Trial Outcomes & Findings for A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population (NCT NCT00959049)
NCT ID: NCT00959049
Last Updated: 2017-05-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1474 participants
Primary outcome timeframe
30 days after the last study vaccination
Results posted on
2017-05-16
Participant Flow
Participants were enrolled into this study during the autumn of 2009 at 23 sites in the US.
A total of 1474 participants were enrolled, vaccinated and analyzed.
Participant milestones
| Measure |
Afluria Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort B
Age 3 to \< 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort C
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
231
|
254
|
254
|
228
|
257
|
250
|
|
Overall Study
COMPLETED
|
213
|
247
|
253
|
217
|
248
|
249
|
|
Overall Study
NOT COMPLETED
|
18
|
7
|
1
|
11
|
9
|
1
|
Reasons for withdrawal
| Measure |
Afluria Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort B
Age 3 to \< 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort C
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
17
|
5
|
1
|
10
|
9
|
1
|
|
Overall Study
Contraindicated medication
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
Baseline characteristics by cohort
| Measure |
Afluria Cohort A
n=231 Participants
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort B
n=254 Participants
Age 3 to \< 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort C
n=254 Participants
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
n=228 Participants
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
n=257 Participants
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
n=250 Participants
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Total
n=1474 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
231 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
257 Participants
n=21 Participants
|
250 Participants
n=10 Participants
|
1474 Participants
n=115 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
1.94 years
STANDARD_DEVIATION 0.667 • n=5 Participants
|
5.93 years
STANDARD_DEVIATION 1.725 • n=7 Participants
|
12.98 years
STANDARD_DEVIATION 2.388 • n=5 Participants
|
1.96 years
STANDARD_DEVIATION 0.673 • n=4 Participants
|
5.82 years
STANDARD_DEVIATION 1.748 • n=21 Participants
|
12.86 years
STANDARD_DEVIATION 2.474 • n=10 Participants
|
7.06 years
STANDARD_DEVIATION 4.855 • n=115 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
120 Participants
n=10 Participants
|
728 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
130 Participants
n=10 Participants
|
746 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
231 participants
n=5 Participants
|
254 participants
n=7 Participants
|
254 participants
n=5 Participants
|
228 participants
n=4 Participants
|
257 participants
n=21 Participants
|
250 participants
n=10 Participants
|
1474 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 30 days after the last study vaccinationPopulation: Per-protocol population
Outcome measures
| Measure |
Afluria Cohort A
n=195 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=229 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
n=230 Participants
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
n=201 Participants
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
n=236 Participants
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
n=233 Participants
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer 30 Days After the Last Study Vaccination
B (B/Brisbane/60/2008)
|
73.46 Titers
Interval 59.32 to 90.97
|
122.71 Titers
Interval 102.55 to 146.83
|
107.92 Titers
Interval 71.77 to 126.91
|
57.92 Titers
Interval 46.92 to 71.49
|
104.91 Titers
Interval 88.67 to 123.42
|
126.99 Titers
Interval 107.53 to 149.97
|
|
Geometric Mean Titer 30 Days After the Last Study Vaccination
H1N1 (A/Brisbane/59/2007)
|
235.44 Titers
Interval 199.67 to 277.61
|
345.50 Titers
Interval 295.54 to 403.92
|
652.99 Titers
Interval 566.91 to 752.14
|
227.19 Titers
Interval 188.39 to 273.98
|
351.88 Titers
Interval 303.29 to 408.25
|
652.17 Titers
Interval 569.59 to 746.73
|
|
Geometric Mean Titer 30 Days After the Last Study Vaccination
H3N2 ( A/Uruguay/716/2007)
|
309.19 Titers
Interval 253.49 to 377.13
|
909.22 Titers
Interval 772.67 to 1069.9
|
948.86 Titers
Interval 824.88 to 1091.46
|
340.49 Titers
Interval 283.98 to 408.25
|
870.34 Titers
Interval 751.62 to 1007.8
|
1069.7 Titers
Interval 934.77 to 1224.11
|
PRIMARY outcome
Timeframe: 30 days after the last study vaccinationPopulation: Per-Protocol Population
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Outcome measures
| Measure |
Afluria Cohort A
n=195 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=229 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
n=230 Participants
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
n=201 Participants
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
n=236 Participants
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
n=233 Participants
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
H1N1 (A/Brisbane/59/2007)
|
84 Percentage of participants
Interval 78.0 to 89.0
|
66 Percentage of participants
Interval 59.0 to 72.0
|
64 Percentage of participants
Interval 57.0 to 70.0
|
74 Percentage of participants
Interval 67.0 to 80.0
|
64 Percentage of participants
Interval 58.0 to 70.0
|
61 Percentage of participants
Interval 55.0 to 68.0
|
|
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
H3N2 ( A/Uruguay/716/2007)
|
83 Percentage of participants
Interval 77.0 to 88.0
|
71 Percentage of participants
Interval 65.0 to 77.0
|
72 Percentage of participants
Interval 66.0 to 78.0
|
85 Percentage of participants
Interval 79.0 to 90.0
|
74 Percentage of participants
Interval 68.0 to 80.0
|
73 Percentage of participants
Interval 66.0 to 78.0
|
|
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
B (B/Brisbane/60/2008)
|
67 Percentage of participants
Interval 60.0 to 73.0
|
73 Percentage of participants
Interval 67.0 to 79.0
|
67 Percentage of participants
Interval 31.0 to 73.0
|
61 Percentage of participants
Interval 54.0 to 68.0
|
76 Percentage of participants
Interval 70.0 to 82.0
|
73 Percentage of participants
Interval 67.0 to 79.0
|
SECONDARY outcome
Timeframe: 7 days after each vaccinationPopulation: Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110
Outcome measures
| Measure |
Afluria Cohort A
n=229 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=228 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 pain (post dose 1)
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 swelling (> 30 mm) (post dose 1)
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any local solicited symptom post-dose 2
|
30 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any local solicited symptom post-dose 1
|
116 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any pain (post dose 1)
|
98 Participants
|
78 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any redness (> 0 mm) (post dose 1)
|
53 Participants
|
53 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 redness (> 30 mm) (post dose 1)
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any swelling (> 0 mm) (post dose 1)
|
30 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any pain (post dose 2)
|
28 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 pain (post dose 2)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any redness (> 0 mm) (post dose 2)
|
15 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 redness (> 30 mm) (post dose 2)
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any swelling (> 0 mm) (post dose 2)
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 swelling (> 30 mm) (post dose 2)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any systemic solicited symptom, post dose 1
|
171 Participants
|
121 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose1
|
85 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 fever > 103.1°F ax or> 104.0°F oral, dose1
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any nausea/vomiting, dose 1
|
27 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 nausea/vomiting prevented activities,dose1
|
22 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any diarrhea, dose 1
|
61 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 diarrhea prevented activities, dose 1
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any loss of appetite, dose 1
|
73 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade3 loss of appetite prevented activities dose1
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any irritability, dose 1
|
134 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 irritability prevented activities dose 1
|
10 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any systemic solicited symptom post-dose 2
|
48 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose 2
|
14 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 fever > 103.1°F ax or> 104.0°F oral, dose2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any nausea/vomiting, dose 2
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade3 nausea/vomiting prevented activities, dose2
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any diarrhea, dose 2
|
17 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade3 diarrhea (prevented activities), dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any loss of appetite, dose 2
|
15 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade3 loss of appetite prevented activities dose2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any irritability, dose 2
|
38 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Grade 3 irritability prevented activities, dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days after each vaccinationPopulation: Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78
Outcome measures
| Measure |
Afluria Cohort A
n=252 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=255 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any local solicited symptom post-dose 1
|
164 Participants
|
152 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any pain, post dose 1
|
149 Participants
|
131 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any swelling (> 0 mm), post dose 1
|
36 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 swelling (> 30 mm), post dose 1
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any diarrhea, dose 1
|
17 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any headache, dose 2
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 pain, post dose 1
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any redness (> 0 mm), post dose 1
|
59 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 redness (> 30 mm), post dose 1
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any local solicited symptom post-dose 2
|
24 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any pain, post dose 2
|
23 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 pain, post dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any redness (> 0 mm), post dose 2
|
5 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 redness (> 30 mm), post dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any swelling (> 0 mm), post dose 2
|
4 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 swelling (> 30 mm), post dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any systemic solicited symptom post-dose 1
|
140 Participants
|
113 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any fever ≥ 99.5°F ax or ≥ 100.4°F oral, dose 1
|
55 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 fever > 103.1°F ax or > 104.0°F oral dose1
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any nausea/vomiting, dose 1
|
33 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade3 nausea/vomiting prevented activities, dose1
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 diarrhea (prevented activities), dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any malaise, dose 1
|
72 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 malaise (prevented activities), dose 1
|
9 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any headache, dose 1
|
54 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 headache (prevented activities), dose 1
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any myalgia, dose 1
|
82 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 myalgia (prevented activities), dose 1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any systemic solicited symptom post-dose 2
|
17 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any fever ≥ 99.5°F ax or ≥ 100.4°F oral dose 2
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade3 fever > 103.1°F ax or> 104.0°F oral, dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any nausea/vomiting, dose 2
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade3 nausea/vomiting prevented activities ,dose2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any diarrhea, dose 2
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 diarrhea (prevented activities), dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any malaise, dose 2
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 malaise (prevented activities), dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 headache (prevented activities), dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Any myalgia, dose 2
|
7 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Grade 3 myalgia (prevented activities), dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days after vaccinationPopulation: Safety population
Outcome measures
| Measure |
Afluria Cohort A
n=254 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=250 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any myalgia
|
101 Participants
|
93 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 myalgia (prevented activities)
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any local solicited symptom post-dose 1
|
174 Participants
|
169 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any pain
|
167 Participants
|
151 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 pain (prevented activities)
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any redness (> 0 mm)
|
43 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 redness (> 30 mm)
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any swelling (> 0 mm)
|
39 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 swelling (> 30 mm)
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any systemic solicited symptom post-dose 1
|
144 Participants
|
126 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any fever (≥ 99.5°F ax or ≥ 100.4°F oral)
|
16 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 fever (> 103.1°F ax or > 104.0°F oral)
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any nausea/vomiting
|
23 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 nausea/vomiting (prevented activities)
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any diarrhea
|
20 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 diarrhea (prevented activities)
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any malaise
|
55 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 malaise (prevented activities)
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Any headache
|
69 Participants
|
66 Participants
|
—
|
—
|
—
|
—
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Grade 3 headache (prevented activities)
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after each vaccinationPopulation: Safety population
UAE stands for Unsolicited Adverse Events
Outcome measures
| Measure |
Afluria Cohort A
n=229 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=252 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
n=254 Participants
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
n=228 Participants
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
n=255 Participants
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
n=250 Participants
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Any related
|
37 Participants
|
24 Participants
|
20 Participants
|
16 Participants
|
18 Participants
|
14 Participants
|
|
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Any
|
123 Participants
|
100 Participants
|
88 Participants
|
112 Participants
|
84 Participants
|
70 Participants
|
|
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Grade 3
|
28 Participants
|
25 Participants
|
17 Participants
|
24 Participants
|
22 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 6 months after last study vaccinationPopulation: Safety population
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Outcome measures
| Measure |
Afluria Cohort A
n=229 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=252 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
n=254 Participants
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
n=228 Participants
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
n=255 Participants
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
n=250 Participants
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
New Onset of Chronic Illnesses (NOCIs)
Total number of participants with NOCI
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
New Onset of Chronic Illnesses (NOCIs)
Number of participants with related NOCI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
New Onset of Chronic Illnesses (NOCIs)
Asthma
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
New Onset of Chronic Illnesses (NOCIs)
Von Willebrand's Disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
New Onset of Chronic Illnesses (NOCIs)
Eczema
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
New Onset of Chronic Illnesses (NOCIs)
Attention deficit disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after last study vaccinationPopulation: Safety Population
Outcome measures
| Measure |
Afluria Cohort A
n=229 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=252 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
n=254 Participants
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
n=228 Participants
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
n=255 Participants
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
n=250 Participants
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Serious Adverse Events (SAEs)
Number of participants with SAEs
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events (SAEs)
Number of participants with related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days after each vaccinationPopulation: Safety population
Outcome measures
| Measure |
Afluria Cohort A
n=229 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=228 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any pain post-dose 1
|
1.57 Days
Standard Deviation 0.952
|
1.43 Days
Standard Deviation 0.728
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any redness (> 0 mm), post dose 1
|
2.09 Days
Standard Deviation 1.405
|
2.22 Days
Standard Deviation 1.939
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any swelling (> 0 mm), post dose 1
|
3.13 Days
Standard Deviation 2.930
|
2.00 Days
Standard Deviation 1.569
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any pain post-dose 2
|
1.54 Days
Standard Deviation 0.793
|
1.45 Days
Standard Deviation 0.739
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any redness (> 0 mm), post dose 2
|
1.80 Days
Standard Deviation 1.014
|
1.73 Days
Standard Deviation 0.935
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any swelling (> 0 mm), post dose 2
|
1.67 Days
Standard Deviation 0.707
|
1.57 Days
Standard Deviation 0.787
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral)
|
1.38 Days
Standard Deviation 0.869
|
1.49 Days
Standard Deviation 0.989
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any nausea/vomiting, post dose 1
|
1.42 Days
Standard Deviation 1.119
|
1.29 Days
Standard Deviation 1.042
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any diarrhea, post dose 1
|
2.23 Days
Standard Deviation 2.157
|
2.16 Days
Standard Deviation 2.189
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any loss of appetite, post dose 1
|
2.61 Days
Standard Deviation 3.695
|
2.85 Days
Standard Deviation 4.458
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any irritability, post dose 1
|
2.26 Days
Standard Deviation 2.858
|
2.64 Days
Standard Deviation 3.825
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral)
|
1.80 Days
Standard Deviation 1.146
|
1.81 Days
Standard Deviation 1.559
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any nausea/vomiting, post dose 2
|
2.50 Days
Standard Deviation 1.291
|
1.78 Days
Standard Deviation 1.093
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any diarrhea, post dose 2
|
2.83 Days
Standard Deviation 2.431
|
2.44 Days
Standard Deviation 2.332
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any loss of appetite, post dose 2
|
2.47 Days
Standard Deviation 1.586
|
2.33 Days
Standard Deviation 1.447
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Any irritability, post dose 2
|
2.31 Days
Standard Deviation 1.732
|
2.17 Days
Standard Deviation 1.543
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days after each vaccinationPopulation: Safety population
Outcome measures
| Measure |
Afluria Cohort A
n=252 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=255 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any pain post-dose 1
|
1.89 Days
Standard Deviation 1.138
|
1.89 Days
Standard Deviation 1.337
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any redness (> 0 mm), post dose 1
|
2.32 Days
Standard Deviation 1.621
|
2.10 Days
Standard Deviation 2.014
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any swelling (> 0 mm), post dose 1
|
2.39 Days
Standard Deviation 2.021
|
2.09 Days
Standard Deviation 1.273
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any pain post-dose 2
|
1.96 Days
Standard Deviation 1.637
|
1.65 Days
Standard Deviation 0.775
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any redness (> 0 mm), post dose 2
|
2.40 Days
Standard Deviation 2.191
|
1.77 Days
Standard Deviation 1.235
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any swelling (> 0 mm), post dose 2
|
3.00 Days
Standard Deviation 2.160
|
1.69 Days
Standard Deviation 1.251
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral)
|
1.45 Days
Standard Deviation 1.032
|
1.40 Days
Standard Deviation 0.707
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any nausea/vomiting, post dose 1
|
1.27 Days
Standard Deviation 0.719
|
1.43 Days
Standard Deviation 1.165
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any diarrhea, post dose 1
|
2.89 Days
Standard Deviation 4.988
|
1.44 Days
Standard Deviation 1.044
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any malaise, post dose 1
|
1.86 Days
Standard Deviation 1.324
|
1.74 Days
Standard Deviation 1.094
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any headache, post dose 1
|
1.50 Days
Standard Deviation 0.770
|
1.66 Days
Standard Deviation 1.328
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any myalgia, post dose 1
|
1.72 Days
Standard Deviation 1.007
|
1.63 Days
Standard Deviation 1.009
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral)
|
1.50 Days
Standard Deviation 0.577
|
1.00 Days
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any nausea/vomiting, post dose 2
|
1.00 Days
Standard Deviation 0.000
|
1.20 Days
Standard Deviation 0.447
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any diarrhea, post dose 2
|
1.33 Days
Standard Deviation 0.816
|
2.20 Days
Standard Deviation 0.447
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any malaise, post dose 2
|
1.83 Days
Standard Deviation 1.602
|
1.71 Days
Standard Deviation 0.756
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any headache, post dose 2
|
1.00 Days
Standard Deviation 0.000
|
1.30 Days
Standard Deviation 0.483
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort B
Any myalgia, post dose 2
|
2.00 Days
Standard Deviation 1.528
|
1.54 Days
Standard Deviation 0.660
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days after vaccinationPopulation: Safety population
Outcome measures
| Measure |
Afluria Cohort A
n=254 Participants
Age 6 months to \< 3 years
|
Fluzone Cohort A
n=250 Participants
Age 6 months to \< 3 years
|
Afluria Cohort C
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any diarrhea
|
1.18 Days
Standard Deviation 0.395
|
1.36 Days
Standard Deviation 0.911
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any malaise
|
2.09 Days
Standard Deviation 1.487
|
2.82 Days
Standard Deviation 3.449
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any headache
|
1.77 Days
Standard Deviation 1.443
|
2.05 Days
Standard Deviation 1.945
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any myalgia
|
1.76 Days
Standard Deviation 1.100
|
2.11 Days
Standard Deviation 1.491
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any pain
|
1.96 Days
Standard Deviation 1.087
|
1.99 Days
Standard Deviation 1.136
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any redness (> 0 mm)
|
2.02 Days
Standard Deviation 1.669
|
2.38 Days
Standard Deviation 1.992
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any swelling (> 0 mm)
|
1.75 Days
Standard Deviation 1.171
|
2.38 Days
Standard Deviation 1.724
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any fever (≥ 99.5°F ax or ≥ 100.4°F oral)
|
1.82 Days
Standard Deviation 1.590
|
3.10 Days
Standard Deviation 2.644
|
—
|
—
|
—
|
—
|
|
Duration of Local and Systemic Solicited Symptoms, Cohort C
Any nausea/vomiting
|
1.36 Days
Standard Deviation 0.569
|
2.88 Days
Standard Deviation 3.791
|
—
|
—
|
—
|
—
|
Adverse Events
Afluria Cohort A
Serious events: 4 serious events
Other events: 210 other events
Deaths: 0 deaths
Afluria Cohort B
Serious events: 3 serious events
Other events: 216 other events
Deaths: 0 deaths
Afluria Cohort C
Serious events: 2 serious events
Other events: 214 other events
Deaths: 0 deaths
Fluzone Cohort A
Serious events: 4 serious events
Other events: 187 other events
Deaths: 0 deaths
Fluzone Cohort B
Serious events: 0 serious events
Other events: 202 other events
Deaths: 0 deaths
Fluzone Cohort C
Serious events: 0 serious events
Other events: 202 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afluria Cohort A
n=231 participants at risk；n=229 participants at risk
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort B
n=254 participants at risk；n=252 participants at risk
Age 3 to \< 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort C
n=254 participants at risk
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
n=228 participants at risk
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
n=257 participants at risk；n=255 participants at risk
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
n=250 participants at risk
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.44%
1/229 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.44%
1/229 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Infections and infestations
Pneumonia
|
0.44%
1/229 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.40%
1/252 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Infections and infestations
Bronchiolitis
|
0.44%
1/229 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.44%
1/228 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.40%
1/252 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.40%
1/252 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.39%
1/254 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.39%
1/254 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.44%
1/228 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Infections and infestations
Furuncle
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.44%
1/228 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Infections and infestations
Respiratory syncitial virus bronchiolitis
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.44%
1/228 • Number of events 1 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
Other adverse events
| Measure |
Afluria Cohort A
n=231 participants at risk；n=229 participants at risk
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort B
n=254 participants at risk；n=252 participants at risk
Age 3 to \< 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Afluria Cohort C
n=254 participants at risk
Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
|
Fluzone Cohort A
n=228 participants at risk
Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort B
n=257 participants at risk；n=255 participants at risk
Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
Fluzone Cohort C
n=250 participants at risk
Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
|
|---|---|---|---|---|---|---|
|
General disorders
Pain at the injection site
|
46.7%
107/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
62.3%
157/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
65.7%
167/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
39.0%
89/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
52.5%
134/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
60.4%
151/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Redness at the injection site
|
26.2%
60/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
24.6%
62/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
16.9%
43/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
26.3%
60/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
26.3%
67/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
17.2%
43/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Swelling at the injection site
|
14.8%
34/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
15.1%
38/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
15.4%
39/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
12.7%
29/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
19.6%
50/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
16.4%
41/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Fever
|
39.7%
91/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
23.0%
58/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
6.3%
16/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
18.4%
42/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
11.4%
29/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
4.0%
10/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
13.5%
31/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
13.9%
35/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
9.1%
23/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
10.1%
23/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
9.4%
24/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
9.6%
24/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Gastrointestinal disorders
Diarrhea
|
4.4%
10/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
1.2%
3/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
1.6%
4/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
5.7%
13/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
1.2%
3/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.40%
1/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Loss of appetite
|
34.5%
79/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
23.7%
54/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Irritability
|
62.0%
142/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
43.4%
99/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Malaise
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
29.4%
74/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
21.7%
55/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
14.5%
37/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
20.4%
51/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Headache
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
23.0%
58/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
27.2%
69/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
17.6%
45/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
26.4%
66/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Myalgia
|
0.00%
0/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
34.5%
87/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
39.8%
101/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.00%
0/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
25.9%
66/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
37.2%
93/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
9/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.4%
6/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
1.6%
4/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
6.1%
14/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.0%
5/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
1.6%
4/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
39/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
15.9%
40/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
7.5%
19/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
13.6%
31/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
12.9%
33/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
6.8%
17/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.9%
25/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
5.6%
14/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.0%
5/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
10.5%
24/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
3.9%
10/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.0%
5/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.1%
14/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
3.2%
8/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
6.3%
16/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
4.8%
11/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
1.6%
4/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.4%
6/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
General disorders
Pyrexia
|
14.0%
32/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
9.5%
24/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
4.7%
12/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
9.6%
22/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
6.7%
17/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.8%
7/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Nervous system disorders
Headache
|
2.6%
6/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.4%
6/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
6.7%
17/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
1.3%
3/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
3.1%
8/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
4.8%
12/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
4/229 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.8%
7/252 • Adverse event data were collected for 180 days after the last study vaccination.
|
7.5%
19/254 • Adverse event data were collected for 180 days after the last study vaccination.
|
0.88%
2/228 • Adverse event data were collected for 180 days after the last study vaccination.
|
2.4%
6/255 • Adverse event data were collected for 180 days after the last study vaccination.
|
5.2%
13/250 • Adverse event data were collected for 180 days after the last study vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60