Trial Outcomes & Findings for Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children (NCT NCT00391391)
NCT ID: NCT00391391
Last Updated: 2011-12-01
Results Overview
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
520 participants
Primary outcome timeframe
Day 0 and Day 28 post-vaccination
Results posted on
2011-12-01
Participant Flow
Study participants ere enrolled from 19 October to 12 December 2006 in 20 clinical centers in the US.
A total of 517 of the 520 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
97
|
161
|
164
|
|
Overall Study
COMPLETED
|
89
|
87
|
138
|
145
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
23
|
19
|
Reasons for withdrawal
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
7
|
4
|
|
Overall Study
Protocol Violation
|
2
|
3
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
10
|
7
|
Baseline Characteristics
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Baseline characteristics by cohort
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
n=97 Participants
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
n=97 Participants
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
n=160 Participants
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
n=163 Participants
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
Total
n=517 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
97 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
517 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 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
>=65 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 Continuous
|
22.6 Months
STANDARD_DEVIATION 7.51 • n=5 Participants
|
21.8 Months
STANDARD_DEVIATION 8.03 • n=7 Participants
|
69.6 Months
STANDARD_DEVIATION 22.2 • n=5 Participants
|
70.8 Months
STANDARD_DEVIATION 21.6 • n=4 Participants
|
46.5 Months
STANDARD_DEVIATION 14.835 • n=21 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
242 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
275 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
97 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
517 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post-vaccinationPopulation: Geometric Mean Titers were determined in the per-protocol population.
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Outcome measures
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
n=69 Participants
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
n=68 Participants
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
n=115 Participants
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
n=120 Participants
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Pre-vaccination
|
22.4 Titers
Interval 14.0 to 35.9
|
20.9 Titers
Interval 13.7 to 31.9
|
222.2 Titers
Interval 165.4 to 298.5
|
171.0 Titers
Interval 121.5 to 240.7
|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Pre-vaccination
|
8.9 Titers
Interval 7.1 to 11.2
|
9.6 Titers
Interval 7.5 to 12.3
|
20.5 Titers
Interval 15.6 to 26.9
|
26.9 Titers
Interval 19.6 to 37.1
|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Post-vaccination 2
|
31.1 Titers
Interval 23.7 to 40.8
|
18.2 Titers
Interval 13.9 to 24.0
|
56.4 Titers
Interval 43.8 to 72.7
|
51.6 Titers
Interval 40.8 to 65.2
|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Post-vaccination 1
|
58.5 Titers
Interval 28.6 to 119.4
|
113.1 Titers
Interval 59.9 to 213.7
|
100.1 Titers
Interval 55.0 to 182.1
|
264.2 Titers
Interval 162.8 to 428.9
|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Post-vaccination 2
|
138.3 Titers
Interval 105.2 to 181.8
|
160.0 Titers
Interval 123.7 to 206.9
|
162.9 Titers
Interval 128.7 to 206.3
|
390.6 Titers
Interval 308.2 to 495.0
|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Post-vaccination 1
|
341.8 Titers
Interval 142.9 to 817.7
|
566.9 Titers
Interval 304.6 to 1054.9
|
1012.5 Titers
Interval 666.9 to 1537.2
|
1256.9 Titers
Interval 898.2 to 1758.8
|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Post-vaccination 2
|
614.8 Titers
Interval 471.3 to 802.0
|
471.4 Titers
Interval 368.0 to 603.7
|
1111.0 Titers
Interval 944.0 to 1307.5
|
1344.4 Titers
Interval 1146.1 to 1577.1
|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Pre-vaccination
|
5.3 Titers
Interval 4.9 to 5.8
|
5.4 Titers
Interval 5.0 to 5.9
|
8.3 Titers
Interval 7.1 to 9.7
|
6.8 Titers
Interval 6.0 to 7.7
|
|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Post-vaccination 1
|
7.4 Titers
Interval 4.4 to 12.5
|
9.7 Titers
Interval 4.2 to 22.1
|
46.6 Titers
Interval 23.3 to 93.3
|
28.8 Titers
Interval 16.0 to 52.0
|
SECONDARY outcome
Timeframe: Day 28 post-vaccinationPopulation: 4-Fold Rise in Serum HAI Antibody Titers were determined in the per-protocol population
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Outcome measures
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
n=69 Participants
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
n=68 Participants
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
n=115 Participants
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
n=120 Participants
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Post-vaccination 2
|
91 Percentage of Participants
|
88 Percentage of Participants
Interval 0.0 to 0.0
|
70 Percentage of Participants
Interval 0.0 to 0.0
|
78 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Post-vaccination 1
|
81 Percentage of Participants
|
80 Percentage of Participants
Interval 0.0 to 0.0
|
44 Percentage of Participants
Interval 0.0 to 0.0
|
63 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Post-vaccination 1
|
52 Percentage of Participants
|
75 Percentage of Participants
Interval 0.0 to 0.0
|
65 Percentage of Participants
Interval 0.0 to 0.0
|
74 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Post-vaccination 2
|
44 Percentage of Participants
|
21 Percentage of Participants
Interval 0.0 to 0.0
|
55 Percentage of Participants
Interval 0.0 to 0.0
|
53 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Post-vaccination 2
|
88 Percentage of Participants
|
91 Percentage of Participants
Interval 0.0 to 0.0
|
50 Percentage of Participants
Interval 0.0 to 0.0
|
62 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Post-vaccination 1
|
5 Percentage of Participants
|
10 Percentage of Participants
Interval 0.0 to 0.0
|
44 Percentage of Participants
Interval 0.0 to 0.0
|
40 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Seroprotection to vaccine antigens were determined in the per-protocol population
Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Outcome measures
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
n=69 Participants
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
n=68 Participants
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
n=115 Participants
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
n=120 Participants
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Pre-vaccination
|
9 Percentage of Participants
|
12 Percentage of Participants
Interval 0.0 to 0.0
|
33 Percentage of Participants
Interval 0.0 to 0.0
|
40 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Pre-vaccination
|
32 Percentage of Participants
|
29 Percentage of Participants
Interval 0.0 to 0.0
|
86 Percentage of Participants
Interval 0.0 to 0.0
|
80 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Post-vaccination 1
|
85 Percentage of Participants
|
95 Percentage of Participants
Interval 0.0 to 0.0
|
97 Percentage of Participants
Interval 0.0 to 0.0
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Post-vaccination 2
|
44 Percentage of Participants
|
21 Percentage of Participants
Interval 0.0 to 0.0
|
63 Percentage of Participants
Interval 0.0 to 0.0
|
58 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Post-vaccination 1
|
52 Percentage of Participants
|
75 Percentage of Participants
Interval 0.0 to 0.0
|
79 Percentage of Participants
Interval 0.0 to 0.0
|
95 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Post-vaccination 2
|
91 Percentage of Participants
|
93 Percentage of Participants
Interval 0.0 to 0.0
|
92 Percentage of Participants
Interval 0.0 to 0.0
|
99 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Post-vaccination 2
|
100 Percentage of Participants
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
99 Percentage of Participants
Interval 0.0 to 0.0
|
100 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Pre-vaccination
|
2 Percentage of Participants
|
2 Percentage of Participants
Interval 0.0 to 0.0
|
9 Percentage of Participants
Interval 0.0 to 0.0
|
3 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Post-vaccination 1
|
5 Percentage of Participants
|
10 Percentage of Participants
Interval 0.0 to 0.0
|
47 Percentage of Participants
Interval 0.0 to 0.0
|
42 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Seroconversion to vaccine antigens were determined in the per-protocol population
Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer \< 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.
Outcome measures
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
n=69 Participants
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
n=97 Participants
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
n=160 Participants
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
n=120 Participants
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Post-vaccination 2
|
88 Percentage of Participants
|
91 Percentage of Participants
Interval 0.0 to 0.0
|
50 Percentage of Participants
Interval 0.0 to 0.0
|
62 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Post-vaccination 1
|
52 Percentage of Participants
|
75 Percentage of Participants
Interval 0.0 to 0.0
|
65 Percentage of Participants
Interval 0.0 to 0.0
|
74 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H1N1 Post-vaccination 2
|
91 Percentage of Participants
|
88 Percentage of Participants
Interval 0.0 to 0.0
|
70 Percentage of Participants
Interval 0.0 to 0.0
|
78 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup A/H3N2 Post-vaccination 1
|
81 Percentage of Participants
|
80 Percentage of Participants
Interval 0.0 to 0.0
|
44 Percentage of Participants
Interval 0.0 to 0.0
|
63 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Post-vaccination 1
|
5 Percentage of Participants
|
10 Percentage of Participants
Interval 0.0 to 0.0
|
44 Percentage of Participants
Interval 0.0 to 0.0
|
40 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Serogroup B Post-vaccination 2
|
44 Percentage of Participants
|
21 Percentage of Participants
Interval 0.0 to 0.0
|
55 Percentage of Participants
Interval 0.0 to 0.0
|
53 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 to Day 7 post-vaccinationPopulation: Safety parameters were determined post-vaccination in the safety, intend-to-treat population.
Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
Outcome measures
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
n=97 Participants
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
n=97 Participants
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Injection site induration Injection 2
|
18 Participants
|
14 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 Fever > 103.1°F
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Crying Abnormal Injection 1
|
17 Participants
|
29 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Irritability Injection 1
|
37 Participants
|
39 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 Crying Abnormal >3 hours
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any injection site tenderness Injection 1
|
51 Participants
|
43 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 Tenderness (Reduced movement)
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Injection site redness Injection 1
|
48 Participants
|
27 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 redness ( ≥ 5 cm)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Injection site swelling Injection 1
|
23 Participants
|
15 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 swelling ( ≥ 5 cm)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Injection site induration Injection 1
|
24 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 induration ( ≥ 5 cm)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Injection site ecchymosis Injection 1
|
12 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 ecchymosis ( ≥ 5 cm)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any injection site tenderness Injection 2
|
48 Participants
|
49 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Injection site redness Injection 2
|
48 Participants
|
28 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Injection site swelling Injection 2
|
18 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Injection site ecchymosis Injection 2
|
23 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Fever Injection 1
|
10 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Vomiting Injection 1
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 Vomiting ≥ 6 episodes per 24 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Drowsiness Injection 1
|
21 Participants
|
24 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 Drowsiness Sleeping most of the time
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Appetite Lost Injection 1
|
20 Participants
|
21 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 Appetite Lost refuses most feeds
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Grade 3 Irritability inconsolable
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Fever Injection 2
|
6 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Vomiting Injection 2
|
4 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Crying Abnormal Injection 2
|
19 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Drowsiness Injection 2
|
13 Participants
|
23 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Appetite Lost Injection 2
|
18 Participants
|
17 Participants
|
—
|
—
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Any Solicited Irritability Injection 2
|
30 Participants
|
30 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 7 post-vaccinationPopulation: Safety parameters were determined post-vaccination in the safety, intend-to-treat population.
Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
n=160 Participants
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
n=163 Participants
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Ecchymosis (≥ 5 cm)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Malaise Prevents daily activities
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any injection site Pain Injection 1
|
—
|
—
|
93 Participants
|
89 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Pain (Reduced movement)
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Injection site Redness Injection 1
|
—
|
—
|
98 Participants
|
42 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Redness ( ≥ 5 cm)
|
—
|
—
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Injection site Swelling Injection 1
|
—
|
—
|
59 Participants
|
30 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Swelling ( ≥ 5 cm)
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Injection site Induration Injection 1
|
—
|
—
|
56 Participants
|
25 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Fever > 102.2°F
|
—
|
—
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Induration ( ≥ 5 cm)
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Injection site Ecchymosis Injection 1
|
—
|
—
|
18 Participants
|
19 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Ecchymosis ( ≥ 5 cm)
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Pruritus Injection 1
|
—
|
—
|
23 Participants
|
11 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any injection site pain Injection 2
|
—
|
—
|
98 Participants
|
90 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Injection site Redness Injection 2
|
—
|
—
|
94 Participants
|
40 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Redness (≥ 5 cm)
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Injection site Swelling Injection 2
|
—
|
—
|
61 Participants
|
21 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 swelling ( ≥ 5 cm)
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Injection site Induration Injection 2
|
—
|
—
|
50 Participants
|
17 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Induration (≥ 5 cm)
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Injection site Ecchymosis Injection 2
|
—
|
—
|
18 Participants
|
22 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Pruritus Injection 2
|
—
|
—
|
15 Participants
|
19 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Fever Injection 1
|
—
|
—
|
10 Participants
|
18 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Headache Injection 1
|
—
|
—
|
22 Participants
|
25 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Headache Prevents daily activities
|
—
|
—
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Malaise Injection 1
|
—
|
—
|
21 Participants
|
30 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Myalgia Injection 1
|
—
|
—
|
24 Participants
|
42 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Grade 3 Myalgia Prevents daily activities
|
—
|
—
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Fever Injection 2
|
—
|
—
|
16 Participants
|
14 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Headache Injection 2
|
—
|
—
|
15 Participants
|
17 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Malaise Injection 2
|
—
|
—
|
24 Participants
|
21 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Any Solicited Myalgia Injection 2
|
—
|
—
|
24 Participants
|
25 Participants
|
Adverse Events
Group 1: Fluzone ID at Age 6 to 35 Months
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Group 2: Fluzone IM 6 to 35 Months Age Group
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Group 3: Fluzone ID at 3 to 8 Years Age
Serious events: 1 serious events
Other events: 98 other events
Deaths: 0 deaths
Group 4: Fluzone IM 3 to 8 Years Age
Serious events: 1 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
n=97 participants at risk
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
n=97 participants at risk
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
n=160 participants at risk
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
n=163 participants at risk
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
1.0%
1/97 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Viral infection
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.62%
1/160 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/97 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Nervous system disorders
Autism
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.61%
1/163 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
Other adverse events
| Measure |
Group 1: Fluzone ID at Age 6 to 35 Months
n=97 participants at risk
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
|
Group 2: Fluzone IM 6 to 35 Months Age Group
n=97 participants at risk
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
|
Group 3: Fluzone ID at 3 to 8 Years Age
n=160 participants at risk
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
|
Group 4: Fluzone IM 3 to 8 Years Age
n=163 participants at risk
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
5.2%
5/97 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
6.2%
6/97 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
7/97 • Number of events 8 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
9.3%
9/97 • Number of events 9 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
9.4%
15/160 • Number of events 15 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
1.8%
3/163 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Gastrointestinal disorders
Teething
|
7.2%
7/97 • Number of events 8 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
6.2%
6/97 • Number of events 11 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
5/93 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
8.1%
7/86 • Number of events 7 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Pyrexia
|
8.2%
8/97 • Number of events 9 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
22.7%
22/97 • Number of events 27 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
8.1%
13/160 • Number of events 13 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
8.6%
14/163 • Number of events 14 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Vessel puncture site bruise
|
11.3%
11/97 • Number of events 12 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
15.5%
15/97 • Number of events 17 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
6.9%
11/160 • Number of events 11 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
9.8%
16/163 • Number of events 19 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Bronchitis
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
5.2%
5/97 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Croup infections
|
4.1%
4/97 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
5.2%
5/97 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
2.5%
4/160 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
1.8%
3/163 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Gastroenteritis
|
5.2%
5/97 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
2.5%
4/160 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
1.2%
2/163 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Nasopharyngitis
|
14.4%
14/97 • Number of events 16 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
9.3%
9/97 • Number of events 11 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
2.5%
4/160 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
11.0%
18/163 • Number of events 20 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Otitis media
|
17.5%
17/97 • Number of events 19 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
23.7%
23/97 • Number of events 27 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
5.0%
8/160 • Number of events 9 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
4.9%
8/163 • Number of events 8 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Sinusitis
|
4.1%
4/97 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
7.2%
7/97 • Number of events 7 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
3.1%
5/160 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
2.5%
4/163 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Upper respiratory tract infection
|
15.5%
15/97 • Number of events 17 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
18.6%
18/97 • Number of events 23 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
5.6%
9/160 • Number of events 10 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
4.3%
7/163 • Number of events 10 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Infections and infestations
Viral infection
|
2.1%
2/97 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
5.2%
5/97 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
3.1%
5/160 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.0%
33/97 • Number of events 44 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
33.0%
32/97 • Number of events 39 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
28.7%
46/160 • Number of events 60 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
25.8%
42/163 • Number of events 55 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.2%
7/97 • Number of events 11 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
4.1%
4/97 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
2.5%
4/160 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
5.5%
9/163 • Number of events 11 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
2.1%
2/97 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
4.4%
7/160 • Number of events 8 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
7.4%
12/163 • Number of events 15 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
18.6%
18/97 • Number of events 24 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
19.6%
19/97 • Number of events 26 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
11.9%
19/160 • Number of events 30 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
12.3%
20/163 • Number of events 26 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Injection site Tenderness
|
54.8%
51/93 • Number of events 51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
56.3%
49/87 • Number of events 49 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
71.5%
98/137 • Number of events 98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
62.1%
90/145 • Number of events 90 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Injection site Redness
|
51.6%
48/93 • Number of events 48 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
32.2%
28/87 • Number of events 28 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
68.5%
98/143 • Number of events 98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
27.8%
42/151 • Number of events 42 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Injection site Swelling
|
26.1%
23/88 • Number of events 23 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
16.7%
15/90 • Number of events 15 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
44.5%
61/137 • Number of events 61 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
19.9%
30/151 • Number of events 30 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Injection site Induration
|
25.8%
24/93 • Number of events 24 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
16.1%
14/87 • Number of events 14 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
39.2%
56/143 • Number of events 56 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
16.6%
25/151 • Number of events 25 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Injection site Ecchymosis
|
26.1%
23/88 • Number of events 23 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
14.9%
13/87 • Number of events 13 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
12.6%
18/143 • Number of events 18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
15.2%
22/145 • Number of events 22 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Psychiatric disorders
Crying abnormal
|
18.3%
17/93 • Number of events 17 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
31.9%
29/91 • Number of events 29 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Nervous system disorders
Drowsiness
|
22.6%
21/93 • Number of events 21 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
26.4%
24/91 • Number of events 24 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Gastrointestinal disorders
Appetite lost
|
21.5%
20/93 • Number of events 20 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
23.1%
21/91 • Number of events 21 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Nervous system disorders
Irritability
|
39.8%
37/93 • Number of events 37 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
42.9%
39/91 • Number of events 39 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/160 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/163 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Malaise
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
17.6%
24/136 • Number of events 24 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
20.0%
30/150 • Number of events 30 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
General disorders
Myalgia
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
17.0%
24/141 • Number of events 24 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
28.0%
42/150 • Number of events 42 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
16.5%
23/139 • Number of events 23 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
13.2%
19/144 • Number of events 19 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
|
Nervous system disorders
Headache
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
0.00%
0/97 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
15.6%
22/141 • Number of events 22 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
16.7%
25/150 • Number of events 25 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
|
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