Trial Outcomes & Findings for Open-Label Influenza Vaccine Evaluation (NCT NCT02872311)
NCT ID: NCT02872311
Last Updated: 2019-12-19
Results Overview
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
179 participants
Primary outcome timeframe
Year 1, Day 28 post vaccination
Results posted on
2019-12-19
Participant Flow
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
| 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
Death
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Open-Label Influenza Vaccine Evaluation
Baseline characteristics by cohort
| Measure |
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
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
69.4 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
69.2 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
70 years
STANDARD_DEVIATION 2.7 • n=21 Participants
|
70 years
STANDARD_DEVIATION 2.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
90 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
82 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
172 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
172 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Year 1, Day 28 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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
|
175 Titer
Interval 128.0 to 239.0
|
117 Titer
Interval 87.0 to 159.0
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination
A/H3/Hong Kong
|
144 Titer
Interval 102.0 to 201.0
|
118 Titer
Interval 87.0 to 159.0
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination
B/Brisbane(Victoria)
|
166 Titer
Interval 117.0 to 236.0
|
81 Titer
Interval 59.0 to 112.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 1, Day 182 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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
|
83 Titer
Interval 62.0 to 110.0
|
56 Titer
Interval 41.0 to 77.0
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination
A/H3/Hong Kong
|
83 Titer
Interval 60.0 to 113.0
|
68 Titer
Interval 51.0 to 91.0
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination
B/Brisbane(Victoria)
|
61 Titer
Interval 43.0 to 88.0
|
44 Titer
Interval 33.0 to 60.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 1, Day 365 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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
A/H1/California
|
54 Titer
Interval 40.0 to 72.0
|
44 Titer
Interval 32.0 to 60.0
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination
A/H3/Hong Kong
|
75 Titer
Interval 55.0 to 103.0
|
75 Titer
Interval 57.0 to 100.0
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination
B/Brisbane(Victoria)
|
36 Titer
Interval 25.0 to 52.0
|
24 Titer
Interval 17.0 to 32.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 2, Day 28 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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
|
83 Titer
Interval 64.0 to 107.0
|
101 Titer
Interval 74.0 to 139.0
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 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
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination
B/Brisbane(Victoria)
|
63 Titer
Interval 46.0 to 87.0
|
45 Titer
Interval 33.0 to 61.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 2, Day 182 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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
|
46 Titer
Interval 35.0 to 61.0
|
44 Titer
Interval 32.0 to 61.0
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 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
|
—
|
—
|
—
|
|
HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination
B/Brisbane(Victoria)
|
44 Titer
Interval 31.0 to 61.0
|
30 Titer
Interval 22.0 to 42.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1, Day 28 post vaccinationPopulation: 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
| Measure |
High Dose Influenza Vaccine
n=44 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.
|
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.
|
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
|
116 Titer
Interval 82.0 to 165.0
|
136 Titer
Interval 95.0 to 193.0
|
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
|
105 Titer
Interval 76.0 to 147.0
|
128 Titer
Interval 85.0 to 193.0
|
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)
|
62 Titer
Interval 45.0 to 84.0
|
142 Titer
Interval 93.0 to 217.0
|
195 Titer
Interval 87.0 to 435.0
|
254 Titer
Interval 136.0 to 475.0
|
—
|
SECONDARY outcome
Timeframe: Year 1, Day 182 post vaccinationPopulation: 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
| Measure |
High Dose Influenza Vaccine
n=44 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.
|
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.
|
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
|
59 Titer
Interval 41.0 to 85.0
|
67 Titer
Interval 49.0 to 91.0
|
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
|
68 Titer
Interval 49.0 to 96.0
|
84 Titer
Interval 56.0 to 126.0
|
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)
|
36 Titer
Interval 27.0 to 48.0
|
51 Titer
Interval 33.0 to 77.0
|
86 Titer
Interval 38.0 to 196.0
|
103 Titer
Interval 52.0 to 202.0
|
—
|
SECONDARY outcome
Timeframe: Year 1, Day 365 post vaccinationPopulation: 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
| Measure |
High Dose Influenza Vaccine
n=44 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.
|
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.
|
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
|
51 Titer
Interval 36.0 to 74.0
|
48 Titer
Interval 34.0 to 67.0
|
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
|
82 Titer
Interval 59.0 to 114.0
|
79 Titer
Interval 53.0 to 117.0
|
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)
|
20 Titer
Interval 15.0 to 28.0
|
34 Titer
Interval 22.0 to 52.0
|
38 Titer
Interval 17.0 to 86.0
|
44 Titer
Interval 20.0 to 96.0
|
—
|
SECONDARY outcome
Timeframe: Year 1, Day 28 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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)
|
256 Titer
Interval 175.0 to 373.0
|
246 Titer
Interval 160.0 to 380.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination
A/H3/Hong Kong 4801 (siat cell)
|
57 Titer
Interval 42.0 to 79.0
|
69 Titer
Interval 49.0 to 96.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination
A/H3/NZ0783 (siat cell)
|
47 Titer
Interval 33.0 to 66.0
|
52 Titer
Interval 37.0 to 71.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination
A/H3/OR19 (siat cell)
|
32 Titer
Interval 22.0 to 46.0
|
39 Titer
Interval 27.0 to 56.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1, Day 182 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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)
|
138 Titer
Interval 91.0 to 208.0
|
132 Titer
Interval 89.0 to 196.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination
A/H3/Hong Kong 4801 (siat cell)
|
44 Titer
Interval 33.0 to 60.0
|
42 Titer
Interval 30.0 to 59.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination
A/H3/NZ0783 (siat cell)
|
29 Titer
Interval 22.0 to 40.0
|
30 Titer
Interval 22.0 to 41.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination
A/H3/OR19 (siat cell)
|
24 Titer
Interval 18.0 to 33.0
|
25 Titer
Interval 18.0 to 36.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1, Day 365 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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)
|
138 Titer
Interval 91.0 to 207.0
|
132 Titer
Interval 89.0 to 196.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination
A/H3/Hong Kong 4801 (siat cell)
|
45 Titer
Interval 33.0 to 60.0
|
55 Titer
Interval 51.0 to 74.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination
A/H3/NZ0783 (siat cell)
|
29 Titer
Interval 22.0 to 40.0
|
30 Titer
Interval 22.0 to 41.0
|
—
|
—
|
—
|
|
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination
A/H3/OR19 (siat cell)
|
24 Titer
Interval 18.0 to 33.0
|
25 Titer
Interval 18.0 to 36.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 2, Day 28 post vaccinationPopulation: 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
| Measure |
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.
|
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.
|
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
|
73 Titer
Interval 55.0 to 96.0
|
95 Titer
Interval 71.0 to 125.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 2, Day 28 post vaccinationPopulation: 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
| Measure |
High Dose Influenza Vaccine
n=20 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.
|
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.
|
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
|
44 Titer
Interval 24.0 to 81.0
|
86 Titer
Interval 48.0 to 154.0
|
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
|
126 Titer
Interval 72.0 to 220.0
|
163 Titer
Interval 84.0 to 317.0
|
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)
|
35 Titer
Interval 21.0 to 57.0
|
83 Titer
Interval 42.0 to 164.0
|
53 Titer
Interval 30.0 to 94.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 2, Day 182 post vaccinationPopulation: 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
| Measure |
High Dose Influenza Vaccine
n=20 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.
|
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.
|
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
|
26 Titer
Interval 15.0 to 45.0
|
33 Titer
Interval 17.0 to 66.0
|
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
|
95 Titer
Interval 55.0 to 164.0
|
122 Titer
Interval 67.0 to 222.0
|
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)
|
26 Titer
Interval 16.0 to 41.0
|
47 Titer
Interval 26.0 to 86.0
|
33 Titer
Interval 19.0 to 58.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 2, Day 28 post vaccinationPopulation: 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
| Measure |
High Dose Influenza Vaccine
n=58 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.
|
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.
|
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
|
101 Titer
Interval 74.0 to 139.0
|
83 Titer
Interval 64.0 to 107.0
|
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 123.0 to 203.0
|
158 Titer
Interval 114.0 to 220.0
|
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)
|
45 Titer
Interval 33.0 to 61.0
|
63 Titer
Interval 46.0 to 87.0
|
35 Titer
Interval 21.0 to 57.0
|
83 Titer
Interval 42.0 to 164.0
|
—
|
SECONDARY outcome
Timeframe: Year 2, Day 182 post vaccinationPopulation: 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
| Measure |
High Dose Influenza Vaccine
n=58 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.
|
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.
|
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
|
44 Titer
Interval 32.0 to 61.0
|
46 Titer
Interval 35.0 to 51.0
|
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
|
124 Titer
Interval 93.0 to 165.0
|
101 Titer
Interval 74.0 to 138.0
|
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)
|
30 Titer
Interval 22.0 to 42.0
|
44 Titer
Interval 31.0 to 61.0
|
26 Titer
Interval 16.0 to 41.0
|
47 Titer
Interval 26.0 to 86.0
|
—
|
SECONDARY outcome
Timeframe: Year 1, Post seasonPopulation: 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
| Measure |
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.
|
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.
|
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
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Vaccine Failure, Year 1
B Positive
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 2, Post seasonPopulation: 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
Outcome measures
| Measure |
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.
|
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.
|
None-ADJ
n=19 Participants
2015-16 Unvaccinated individual who received adjuvanted vaccine in the study in 2016-17
|
None-HD
n=20 Participants
2015-16 Unvaccinated individual who received high dose vaccine in the study in 2016-17
|
Standard+Recombinant
n=20 Participants
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 2
B positive
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vaccine Failure, Year 2
H3 positive
|
3 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
High Dose Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Adjuvanted Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Dose Influenza Vaccine+HD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Dose Influenza Vaccine +Adj
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Dose Influenza Vaccine+Recomb
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place