza Vaccine n=58 Participants This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.	Standard Dose Influenza Vaccine +Adj n=55 Participants This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants	None-ADJ n=59 Participants 2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17	None-HD 2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17	Standard+Recombinant This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants
Number of Participants With Vaccine Failure, Year 1 H3 Positive	3 Participants	4 Participants	1 Participants	—	—
Number of Participants With Vaccine Failure, Year 1 B Positive	1 Participants	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Year 2, Post season

Population: Results of influenza surveillance after the second year examines individuals by groups based on the vaccine types received in both seasons.

Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history