Trial Outcomes & Findings for Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults (NCT NCT02563093)
NCT ID: NCT02563093
Last Updated: 2016-12-12
Results Overview
Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
208 participants
Primary outcome timeframe
Day 0 up to Day 7 post-vaccination
Results posted on
2016-12-12
Participant Flow
Study participants were enrolled from 28 September 2015 to 03 November 2015 at 4 clinic centers in the United States.
A total of 208 participants who met all of the inclusion criteria and no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine (≥ 65 Years)
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
53
|
51
|
|
Overall Study
COMPLETED
|
52
|
52
|
53
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults
Baseline characteristics by cohort
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
n=52 Participants
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine
n=52 Participants
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
n=53 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine
n=51 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
104 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
104 Participants
n=36 Participants
|
|
Age, Continuous
|
46.4 Years
STANDARD_DEVIATION 13.5 • n=93 Participants
|
43.4 Years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
72.8 Years
STANDARD_DEVIATION 5.2 • n=27 Participants
|
74.2 Years
STANDARD_DEVIATION 6.2 • n=483 Participants
|
59.2 Years
STANDARD_DEVIATION 17.9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
130 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
78 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
208 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: The vaccine safety outcomes were assessed in the Safety Analysis Set. A participant (18 to \< 65 Years) who was assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) group in the Safety Analysis Set.
Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
n=53 Participants
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
n=51 Participants
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
n=53 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine (≥ 65 Years)
n=51 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
|---|---|---|---|---|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Injection-site Pain (N=53, 51, 53, 51)
|
29 Participants
|
29 Participants
|
15 Participants
|
22 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Injection-site Pain (N=53, 51, 53, 51)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Injection-site Erythema (N=53, 51, 53, 51)
|
1 Participants
|
17 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Injection-site Erythema (N=53, 51, 53, 51)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Injection-site Swelling (N=53, 51, 53, 51)
|
1 Participants
|
10 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Injection-site Swelling (N=53, 51, 53, 51)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Injection-site Induration (N=53, 51, 53, 51)
|
1 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Injection-site Induration (N=53,51,53,51)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Injection-site Ecchymosis (N=53, 51, 53, 51)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Injection-site Ecchymosis (N=53,51,53,51)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Fever (N=52, 51, 53, 51)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Fever (N=52, 51, 53, 51)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Headache (N=53, 51, 53, 51)
|
13 Participants
|
12 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Headache (N=53, 51, 53, 51)
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Malaise (N=53, 51, 53, 51)
|
7 Participants
|
11 Participants
|
10 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Malaise (N=53, 51, 53, 51)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Myalgia (N=53, 51, 53, 51)
|
15 Participants
|
11 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Myalgia (N=53, 51, 53, 51)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Shivering (N=53, 51, 53, 51)
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Grade 3 Shivering (N=53, 51, 53, 51)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and 21 days post-vaccinationPopulation: Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
Anti-influenza antibodies were measured using an hemagglutination inhibition assay.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
n=51 Participants
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
n=50 Participants
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
n=53 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine (≥ 65 Years)
n=51 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
|---|---|---|---|---|
|
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H1N1; Pre-vaccination (N=51,50,53,51)
|
274 Titers (1/dilutions)
Interval 173.0 to 433.0
|
196 Titers (1/dilutions)
Interval 134.0 to 286.0
|
160 Titers (1/dilutions)
Interval 109.0 to 234.0
|
62.2 Titers (1/dilutions)
Interval 44.4 to 87.3
|
|
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H1N1; Post-vaccination (N=51,50,53,51)
|
764 Titers (1/dilutions)
Interval 564.0 to 1034.0
|
631 Titers (1/dilutions)
Interval 435.0 to 915.0
|
283 Titers (1/dilutions)
Interval 196.0 to 407.0
|
324 Titers (1/dilutions)
Interval 242.0 to 435.0
|
|
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H3N2; Pre-vaccination (N=51,50,53,51)
|
49.4 Titers (1/dilutions)
Interval 32.0 to 76.2
|
61.9 Titers (1/dilutions)
Interval 44.4 to 86.3
|
48.0 Titers (1/dilutions)
Interval 34.4 to 67.0
|
50.1 Titers (1/dilutions)
Interval 36.4 to 68.7
|
|
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H3N2; Post-vaccination (N=51,50,53,51)
|
1051 Titers (1/dilutions)
Interval 687.0 to 1609.0
|
1033 Titers (1/dilutions)
Interval 717.0 to 1488.0
|
379 Titers (1/dilutions)
Interval 248.0 to 580.0
|
769 Titers (1/dilutions)
Interval 517.0 to 1143.0
|
|
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Yamagata; Pre-vaccination (N=51,50,53,51)
|
186 Titers (1/dilutions)
Interval 118.0 to 293.0
|
307 Titers (1/dilutions)
Interval 208.0 to 454.0
|
208 Titers (1/dilutions)
Interval 147.0 to 293.0
|
134 Titers (1/dilutions)
Interval 101.0 to 179.0
|
|
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Yamagata; Post-vaccination (N=51,50,53,51)
|
881 Titers (1/dilutions)
Interval 581.0 to 1336.0
|
1099 Titers (1/dilutions)
Interval 822.0 to 1469.0
|
438 Titers (1/dilutions)
Interval 311.0 to 617.0
|
471 Titers (1/dilutions)
Interval 352.0 to 632.0
|
|
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Victoria; Pre-vaccination (N=51,50,53,0)
|
234 Titers (1/dilutions)
Interval 161.0 to 340.0
|
290 Titers (1/dilutions)
Interval 213.0 to 397.0
|
178 Titers (1/dilutions)
Interval 122.0 to 258.0
|
NA Titers (1/dilutions)
B Victoria Influenza antigen not in administered vaccine for this group
|
|
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Victoria; Post-vaccination (N=51,50,53,0)
|
1237 Titers (1/dilutions)
Interval 901.0 to 1700.0
|
844 Titers (1/dilutions)
Interval 621.0 to 1149.0
|
355 Titers (1/dilutions)
Interval 260.0 to 485.0
|
NA Titers (1/dilutions)
B Victoria Influenza antigen not in administered vaccine for this group
|
SECONDARY outcome
Timeframe: Day 0 (Pre-vaccination) and 21 days post-vaccinationPopulation: Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
n=51 Participants
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
n=50 Participants
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
n=53 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine (≥ 65 Years)
n=51 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
|---|---|---|---|---|
|
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H1N1; Pre-vaccination (N=51,50,53,51)
|
45 Participants
|
47 Participants
|
47 Participants
|
38 Participants
|
|
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H1N1; Post-vaccination (N=51,50,53,51)
|
51 Participants
|
50 Participants
|
50 Participants
|
50 Participants
|
|
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H3N2; Pre-vaccination (N=51,50,53,51)
|
32 Participants
|
35 Participants
|
36 Participants
|
28 Participants
|
|
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H3N2; Post vaccination (N=51,50,53,51)
|
50 Participants
|
50 Participants
|
50 Participants
|
51 Participants
|
|
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Yamagata; Pre-vaccination (N=51,50,53,51)
|
41 Participants
|
48 Participants
|
51 Participants
|
48 Participants
|
|
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Yamagata; Post-vaccination (N=51,50,53,51)
|
51 Participants
|
50 Participants
|
53 Participants
|
51 Participants
|
|
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Victoria; Pre-vaccination (N=51,50,53,0)
|
47 Participants
|
49 Participants
|
49 Participants
|
NA Participants
B Victoria Influenza antigen not in administered vaccine for this group
|
|
Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Victoria; Post-vaccination (N=51,50,53,0)
|
51 Participants
|
49 Participants
|
53 Participants
|
NA Participants
B Victoria Influenza antigen not in administered vaccine for this group
|
SECONDARY outcome
Timeframe: 21 days post-vaccinationPopulation: Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
n=51 Participants
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
n=50 Participants
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
n=53 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine (≥ 65 Years)
n=51 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
|---|---|---|---|---|
|
Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H1N1 (N=51,50,53,51)
|
15 Participants
|
17 Participants
|
9 Participants
|
27 Participants
|
|
Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H3N2 (N=51,50,53,51)
|
44 Participants
|
42 Participants
|
35 Participants
|
44 Participants
|
|
Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Yamagata (N=51,50,53,51)
|
29 Participants
|
24 Participants
|
13 Participants
|
23 Participants
|
|
Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Victoria (N=51,50,53,0)
|
27 Participants
|
15 Participants
|
9 Participants
|
NA Participants
B Victoria Influenza antigen not in administered vaccine for this group
|
SECONDARY outcome
Timeframe: 21 days post-vaccinationPopulation: Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
Anti-influenza antibodies were measured using an hemagglutination inhibition assay.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
n=51 Participants
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
n=50 Participants
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
n=53 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine (≥ 65 Years)
n=51 Participants
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H1N1 (N=51,50,53,51)
|
2.72 Titer ratio
Interval 1.92 to 3.84
|
3.18 Titer ratio
Interval 2.25 to 4.49
|
1.77 Titer ratio
Interval 1.38 to 2.26
|
5.07 Titer ratio
Interval 3.5 to 7.35
|
|
Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
A/H3N2 (N=51,50,53,51)
|
19.4 Titer ratio
Interval 12.5 to 29.9
|
16.4 Titer ratio
Interval 10.4 to 26.1
|
7.49 Titer ratio
Interval 4.97 to 11.3
|
15.2 Titer ratio
Interval 10.2 to 22.5
|
|
Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Yamagata (N=51,50,53,51)
|
4.74 Titer ratio
Interval 3.22 to 6.98
|
3.58 Titer ratio
Interval 2.52 to 5.09
|
2.11 Titer ratio
Interval 1.6 to 2.78
|
3.52 Titer ratio
Interval 2.59 to 4.76
|
|
Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
B Victoria (N=51,50,53,0)
|
5.29 Titer ratio
Interval 3.54 to 7.89
|
2.87 Titer ratio
Interval 2.15 to 3.83
|
1.97 Titer ratio
Interval 1.52 to 2.57
|
NA Titer ratio
B Victoria Influenza antigen not in administered vaccine for this group
|
Adverse Events
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Fluzone Quadrivalent Vaccine (≥ 65 Years)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Fluzone High-Dose Vaccine (≥ 65 Years)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
n=53 participants at risk
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
n=51 participants at risk
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
n=53 participants at risk
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine (≥ 65 Years)
n=51 participants at risk
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/51 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/51 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/51 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
Other adverse events
| Measure |
Fluzone Quadrivalent Vaccine (18 to < 65 Years)
n=53 participants at risk
Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)
n=51 participants at risk
Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
|
Fluzone Quadrivalent Vaccine (≥ 65 Years)
n=53 participants at risk
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
|
Fluzone High-Dose Vaccine (≥ 65 Years)
n=51 participants at risk
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
|
|---|---|---|---|---|
|
General disorders
Injection site Pruritus
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
7.8%
4/51 • Number of events 4 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/51 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
General disorders
Injection site Pain
|
54.7%
29/53 • Number of events 29 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
56.9%
29/51 • Number of events 29 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
28.3%
15/53 • Number of events 15 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
43.1%
22/51 • Number of events 22 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
General disorders
Injection site Erythema
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
33.3%
17/51 • Number of events 17 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
13.7%
7/51 • Number of events 7 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
General disorders
Injection site Swelling
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
19.6%
10/51 • Number of events 10 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
5.9%
3/51 • Number of events 3 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
General disorders
Injection site Induration
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
11.8%
6/51 • Number of events 6 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/53 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
24.5%
13/53 • Number of events 13 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
23.5%
12/51 • Number of events 12 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
17.0%
9/53 • Number of events 9 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
11.8%
6/51 • Number of events 6 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
General disorders
Malaise
|
13.2%
7/53 • Number of events 7 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
21.6%
11/51 • Number of events 11 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
18.9%
10/53 • Number of events 10 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
11.8%
6/51 • Number of events 6 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.3%
15/53 • Number of events 15 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
21.6%
11/51 • Number of events 11 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
17.0%
9/53 • Number of events 9 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
25.5%
13/51 • Number of events 13 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
|
General disorders
Shivering
|
11.3%
6/53 • Number of events 6 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/51 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
0.00%
0/51 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
|
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