Trial Outcomes & Findings for Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults (NCT NCT02258334)
NCT ID: NCT02258334
Last Updated: 2015-10-19
Results Overview
Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
208 participants
Primary outcome timeframe
Day 0 up to Day 7 post-vaccination
Results posted on
2015-10-19
Participant Flow
Study participants were enrolled from 01 October 2014 to 07 November 2014 at 4 clinical sites in the United States.
A total of 208 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in this study.
Participant milestones
| Measure |
Group 1
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
54
|
52
|
52
|
|
Overall Study
COMPLETED
|
49
|
54
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults
Baseline characteristics by cohort
| Measure |
Group 1
n=50 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
n=54 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
n=52 Participants
Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
n=52 Participants
Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Age, Continuous
Age Continuous
|
44.8 Years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
48.0 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
73.9 Years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
72.2 Years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
59.8 Years
STANDARD_DEVIATION 16.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Outcome measures
| Measure |
Group 1
n=49 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
n=54 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection-site Pain
|
0.0 Percentage of participants
|
1.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection-site Erythema
|
6.1 Percentage of participants
|
35.2 Percentage of participants
|
3.8 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection site Erythema
|
0.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection-site Swelling
|
4.1 Percentage of participants
|
22.2 Percentage of participants
|
5.8 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection-site Swelling
|
0.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection-site Induration
|
6.1 Percentage of participants
|
18.5 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection-site Induration
|
0.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection-site Ecchymosis
|
0.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Fever
|
0.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Fever
|
0.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Headache
|
28.6 Percentage of participants
|
18.5 Percentage of participants
|
17.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Headache
|
0.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Malaise
|
16.3 Percentage of participants
|
27.8 Percentage of participants
|
9.6 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Malaise
|
0.0 Percentage of participants
|
1.9 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Myalgia
|
26.5 Percentage of participants
|
25.9 Percentage of participants
|
23.1 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Myalgia
|
0.0 Percentage of participants
|
1.9 Percentage of participants
|
1.9 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Shivering
|
4.1 Percentage of participants
|
9.3 Percentage of participants
|
1.9 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Shivering
|
0.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection-site Pain
|
53.1 Percentage of participants
|
51.9 Percentage of participants
|
36.5 Percentage of participants
|
40.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection-site Ecchymosis
|
2.0 Percentage of participants
|
5.6 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Geometric mean titers were assessed in the Per-Protocol Analysis Set.
Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
Outcome measures
| Measure |
Group 1
n=49 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
n=53 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
A/H1N1; Pre-vaccination (N=49,52,52,52)
|
153 Titers (1/dilution)
Interval 90.6 to 260.0
|
148 Titers (1/dilution)
Interval 94.3 to 231.0
|
148 Titers (1/dilution)
Interval 96.7 to 226.0
|
171 Titers (1/dilution)
Interval 124.0 to 237.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
A/H1N1; Post-vaccination (N=49,53,52,52)
|
707 Titers (1/dilution)
Interval 490.0 to 1020.0
|
632 Titers (1/dilution)
Interval 459.0 to 870.0
|
288 Titers (1/dilution)
Interval 200.0 to 414.0
|
386 Titers (1/dilution)
Interval 294.0 to 506.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
A/H3N2; Pre-vaccination (N=49,53,52,52)
|
139 Titers (1/dilution)
Interval 90.9 to 212.0
|
147 Titers (1/dilution)
Interval 97.6 to 221.0
|
168 Titers (1/dilution)
Interval 119.0 to 237.0
|
275 Titers (1/dilution)
Interval 193.0 to 390.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
A/H3N2; Post-vaccination (N=49,53,52,52)
|
613 Titers (1/dilution)
Interval 439.0 to 857.0
|
648 Titers (1/dilution)
Interval 470.0 to 894.0
|
349 Titers (1/dilution)
Interval 244.0 to 499.0
|
680 Titers (1/dilution)
Interval 490.0 to 942.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
B (Yamagata); Pre-vaccination (N=49,53,52,52)
|
596 Titers (1/dilution)
Interval 400.0 to 888.0
|
471 Titers (1/dilution)
Interval 324.0 to 684.0
|
471 Titers (1/dilution)
Interval 342.0 to 649.0
|
465 Titers (1/dilution)
Interval 340.0 to 635.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
B (Yamagata); Post-vaccination (N=49,53,52,52)
|
1836 Titers (1/dilution)
Interval 1376.0 to 2449.0
|
1272 Titers (1/dilution)
Interval 906.0 to 1785.0
|
864 Titers (1/dilution)
Interval 651.0 to 1146.0
|
994 Titers (1/dilution)
Interval 777.0 to 1270.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
B (Victoria); Pre-vaccination (N=49,0,52,0)
|
252 Titers (1/dilution)
Interval 164.0 to 385.0
|
NA Titers (1/dilution)
B (Victoria) antigen was not in the administered vaccine
|
273 Titers (1/dilution)
Interval 195.0 to 382.0
|
NA Titers (1/dilution)
B (Victoria) antigen was not in the administered vaccine
|
|
Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
B (Victoria); Post-vaccination (N=49,0,52,0)
|
1119 Titers (1/dilution)
Interval 838.0 to 1495.0
|
NA Titers (1/dilution)
B (Victoria) antigen was not in the administered vaccine
|
568 Titers (1/dilution)
Interval 430.0 to 750.0
|
NA Titers (1/dilution)
B (Victoria) antigen was not in the administered vaccine
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Seroprotection was assessed in the Per-Protocol Analysis Set.
Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution \[dil\]) at pre-vaccination and 21 days after vaccination.
Outcome measures
| Measure |
Group 1
n=49 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
n=53 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
B (Yamagata); Pre-vaccination (N=49,53,52,52)
|
98.0 Percentage of participants
|
98.1 Percentage of participants
|
96.2 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
B (Yamagata); Post-vaccination (N=49,53,52,52)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
A/H1N1; Pre-vaccination (N=49,52,52,52)
|
77.6 Percentage of participants
|
84.6 Percentage of participants
|
82.7 Percentage of participants
|
90.4 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
A/H1N1; Post-vaccination (N=49,53,52,52)
|
98.0 Percentage of participants
|
100.0 Percentage of participants
|
92.3 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
A/H3N2; Pre-vaccination (N=49,53,52,52)
|
81.6 Percentage of participants
|
83.0 Percentage of participants
|
90.4 Percentage of participants
|
96.2 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
A/H3N2; Post-vaccination (N=49,53,52,52)
|
98.0 Percentage of participants
|
100.0 Percentage of participants
|
94.2 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
B (Victoria); Pre-vaccination (n=49,0,52,0)
|
91.8 Percentage of participants
|
NA Percentage of participants
B (Victoria) antigen was not in the administered vaccine
|
94.2 Percentage of participants
|
NA Percentage of participants
B (Victoria) antigen was not in the administered vaccine
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
B (Victoria); Post-vaccination (N=49,0,52,0)
|
100.0 Percentage of participants
|
NA Percentage of participants
B (Victoria) antigen was not in the administered vaccine
|
100.0 Percentage of participants
|
NA Percentage of participants
B (Victoria) antigen was not in the administered vaccine
|
SECONDARY outcome
Timeframe: Day 21 post-vaccinationPopulation: Seroconversion was assessed in the Per-Protocol Analysis Set.
Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil) or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.
Outcome measures
| Measure |
Group 1
n=49 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
n=53 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H1N1 (N=49,52,52,52)
|
34.7 Percentage of participants
|
42.3 Percentage of participants
|
15.4 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H3N2 (N=49,53,52,52)
|
38.8 Percentage of participants
|
39.6 Percentage of participants
|
23.1 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (Yamagata) (N=49,53,52,52)
|
28.6 Percentage of participants
|
28.3 Percentage of participants
|
15.4 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (Victoria) (N=49,0,52,0)
|
51.0 Percentage of participants
|
NA Percentage of participants
B (Victoria) antigen was not in the administered vaccine
|
23.1 Percentage of participants
|
NA Percentage of participants
B (Victoria) antigen was not in the administered vaccine
|
SECONDARY outcome
Timeframe: Day 21 post-vaccinationPopulation: Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.
Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
Outcome measures
| Measure |
Group 1
n=49 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
n=53 Participants
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
n=52 Participants
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine
A/H1N1 (N=49,52,52,52)
|
4.32 Titer ratios
Interval 2.66 to 7.04
|
3.92 Titer ratios
Interval 2.54 to 6.06
|
1.91 Titer ratios
Interval 1.53 to 2.38
|
2.25 Titer ratios
Interval 1.79 to 2.83
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine
A/H3N2 (N=49,53,52,52)
|
4.26 Titer ratios
Interval 2.83 to 6.42
|
4.24 Titer ratios
Interval 2.93 to 6.14
|
2.08 Titer ratios
Interval 1.65 to 2.62
|
2.48 Titer ratios
Interval 1.97 to 3.12
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine
B (Yamagata) (N=49,53,52,52)
|
3.08 Titer ratios
Interval 2.21 to 4.29
|
2.70 Titer ratios
Interval 1.95 to 3.74
|
1.83 Titer ratios
Interval 1.48 to 2.28
|
2.14 Titer ratios
Interval 1.72 to 2.65
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine
B (Victoria) (N=49,0,52,0)
|
4.39 Titer ratios
Interval 3.05 to 6.3
|
NA Titer ratios
B (Victoria) antigen was not in the administered vaccine
|
2.08 Titer ratios
Interval 1.62 to 2.68
|
NA Titer ratios
B (Victoria) antigen was not in the administered vaccine
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Group 3
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=49 participants at risk
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
n=54 participants at risk
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
n=52 participants at risk
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
n=52 participants at risk
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/49 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
0.00%
0/54 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
Other adverse events
| Measure |
Group 1
n=49 participants at risk
Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 2
n=54 participants at risk
Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
|
Group 3
n=52 participants at risk
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
|
Group 4
n=52 participants at risk
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
|
|---|---|---|---|---|
|
General disorders
Injection site Pain
|
53.1%
26/49 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
51.9%
28/54 • Number of events 28 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
36.5%
19/52 • Number of events 19 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
40.4%
21/52 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
|
General disorders
Injection site Erythema
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
35.2%
19/54 • Number of events 19 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
7.7%
4/52 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
|
General disorders
Injection site Swelling
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
22.2%
12/54 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
5.8%
3/52 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
5.8%
3/52 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
|
General disorders
Injection site Induration
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
18.5%
10/54 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
|
General disorders
Injection site Ecchymosis
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
5.6%
3/54 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
|
Nervous system disorders
Headache
|
28.6%
14/49 • Number of events 14 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
18.5%
10/54 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
17.3%
9/52 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
25.0%
13/52 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
|
General disorders
Malaise
|
16.3%
8/49 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
27.8%
15/54 • Number of events 15 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
9.6%
5/52 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
15.4%
8/52 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.5%
13/49 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
25.9%
14/54 • Number of events 14 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
23.1%
12/52 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
28.8%
15/52 • Number of events 15 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
|
General disorders
Shivering
|
4.1%
2/49 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
9.3%
5/54 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER