Trial Outcomes & Findings for Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults. (NCT NCT01691339)
NCT ID: NCT01691339
Last Updated: 2013-11-04
Results Overview
Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - \>100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
Day 0 up to Day 7 post-vaccination
Results posted on
2013-11-04
Participant Flow
The study participants were enrolled from 19 through 27 September 2012 at 4 clinic centers in the United States.
A total of 200 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Participant milestones
| Measure |
Fluzone® Vaccine (Group 1)
Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® Intradermal Vaccine (Group 2)
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone® Vaccine (Group 3)
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® High-Dose Vaccine (Group 4)
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
51
|
49
|
|
Overall Study
COMPLETED
|
50
|
50
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.
Baseline characteristics by cohort
| Measure |
Fluzone® Vaccine (Group 1)
n=50 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® Intradermal Vaccine (Group 2)
n=50 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone® Vaccine (Group 3)
n=51 Participants
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® High-Dose Vaccine (Group 4)
n=49 Participants
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
Total
n=200 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
|
50 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Age Continuous
|
43.4 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
40.5 Years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
73.3 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
72.2 Years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
57.4 Years
STANDARD_DEVIATION 18.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
200 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - \>100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.
Outcome measures
| Measure |
Fluzone® Vaccine (Group 1)
n=50 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® Intradermal Vaccine (Group 2)
n=50 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone® Vaccine (Group 3)
n=51 Participants
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® High-Dose Vaccine (Group 4)
n=49 Participants
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Fever
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Headache
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Myalgia
|
10 Participants
|
10 Participants
|
13 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Shivering
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Shivering
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection site Pain
|
12 Participants
|
20 Participants
|
12 Participants
|
19 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection site Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection site Erythema
|
1 Participants
|
16 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection site Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection site Swelling
|
1 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection site Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection site Induration
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3Injection site Induration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Injection site Ecchymosis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Injection site Ecchymosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Headache
|
10 Participants
|
12 Participants
|
11 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Malaise
|
11 Participants
|
11 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Grade 3 Malaise
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) up to Day 21 post-vaccinationPopulation: Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.
Outcome measures
| Measure |
Fluzone® Vaccine (Group 1)
n=46 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® Intradermal Vaccine (Group 2)
n=47 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone® Vaccine (Group 3)
n=49 Participants
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® High-Dose Vaccine (Group 4)
n=46 Participants
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
|---|---|---|---|---|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)
|
28.3 Titers
Interval 17.5 to 45.6
|
30.7 Titers
Interval 18.3 to 51.7
|
58.6 Titers
Interval 37.5 to 91.6
|
81.8 Titers
Interval 50.2 to 133.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)
|
1068 Titers
Interval 755.0 to 1512.0
|
1473 Titers
Interval 955.0 to 2269.0
|
246 Titers
Interval 177.0 to 343.0
|
369 Titers
Interval 266.0 to 513.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46)
|
29.1 Titers
Interval 18.0 to 47.3
|
23.6 Titers
Interval 14.3 to 39.0
|
68.5 Titers
Interval 42.6 to 110.0
|
78.2 Titers
Interval 50.2 to 122.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)
|
460 Titers
Interval 306.0 to 691.0
|
599 Titers
Interval 369.0 to 971.0
|
264 Titers
Interval 176.0 to 397.0
|
392 Titers
Interval 266.0 to 578.0
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (Pre-vaccination; N = 46, 46, 49, 46)
|
17.9 Titers
Interval 13.0 to 24.6
|
20.9 Titers
Interval 15.5 to 28.3
|
13.7 Titers
Interval 10.5 to 17.7
|
18.7 Titers
Interval 14.4 to 24.3
|
|
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (Post-vaccination; N = 45, 47, 49, 46)
|
169 Titers
Interval 131.0 to 218.0
|
129 Titers
Interval 91.1 to 183.0
|
35.2 Titers
Interval 25.8 to 48.1
|
60.1 Titers
Interval 43.8 to 82.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).
Outcome measures
| Measure |
Fluzone® Vaccine (Group 1)
n=46 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® Intradermal Vaccine (Group 2)
n=47 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone® Vaccine (Group 3)
n=49 Participants
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® High-Dose Vaccine (Group 4)
n=46 Participants
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
|---|---|---|---|---|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)
|
22 Participants
Interval 32.9 to 63.1
|
23 Participants
Interval 34.9 to 65.1
|
32 Participants
Interval 50.4 to 78.3
|
33 Participants
Interval 56.5 to 84.0
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)
|
46 Participants
Interval 92.3 to 100.0
|
46 Participants
Interval 88.7 to 99.9
|
49 Participants
Interval 92.7 to 100.0
|
45 Participants
Interval 88.5 to 99.9
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46)
|
22 Participants
Interval 32.9 to 63.1
|
15 Participants
Interval 19.5 to 48.0
|
33 Participants
Interval 52.5 to 80.1
|
31 Participants
Interval 52.0 to 80.5
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)
|
44 Participants
Interval 88.2 to 99.9
|
45 Participants
Interval 85.5 to 99.5
|
46 Participants
Interval 83.1 to 98.7
|
45 Participants
Interval 88.5 to 99.9
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (Pre-vaccination; N = 46, 46, 49, 46)
|
9 Participants
Interval 9.4 to 33.9
|
15 Participants
Interval 19.5 to 48.0
|
8 Participants
Interval 7.3 to 29.7
|
13 Participants
Interval 16.0 to 43.5
|
|
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (Post-vaccination; N = 45, 47, 49, 46)
|
45 Participants
Interval 92.1 to 100.0
|
40 Participants
Interval 71.7 to 93.8
|
26 Participants
Interval 38.3 to 67.5
|
33 Participants
Interval 56.5 to 84.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.
Anti-influenza antibodies were measured using a 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.
Outcome measures
| Measure |
Fluzone® Vaccine (Group 1)
n=46 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® Intradermal Vaccine (Group 2)
n=47 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone® Vaccine (Group 3)
n=49 Participants
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® High-Dose Vaccine (Group 4)
n=46 Participants
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
|---|---|---|---|---|
|
Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H1N1 (N = 46, 46, 49, 46)
|
43 Participants
Interval 82.1 to 98.6
|
43 Participants
Interval 82.1 to 98.6
|
21 Participants
Interval 28.8 to 57.8
|
26 Participants
Interval 41.1 to 71.1
|
|
Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H3N2 (N = 45, 46, 49, 46)
|
34 Participants
Interval 60.5 to 87.1
|
39 Participants
Interval 71.1 to 93.7
|
19 Participants
Interval 25.2 to 53.8
|
28 Participants
Interval 45.4 to 74.9
|
|
Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (N = 45, 46, 49, 46)
|
36 Participants
Interval 65.4 to 90.4
|
33 Participants
Interval 56.5 to 84.0
|
13 Participants
Interval 14.9 to 41.1
|
16 Participants
Interval 21.4 to 50.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of \<1:10.
Outcome measures
| Measure |
Fluzone® Vaccine (Group 1)
n=46 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® Intradermal Vaccine (Group 2)
n=47 Participants
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone® Vaccine (Group 3)
n=49 Participants
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone® High-Dose Vaccine (Group 4)
n=46 Participants
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
|---|---|---|---|---|
|
Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)
|
0 Participants
Interval 0.0 to 7.9
|
1 Participants
Interval 0.1 to 11.3
|
0 Participants
Interval 0.0 to 7.3
|
0 Participants
Interval 0.0 to 7.7
|
|
Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)
|
18 Participants
Interval 25.1 to 54.6
|
17 Participants
Interval 23.2 to 52.5
|
6 Participants
Interval 4.6 to 24.8
|
6 Participants
Interval 4.9 to 26.3
|
|
Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)
|
0 Participants
Interval 0.0 to 7.7
|
1 Participants
Interval 0.1 to 11.3
|
0 Participants
Interval 0.0 to 7.3
|
0 Participants
Interval 0.0 to 7.7
|
|
Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
A/H3N2 (pre-vaccination; N = 46, 46, 49, 46)
|
17 Participants
Interval 23.2 to 52.5
|
19 Participants
Interval 27.0 to 56.8
|
6 Participants
Interval 4.6 to 24.8
|
2 Participants
Interval 0.5 to 14.8
|
|
Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (Pre-vaccination; N = 46, 46, 49, 46)
|
12 Participants
Interval 14.3 to 41.1
|
9 Participants
Interval 9.4 to 33.9
|
17 Participants
Interval 21.7 to 49.6
|
13 Participants
Interval 16.0 to 43.5
|
|
Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
B (Post-vaccination; N = 45, 47, 49, 46)
|
0 Participants
Interval 0.0 to 7.9
|
1 Participants
Interval 0.1 to 11.3
|
4 Participants
Interval 2.3 to 19.6
|
1 Participants
Interval 0.1 to 11.5
|
Adverse Events
Fluzone Vaccine (Group 1)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Fluzone Intradermal Vaccine (Group 2)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Fluzone Vaccine (Group 3)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Fluzone High-Dose Vaccine (Group 4)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone Vaccine (Group 1)
n=50 participants at risk
'Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly'
|
Fluzone Intradermal Vaccine (Group 2)
n=50 participants at risk
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone Vaccine (Group 3)
n=51 participants at risk
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone High-Dose Vaccine (Group 4)
n=49 participants at risk
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/49 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/50 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/49 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
Other adverse events
| Measure |
Fluzone Vaccine (Group 1)
n=50 participants at risk
'Adults 18 to \< 65 years of age received one dose of Fluzone vaccine intramuscularly'
|
Fluzone Intradermal Vaccine (Group 2)
n=50 participants at risk
Adults 18 to \< 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
|
Fluzone Vaccine (Group 3)
n=51 participants at risk
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
|
Fluzone High-Dose Vaccine (Group 4)
n=49 participants at risk
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
|
|---|---|---|---|---|
|
General disorders
Injection site Pain
|
24.0%
12/50 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
40.0%
20/50 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
23.5%
12/51 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
38.8%
19/49 • Number of events 19 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site Erythema
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
32.0%
16/50 • Number of events 16 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/51 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site Swelling
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
18.0%
9/50 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/51 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site Induration
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
8.0%
4/50 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/51 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Headache
|
20.0%
10/50 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
24.0%
12/50 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
21.6%
11/51 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
14.3%
7/49 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Malaise
|
22.0%
11/50 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
22.0%
11/50 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
19.6%
10/51 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
14.3%
7/49 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
10/50 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
20.0%
10/50 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
25.5%
13/51 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
14.3%
7/49 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Shivering
|
8.0%
4/50 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
8.0%
4/50 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
7.8%
4/51 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
6.1%
3/49 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 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