Trial Outcomes & Findings for Influenza Vaccine Revaccination in Ambulatory Elderly Subjects (NCT NCT00775450)
NCT ID: NCT00775450
Last Updated: 2013-12-31
Results Overview
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
807 participants
Primary outcome timeframe
Days 0 through 7 post vaccination
Results posted on
2013-12-31
Participant Flow
Participants were enrolled from 14 October to 20 November 2008 in 27 medical centers in the US.
A total of 807 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Group 1a: Fluzone ID After Fluzone ID
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
295
|
98
|
105
|
108
|
201
|
|
Overall Study
COMPLETED
|
292
|
98
|
105
|
108
|
199
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Group 1a: Fluzone ID After Fluzone ID
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
|---|---|---|---|---|---|
|
Overall Study
Serious Adverse Event
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Baseline characteristics by cohort
| Measure |
Group 1a: Fluzone ID After Fluzone ID
n=295 Participants
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
n=98 Participants
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
n=105 Participants
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
n=108 Participants
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
n=201 Participants
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
Total
n=807 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
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 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
|
0 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
295 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
108 Participants
n=483 Participants
|
201 Participants
n=36 Participants
|
807 Participants
n=10 Participants
|
|
Age, Continuous
|
73.9 Years
STANDARD_DEVIATION 5.99 • n=93 Participants
|
74.2 Years
STANDARD_DEVIATION 5.97 • n=4 Participants
|
73.0 Years
STANDARD_DEVIATION 5.37 • n=27 Participants
|
74.3 Years
STANDARD_DEVIATION 5.11 • n=483 Participants
|
73.5 Years
STANDARD_DEVIATION 5.74 • n=36 Participants
|
73.8 Years
STANDARD_DEVIATION 5.74 • n=10 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
117 Participants
n=36 Participants
|
459 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
84 Participants
n=36 Participants
|
348 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
295 participants
n=93 Participants
|
98 participants
n=4 Participants
|
105 participants
n=27 Participants
|
108 participants
n=483 Participants
|
201 participants
n=36 Participants
|
807 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Days 0 through 7 post vaccinationPopulation: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
Outcome measures
| Measure |
Group 1a: Fluzone ID After Fluzone ID
n=292 Participants
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
n=98 Participants
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
n=105 Participants
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
n=107 Participants
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
n=200 Participants
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Fever
|
9 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Solicited Injection site Pain
|
68 Participants
|
18 Participants
|
23 Participants
|
31 Participants
|
91 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Pain (Incapacitating)
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Solicited Injection site Erythema
|
207 Participants
|
18 Participants
|
9 Participants
|
71 Participants
|
34 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Erythema (≥ 5 cm)
|
34 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Solicited Injection site Swelling
|
127 Participants
|
4 Participants
|
3 Participants
|
44 Participants
|
23 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Swelling (≥ 5 cm)
|
9 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Solicited Injection site Induration
|
133 Participants
|
6 Participants
|
6 Participants
|
50 Participants
|
18 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Induration (≥ 5 cm)
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Solicited Injection site Ecchymosis
|
27 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Ecchymosis (≥ 5 cm)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Solicited Injection site Pruritus
|
99 Participants
|
3 Participants
|
6 Participants
|
38 Participants
|
20 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Pruritus (Incapacitating)
|
6 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Fever (>102.2 ºF)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Headache
|
39 Participants
|
14 Participants
|
15 Participants
|
17 Participants
|
45 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Headache (Prevents daily activities)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Malaise
|
31 Participants
|
7 Participants
|
18 Participants
|
16 Participants
|
36 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Malaise (Prevents daily activities)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Myalgia
|
35 Participants
|
18 Participants
|
25 Participants
|
22 Participants
|
48 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Myalgia (Prevents daily activities)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Any Shivering
|
12 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Grade 3 Shivering (Prevents daily activities)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 post-vaccinationPopulation: Serum antibody titers were assessed in the per-protocol population.
Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.
Outcome measures
| Measure |
Group 1a: Fluzone ID After Fluzone ID
n=273 Participants
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
n=94 Participants
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
n=100 Participants
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
n=102 Participants
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
n=187 Participants
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186)
|
28.7 Titers
Interval 25.3 to 32.5
|
23.5 Titers
Interval 19.3 to 28.6
|
27.3 Titers
Interval 22.0 to 33.9
|
20.8 Titers
Interval 17.1 to 25.2
|
28.7 Titers
Interval 24.5 to 33.6
|
|
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185)
|
75.0 Titers
Interval 66.4 to 84.7
|
59.6 Titers
Interval 48.4 to 73.2
|
72.4 Titers
Interval 58.7 to 89.2
|
73.5 Titers
Interval 60.4 to 89.5
|
113 Titers
Interval 96.2 to 133.0
|
|
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186)
|
30.8 Titers
Interval 26.3 to 36.2
|
28.7 Titers
Interval 22.1 to 37.3
|
24.5 Titers
Interval 19.6 to 30.7
|
28.1 Titers
Interval 21.8 to 36.2
|
36.6 Titers
Interval 30.2 to 44.4
|
|
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
A/H2N3 Post Dose (n = 273, 94, 100, 102, 187)
|
244 Titers
Interval 205.0 to 289.0
|
212 Titers
Interval 156.0 to 288.0
|
257 Titers
Interval 197.0 to 336.0
|
273 Titers
Interval 208.0 to 358.0
|
454 Titers
Interval 380.0 to 543.0
|
|
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
B Pre Dose (n = 273, 94, 100, 102, 186
|
22.8 Titers
Interval 20.2 to 25.6
|
18.9 Titers
Interval 15.5 to 22.9
|
21.8 Titers
Interval 18.0 to 26.5
|
21.9 Titers
Interval 17.9 to 26.8
|
22.3 Titers
Interval 19.6 to 25.4
|
|
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
B Post Dose (n = 273, 94, 100, 102, 185)
|
54.3 Titers
Interval 48.3 to 61.0
|
51.4 Titers
Interval 42.4 to 62.3
|
60.4 Titers
Interval 49.6 to 73.6
|
51.1 Titers
Interval 42.9 to 60.9
|
78.2 Titers
Interval 68.5 to 89.3
|
SECONDARY outcome
Timeframe: Days 0 and 28 post-vaccinationPopulation: Serum antibody titers were assessed in the per-protocol population.
Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.
Outcome measures
| Measure |
Group 1a: Fluzone ID After Fluzone ID
n=273 Participants
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
n=94 Participants
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
n=100 Participants
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
n=102 Participants
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
n=187 Participants
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
A/H1N1 Serogroup - (Day 0, Pre-dose)
|
40 Percentage of Participants
|
36 Percentage of Participants
|
39 Percentage of Participants
|
26 Percentage of Participants
|
41 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
A/H1N1 Serogroup - (Day 28, Post-dose)
|
80 Percentage of Participants
|
72 Percentage of Participants
|
80 Percentage of Participants
|
81 Percentage of Participants
|
88 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
A/H3N2 Serogroup - (Day 0, Pre-dose)
|
49 Percentage of Participants
|
40 Percentage of Participants
|
38 Percentage of Participants
|
48 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
A/H3N2 Serogroup - (Day 28, Post-dose)
|
93 Percentage of Participants
|
86 Percentage of Participants
|
94 Percentage of Participants
|
91 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
B Serogroup - (Day 0, Pre-dose)
|
36 Percentage of Participants
|
29 Percentage of Participants
|
32 Percentage of Participants
|
32 Percentage of Participants
|
36 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
B Serogroup - (Day 28, Post-dose)
|
73 Percentage of Participants
|
69 Percentage of Participants
|
75 Percentage of Participants
|
66 Percentage of Participants
|
83 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 28 post vaccinationPopulation: Serum antibody titers were assessed in the per-protocol population.
Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.
Outcome measures
| Measure |
Group 1a: Fluzone ID After Fluzone ID
n=273 Participants
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
n=94 Participants
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
n=100 Participants
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
n=102 Participants
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
n=186 Participants
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
A/H1N1 (N = 273, 94, 100, 102, 185)
|
31 Percentage of Participants
|
28 Percentage of Participants
|
31 Percentage of Participants
|
44 Percentage of Participants
|
47 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
A/H2N3 (N = 273, 94, 100, 102, 186)
|
73 Percentage of Participants
|
64 Percentage of Participants
|
76 Percentage of Participants
|
75 Percentage of Participants
|
84 Percentage of Participants
|
|
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
B (N = 273, 94, 100, 102, 185)
|
24 Percentage of Participants
|
31 Percentage of Participants
|
33 Percentage of Participants
|
26 Percentage of Participants
|
41 Percentage of Participants
|
Adverse Events
Group 1a: Fluzone ID After Fluzone ID
Serious events: 10 serious events
Other events: 239 other events
Deaths: 0 deaths
Group 1b: Fluzone IM After Fluzone ID
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Group 2a: Fluzone IM After Fluzone IM
Serious events: 6 serious events
Other events: 54 other events
Deaths: 0 deaths
Group 2b: Fluzone ID After Fluzone IM
Serious events: 3 serious events
Other events: 86 other events
Deaths: 0 deaths
Group 3: Fluzone HD After Fluzone HD
Serious events: 10 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1a: Fluzone ID After Fluzone ID
n=292 participants at risk；n=295 participants at risk
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
n=98 participants at risk
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
n=105 participants at risk
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
n=107 participants at risk；n=108 participants at risk
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
n=200 participants at risk；n=201 participants at risk
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
2.9%
3/105 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
1.0%
1/98 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.95%
1/105 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Gastrointestinal disorders
Umbilical Hernia, Obstructive
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
General disorders
Chest Pain
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.95%
1/105 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
General disorders
Non Cardiac Chest Pain
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.95%
1/105 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.93%
1/108 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Infections and infestations
Bronchitis
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Infections and infestations
Bacterial Sepsis
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
1.0%
1/98 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Infections and infestations
Infective Exacerbation of Chronic Obstructive Airways Disease
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Infections and infestations
Otitis Media Chronic
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Infections and infestations
Pneumonia
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.93%
1/108 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.95%
1/105 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.93%
1/108 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
1.0%
1/98 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Nervous system disorders
Cerebral Cyst
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.95%
1/105 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Hepatobiliary disorders
Cholecystectomy
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
1.0%
1/98 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Vascular disorders
Haemorrhage
|
0.34%
1/295 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Vascular disorders
Hypertension
|
0.00%
0/295 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/105 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.00%
0/108 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
0.50%
1/201 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
Other adverse events
| Measure |
Group 1a: Fluzone ID After Fluzone ID
n=292 participants at risk；n=295 participants at risk
Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
|
Group 1b: Fluzone IM After Fluzone ID
n=98 participants at risk
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
|
Group 2a: Fluzone IM After Fluzone IM
n=105 participants at risk
Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
|
Group 2b: Fluzone ID After Fluzone IM
n=107 participants at risk；n=108 participants at risk
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
|
Group 3: Fluzone HD After Fluzone HD
n=200 participants at risk；n=201 participants at risk
Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
|
|---|---|---|---|---|---|
|
General disorders
Injection Site Pain
|
23.3%
68/292 • Number of events 68 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
18.4%
18/98 • Number of events 18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
21.9%
23/105 • Number of events 23 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
29.0%
31/107 • Number of events 31 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
45.5%
91/200 • Number of events 91 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
General disorders
Injection Site Erythema
|
70.9%
207/292 • Number of events 207 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
18.4%
18/98 • Number of events 18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
8.6%
9/105 • Number of events 9 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
66.4%
71/107 • Number of events 71 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
17.0%
34/200 • Number of events 34 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
General disorders
Injection Site Swelling
|
43.5%
127/292 • Number of events 127 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
4.1%
4/98 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
2.9%
3/105 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
41.1%
44/107 • Number of events 44 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
11.5%
23/200 • Number of events 23 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
General disorders
Injection Site Induration
|
45.5%
133/292 • Number of events 133 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
6.1%
6/98 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
5.7%
6/105 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
46.7%
50/107 • Number of events 50 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
9.0%
18/200 • Number of events 18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Vascular disorders
Injection Site Ecchymosis
|
9.2%
27/292 • Number of events 27 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
2.0%
2/98 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
4.8%
5/105 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
10.3%
11/107 • Number of events 11 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
3.0%
6/200 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Skin and subcutaneous tissue disorders
Injection Site Pruritus
|
33.9%
99/292 • Number of events 99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
3.1%
3/98 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
5.7%
6/105 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
35.5%
38/107 • Number of events 38 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
10.0%
20/200 • Number of events 20 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
General disorders
Malaise
|
10.6%
31/292 • Number of events 31 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
7.1%
7/98 • Number of events 7 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
17.1%
18/105 • Number of events 18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
15.0%
16/107 • Number of events 16 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
18.0%
36/200 • Number of events 36 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
General disorders
Shivering
|
4.1%
12/292 • Number of events 12 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
2.0%
2/98 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
4.8%
5/105 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
6.5%
7/107 • Number of events 7 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
4.5%
9/200 • Number of events 9 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
35/292 • Number of events 35 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
18.4%
18/98 • Number of events 18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
23.8%
25/105 • Number of events 25 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
20.6%
22/107 • Number of events 22 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
24.0%
48/200 • Number of events 48 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
|
Nervous system disorders
Headache
|
13.4%
39/292 • Number of events 39 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
14.3%
14/98 • Number of events 14 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
14.3%
15/105 • Number of events 15 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
15.9%
17/107 • Number of events 17 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
|
22.5%
45/200 • Number of events 45 • Adverse events data were collected from the day of vaccination to up to 6 months 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