Trial Outcomes & Findings for Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults (NCT NCT01946438)
NCT ID: NCT01946438
Last Updated: 2014-09-25
Results Overview
Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm; Fever, ≥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 21 post-vaccination
Results posted on
2014-09-25
Participant Flow
The study participants were enrolled from 16 to 24 September 2013 at 4 clinic centers in the United States.
A total of 208 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in the study.
Participant milestones
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
Participants age 18 to \< 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
Participants age 18 to \< 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
52
|
52
|
|
Overall Study
COMPLETED
|
50
|
52
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
Participants age 18 to \< 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
Participants age 18 to \< 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Serious Adverse event
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults
Baseline characteristics by cohort
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
n=52 Participants
Participants age 18 to \< 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
n=52 Participants
Participants age 18 to \< 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
n=52 Participants
Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)
n=52 Participants
Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
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
|
52 Participants
n=5 Participants
|
52 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
|
44.2 Years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
46.9 Years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
71.5 Years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
72.6 Years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
58.75 Years
STANDARD_DEVIATION 17.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
52 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 21 post-vaccinationPopulation: Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.
Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Outcome measures
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
n=52 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
n=52 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
n=52 Participants
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
n=52 Participants
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Injection-site induration (N = 51, 52, 52, 51)
|
1 Participants
|
4 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Injection-site ecchymosis (N= 51,52,52,51)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Malaise (N = 52, 52, 52, 52)
|
11 Participants
|
12 Participants
Interval 0.0 to 0.0
|
2 Participants
Interval 0.0 to 0.0
|
8 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Malaise (N = 52, 52, 52, 52)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Myalgia (N = 52, 52, 52, 51)
|
13 Participants
|
16 Participants
Interval 0.0 to 0.0
|
6 Participants
Interval 0.0 to 0.0
|
10 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Myalgia (N = 52, 52, 52, 51)
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Shivering (N = 52, 52, 52, 51)
|
3 Participants
|
2 Participants
Interval 0.0 to 0.0
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Shivering (N = 52, 52, 52, 51)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Injection-site erythema (N =52, 52,52, 51)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Injection-site pain (N = 52, 52, 52, 52)
|
27 Participants
|
30 Participants
Interval 0.0 to 0.0
|
10 Participants
Interval 0.0 to 0.0
|
21 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Injection-site pain (N = 52, 52, 52, 52)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Headache (N = 52, 52, 52, 51)
|
13 Participants
|
8 Participants
Interval 0.0 to 0.0
|
5 Participants
Interval 0.0 to 0.0
|
8 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Injection-site swelling (N = 51, 52, 52, 51)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Injection-site swelling (N = 51,52,52,51)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Injection-site induration (N= 51,52,52,51)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Injection-site ecchymosis (N = 51, 52, 52, 51)
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Fever (N = 52, 52, 52, 52)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Fever (N = 52, 52, 52, 52)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Injection-ste erythema (N=52,52,52,51)
|
0 Participants
|
15 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Grade 3 Headache (N = 52, 52, 52, 51)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 after vaccinationPopulation: Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the Per-Protocol Analysis Set.
Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
Outcome measures
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
n=49 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
n=52 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
n=51 Participants
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
n=51 Participants
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
B (Victoria; pre-vaccination)
|
24.7 Titers
Interval 17.6 to 34.7
|
NA Titers
B (Victoria) antigen was not in the vaccine administered to this group
|
34.2 Titers
Interval 25.8 to 45.5
|
NA Titers
B (Victoria) antigen was not in the vaccine administered to this group
|
|
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
A/H1N1 (pre-vaccination)
|
82.3 Titers
Interval 48.0 to 141.0
|
74.3 Titers
Interval 46.3 to 119.0
|
54.7 Titers
Interval 36.9 to 81.1
|
91.0 Titers
Interval 60.7 to 136.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
A/H1N1 (post-vaccination)
|
514 Titers
Interval 366.0 to 722.0
|
471 Titers
Interval 332.0 to 669.0
|
163 Titers
Interval 119.0 to 224.0
|
345 Titers
Interval 255.0 to 467.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
A/H3N2 (pre-vaccination)
|
77.2 Titers
Interval 45.2 to 132.0
|
128 Titers
Interval 81.2 to 203.0
|
185 Titers
Interval 128.0 to 267.0
|
104 Titers
Interval 67.7 to 159.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
A/H3N2 (post-vaccination)
|
563 Titers
Interval 399.0 to 796.0
|
531 Titers
Interval 396.0 to 712.0
|
449 Titers
Interval 344.0 to 587.0
|
636 Titers
Interval 464.0 to 871.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
B (Yamagata; pre-vaccination)
|
34.2 Titers
Interval 23.3 to 50.4
|
38.2 Titers
Interval 26.7 to 54.6
|
32.4 Titers
Interval 24.4 to 43.1
|
36.1 Titers
Interval 28.2 to 46.3
|
|
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
B (Yamagata; post-vaccination)
|
142 Titers
Interval 105.0 to 192.0
|
147 Titers
Interval 110.0 to 196.0
|
67.5 Titers
Interval 55.3 to 82.4
|
122 Titers
Interval 98.5 to 151.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
B (Victoria; post-vaccination)
|
134 Titers
Interval 96.6 to 186.0
|
NA Titers
B (Victoria) antigen was not in the vaccine administered to this group
|
67.5 Titers
Interval 52.7 to 86.4
|
NA Titers
B (Victoria) antigen was not in the vaccine administered to this group
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 after vaccinationPopulation: Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution).
Outcome measures
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
n=49 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
n=52 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
n=51 Participants
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
n=51 Participants
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
A/H1N1 (pre-vaccination)
|
34 Participants
|
36 Participants
Interval 0.0 to 0.0
|
32 Participants
Interval 0.0 to 0.0
|
39 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
A/H3N2 (post-vaccination)
|
48 Participants
|
52 Participants
Interval 0.0 to 0.0
|
50 Participants
Interval 0.0 to 0.0
|
51 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
B (Victoria; pre-vaccination)
|
23 Participants
|
NA Participants
Interval 0.0 to 0.0
B (Victoria) antigen was not in the vaccine administered to this group
|
32 Participants
Interval 0.0 to 0.0
|
NA Participants
Interval 0.0 to 0.0
B (Victoria) antigen was not in the vaccine administered to this group
|
|
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
B (Victoria; post-vaccination)
|
44 Participants
|
NA Participants
Interval 0.0 to 0.0
B (Victoria) antigen was not in the vaccine administered to this group
|
42 Participants
Interval 0.0 to 0.0
|
NA Participants
Interval 0.0 to 0.0
B (Victoria) antigen was not in the vaccine administered to this group
|
|
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
A/H1N1 (post-vaccination)
|
47 Participants
|
52 Participants
Interval 0.0 to 0.0
|
47 Participants
Interval 0.0 to 0.0
|
51 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
A/H3N2 (pre-vaccination)
|
33 Participants
|
41 Participants
Interval 0.0 to 0.0
|
47 Participants
Interval 0.0 to 0.0
|
41 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
B (Yamagata; pre-vaccination)
|
28 Participants
|
31 Participants
Interval 0.0 to 0.0
|
26 Participants
Interval 0.0 to 0.0
|
29 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
B (Yamagata; post-vaccination)
|
44 Participants
|
49 Participants
Interval 0.0 to 0.0
|
45 Participants
Interval 0.0 to 0.0
|
50 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 after vaccinationPopulation: Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Per-Protocol Analysis Set.
Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination.
Outcome measures
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
n=49 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
n=52 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
n=51 Participants
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
n=51 Participants
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
A/H1N1
|
23 Participants
|
26 Participants
Interval 0.0 to 0.0
|
17 Participants
Interval 0.0 to 0.0
|
25 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
A/H3N2
|
27 Participants
|
19 Participants
Interval 0.0 to 0.0
|
15 Participants
Interval 0.0 to 0.0
|
33 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
B (Yamagata)
|
19 Participants
|
18 Participants
Interval 0.0 to 0.0
|
5 Participants
Interval 0.0 to 0.0
|
21 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
B Victoria
|
25 Participants
|
NA Participants
Interval 0.0 to 0.0
B (Victoria) antigen was not in the vaccine administered to this group
|
9 Participants
Interval 0.0 to 0.0
|
NA Participants
Interval 0.0 to 0.0
B (Victoria) antigen was not in the vaccine administered to this group
|
SECONDARY outcome
Timeframe: Day 21 after vaccinationPopulation: Geometric mean titer ratios against each hemagglutinin antigen were assessed in the Per-Protocol Analysis Set.
Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines.
Outcome measures
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
n=49 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
n=52 Participants
Participants age 18 to \< 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
n=51 Participants
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
n=51 Participants
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine
A/H3N2
|
6.42 Titer Ratio
Interval 4.22 to 9.79
|
3.92 Titer Ratio
Interval 2.62 to 5.87
|
2.40 Titer Ratio
Interval 1.81 to 3.19
|
6.10 Titer Ratio
Interval 4.12 to 9.03
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine
A/H1N1
|
5.58 Titer Ratio
Interval 3.29 to 9.44
|
5.77 Titer Ratio
Interval 3.33 to 10.0
|
2.89 Titer Ratio
Interval 2.1 to 3.97
|
3.66 Titer Ratio
Interval 2.78 to 4.83
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine
B (Yamagata)
|
3.62 Titer Ratio
Interval 2.56 to 5.12
|
3.50 Titer Ratio
Interval 2.36 to 5.18
|
1.95 Titer Ratio
Interval 1.64 to 2.31
|
3.28 Titer Ratio
Interval 2.58 to 4.18
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine
B (Victoria)
|
4.74 Titer Ratio
Interval 3.23 to 6.95
|
NA Titer Ratio
B (Victoria) antigen was not in the vaccine administered to this group
|
1.86 Titer Ratio
Interval 1.55 to 2.22
|
NA Titer Ratio
B (Victoria) antigen was not in the vaccine administered to this group
|
Adverse Events
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
n=52 participants at risk
Participants age 18 to \< 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
n=52 participants at risk
Participants age 18 to \< 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
n=52 participants at risk
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
n=52 participants at risk
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
General disorders
Device failure
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
Other adverse events
| Measure |
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
n=52 participants at risk
Participants age 18 to \< 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
n=52 participants at risk
Participants age 18 to \< 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
|
Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
n=52 participants at risk
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
n=52 participants at risk
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
|
|---|---|---|---|---|
|
General disorders
Injection-site pain
|
51.9%
27/52 • Number of events 27 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
57.7%
30/52 • Number of events 30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
19.2%
10/52 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
40.4%
21/52 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
|
General disorders
Injection-site erythema
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
28.8%
15/52 • Number of events 15 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
|
General disorders
Injection-site induration
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
7.7%
4/52 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
0.00%
0/52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
0.00%
0/51 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
|
Nervous system disorders
Headache
|
25.0%
13/52 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
15.4%
8/52 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
9.6%
5/52 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
15.7%
8/51 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
|
General disorders
Malaise
|
21.2%
11/52 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
23.1%
12/52 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
15.4%
8/52 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
13/52 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
30.8%
16/52 • Number of events 16 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
11.5%
6/52 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
19.6%
10/51 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
|
General disorders
Shivering
|
5.8%
3/52 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
|
7.8%
4/51 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after 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