Trial Outcomes & Findings for A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age (NCT NCT02839330)
NCT ID: NCT02839330
Last Updated: 2024-12-06
Results Overview
Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3196 participants
Primary outcome timeframe
Day 1, Day 43
Results posted on
2024-12-06
Participant Flow
This study was conducted at 26 centers in the USA.
All enrolled subjects were included in the study. A total of 5 subjects were enrolled and randomized in error by sites. These subjects were deemed screen or randomization failures due to violation of the inclusion and/or exclusion criteria. Therefore, of the 3196 subjects enrolled in the study 3191 subjects were vaccinated.
Participant milestones
| Measure |
Group A: aH5N1c Lot #1
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
Group D: Placebo
Placebo; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
804
|
799
|
795
|
798
|
|
Overall Study
Exposed
|
804
|
797
|
793
|
797
|
|
Overall Study
COMPLETED
|
746
|
741
|
747
|
747
|
|
Overall Study
NOT COMPLETED
|
58
|
58
|
48
|
51
|
Reasons for withdrawal
| Measure |
Group A: aH5N1c Lot #1
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
Group D: Placebo
Placebo; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
2
|
|
Overall Study
Death
|
4
|
6
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
27
|
19
|
11
|
13
|
|
Overall Study
Lost to Follow-up
|
22
|
27
|
29
|
25
|
|
Overall Study
Administrative Reason
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
2
|
3
|
|
Overall Study
Other reason, not specified
|
4
|
3
|
3
|
6
|
Baseline Characteristics
N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
Baseline characteristics by cohort
| Measure |
Group A: aH5N1c Lot #1
n=804 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=799 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
n=795 Participants
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
Group D: Placebo
n=798 Participants
Placebo; receive 2 doses (on Day 1 and Day 22)
|
Total
n=3196 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=804 Participants
|
0 Participants
n=799 Participants
|
0 Participants
n=795 Participants
|
0 Participants
n=798 Participants
|
0 Participants
n=3196 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
403 Participants
n=804 Participants
|
399 Participants
n=799 Participants
|
397 Participants
n=795 Participants
|
398 Participants
n=798 Participants
|
1597 Participants
n=3196 Participants
|
|
Age, Categorical
>=65 years
|
401 Participants
n=804 Participants
|
400 Participants
n=799 Participants
|
398 Participants
n=795 Participants
|
400 Participants
n=798 Participants
|
1599 Participants
n=3196 Participants
|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 17.67 • n=804 Participants
|
57.5 years
STANDARD_DEVIATION 17.83 • n=799 Participants
|
57.5 years
STANDARD_DEVIATION 18.24 • n=795 Participants
|
57.7 years
STANDARD_DEVIATION 18.29 • n=798 Participants
|
57.7 years
STANDARD_DEVIATION 18.00 • n=3196 Participants
|
|
Sex: Female, Male
Female
|
444 Participants
n=804 Participants
|
434 Participants
n=799 Participants
|
447 Participants
n=795 Participants
|
438 Participants
n=798 Participants
|
1763 Participants
n=3196 Participants
|
|
Sex: Female, Male
Male
|
360 Participants
n=804 Participants
|
365 Participants
n=799 Participants
|
348 Participants
n=795 Participants
|
360 Participants
n=798 Participants
|
1433 Participants
n=3196 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53 Participants
n=804 Participants
|
61 Participants
n=799 Participants
|
64 Participants
n=795 Participants
|
55 Participants
n=798 Participants
|
233 Participants
n=3196 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
746 Participants
n=804 Participants
|
729 Participants
n=799 Participants
|
721 Participants
n=795 Participants
|
732 Participants
n=798 Participants
|
2928 Participants
n=3196 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=804 Participants
|
9 Participants
n=799 Participants
|
10 Participants
n=795 Participants
|
11 Participants
n=798 Participants
|
35 Participants
n=3196 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=804 Participants
|
4 Participants
n=799 Participants
|
5 Participants
n=795 Participants
|
3 Participants
n=798 Participants
|
18 Participants
n=3196 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=804 Participants
|
7 Participants
n=799 Participants
|
9 Participants
n=795 Participants
|
7 Participants
n=798 Participants
|
35 Participants
n=3196 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=804 Participants
|
2 Participants
n=799 Participants
|
1 Participants
n=795 Participants
|
4 Participants
n=798 Participants
|
10 Participants
n=3196 Participants
|
|
Race (NIH/OMB)
Black or African American
|
110 Participants
n=804 Participants
|
102 Participants
n=799 Participants
|
104 Participants
n=795 Participants
|
112 Participants
n=798 Participants
|
428 Participants
n=3196 Participants
|
|
Race (NIH/OMB)
White
|
668 Participants
n=804 Participants
|
679 Participants
n=799 Participants
|
674 Participants
n=795 Participants
|
665 Participants
n=798 Participants
|
2686 Participants
n=3196 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=804 Participants
|
NA Participants
n=799 Participants
|
NA Participants
n=795 Participants
|
NA Participants
n=798 Participants
|
NA Participants
n=3196 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=804 Participants
|
5 Participants
n=799 Participants
|
2 Participants
n=795 Participants
|
7 Participants
n=798 Participants
|
19 Participants
n=3196 Participants
|
|
Region of Enrollment
United States
|
804 participants
n=804 Participants
|
799 participants
n=799 Participants
|
795 participants
n=795 Participants
|
798 participants
n=798 Participants
|
3196 participants
n=3196 Participants
|
|
Weight
|
78.86 kg
STANDARD_DEVIATION 15.049 • n=804 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
80.22 kg
STANDARD_DEVIATION 15.165 • n=799 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
78.86 kg
STANDARD_DEVIATION 15.302 • n=794 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
79.84 kg
STANDARD_DEVIATION 15.255 • n=798 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
79.44 kg
STANDARD_DEVIATION 15.197 • n=3195 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
|
Height
|
169.38 cm
STANDARD_DEVIATION 9.596 • n=804 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
169.37 cm
STANDARD_DEVIATION 9.708 • n=799 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
169.37 cm
STANDARD_DEVIATION 10.153 • n=794 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
169.78 cm
STANDARD_DEVIATION 9.424 • n=798 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
169.47 cm
STANDARD_DEVIATION 9.720 • n=3195 Participants • N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
|
PRIMARY outcome
Timeframe: Day 1, Day 43Population: Per Protocol Set (PPS) - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample (lot-to-lot consistency) at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots.
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=761 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=747 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
n=741 Participants
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot
Day 1
|
16.1 geometric mean titer
Interval 15.1 to 17.2
|
17.0 geometric mean titer
Interval 15.9 to 18.2
|
17.0 geometric mean titer
Interval 15.9 to 18.2
|
|
Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot
Day 43
|
128.6 geometric mean titer
Interval 118.9 to 139.1
|
127.4 geometric mean titer
Interval 117.6 to 138.0
|
132.2 geometric mean titer
Interval 122.1 to 143.1
|
PRIMARY outcome
Timeframe: Day 1, Day 43Population: The PPS consisting of all subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons was used for analysis.
Percentage of subjects with HI titer ≥ 1:40 at Day 43 was assessed by age cohort (18 to \<65 years of age and ≥65 years of age) for the pooled lots. Center for Biologics Evaluation and Research (CBER) criterion for subjects aged 18 to \<65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2249 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=739 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort
Day 1, 18 to <65 years
|
13.0 percentage of subjects
Interval 10.7 to 15.6
|
15.0 percentage of subjects
Interval 11.5 to 19.4
|
—
|
|
Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort
Day 1, ≥65 Years
|
27.8 percentage of subjects
Interval 24.9 to 30.9
|
24.5 percentage of subjects
Interval 20.1 to 29.6
|
—
|
|
Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort
Day 43, 18 to <65 years
|
95.0 percentage of subjects
Interval 93.4 to 96.2
|
8.5 percentage of subjects
Interval 5.9 to 12.1
|
—
|
|
Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort
Day 43, ≥65 Years
|
85.7 percentage of subjects
Interval 83.3 to 87.9
|
20.8 percentage of subjects
Interval 16.6 to 25.8
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: The overall safety set consisting of all subjects who received a study vaccination who underwent any assessment of local and systemic site reaction and/or assessment of any use of analgesics/antipyretics was used for analysis.
Percentages of subjects with solicited local, solicited systemic, and other AEs as measured for 7 days (inclusive) following each vaccination (first and second) and any (first or second) vaccination, by treatment group and calculated for several time intervals after vaccination : 30 minutes, 1 to 3 days (without 30 minutes), 4 to 7 days, and 1 to 7 days (without 30 minutes), and 1 to 3 days (including 30 minutes) and 1 to 7 days (including 30 minutes). Analysis for intervals of the first 30 minutes, days 1 to 3, and days 4 to 7 was not performed.
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2395 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=796 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Loc AE, After Vac 1 (D1-D7 excl 30m)
|
43.2 percentage of subjects
|
10.2 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Any Solicited AE, After Any Vac (D1-D7 excl 30m)
|
59.7 percentage of subjects
|
38.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Loc AE, After Any Vac (D1-D7 excl 30m)
|
50.2 percentage of subjects
|
14.7 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Sys AE, After Any Vac (D1-D7 excl 30m)
|
38.2 percentage of subjects
|
32.8 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Any Solicited AE, After Vac 1 (D1-D7 excl 30m)
|
52.4 percentage of subjects
|
30.2 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Sys AE, After Vac 1 (D1-D7 excl 30m)
|
30.7 percentage of subjects
|
26.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Any Solicited AE, After Vac 2 (D1-D7 excl 30m)
|
41.1 percentage of subjects
|
22.3 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Loc AE, After Vac 2 (D1-D7 excl 30m)
|
33.9 percentage of subjects
|
7.4 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Sys AE, After Vac 2 (D1-D7 excl 30m)
|
21.3 percentage of subjects
|
18.6 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Any Solicited AE, After Any Vac (D1-D7)
|
59.3 percentage of subjects
|
38.7 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Loc AE, After Any Vac (D1-D7)
|
50.0 percentage of subjects
|
16.3 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Sys AE, After Any Vac (D1-D7)
|
37.7 percentage of subjects
|
32.5 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Any Solicited AE, After Vac 1 (D1-D7)
|
52.0 percentage of subjects
|
30.3 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Loc AE, After Vac 1 (D1-D7)
|
42.8 percentage of subjects
|
11.1 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Sys AE, After Vac 1 (D1-D7)
|
30.3 percentage of subjects
|
25.5 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Any Solicited AE, After Vac 2 (D1-D7)
|
41.0 percentage of subjects
|
23.1 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Loc AE, After Vac 2 (D1-D7)
|
34.1 percentage of subjects
|
8.3 percentage of subjects
|
—
|
|
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Solicited Sys AE, After Vac 2 (D1-D7)
|
21.2 percentage of subjects
|
18.9 percentage of subjects
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Population: The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis.
Percentages of subjects with any unsolicited AEs reported through 21 days after each (first and second) and any (first or second) vaccination by treatment group.
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2395 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=796 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Unsolicited AE, V2
|
12.2 percentage of subjects
|
11.9 percentage of subjects
|
—
|
|
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Unsolicited AEs, V1 or V2
|
23.4 percentage of subjects
|
22.2 percentage of subjects
|
—
|
|
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Possibly/probably related unsolicited AE, V1 or V2
|
7.0 percentage of subjects
|
6.2 percentage of subjects
|
—
|
|
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Unsolicited AE, V1
|
15.3 percentage of subjects
|
13.2 percentage of subjects
|
—
|
|
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Possibly/probably related unsolicited AE, V1
|
4.8 percentage of subjects
|
3.8 percentage of subjects
|
—
|
|
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Possibly/probably related unsolicited AE, V2
|
2.8 percentage of subjects
|
2.8 percentage of subjects
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 387Population: The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis.
Percentages of subjects with any adverse events (AE), adverse events of special interest (AESI), new onset of chronic disease (NOCD), and serious adverse event (SAE) through study termination by treatment group.
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2395 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=796 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
SAE
|
6.7 percentage of subjects
|
9.3 percentage of subjects
|
—
|
|
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
Possibly or probably related SAEs
|
0 percentage of subjects
|
0.3 percentage of subjects
|
—
|
|
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
AEs leading to premature withdrawal
|
0.5 percentage of subjects
|
0.4 percentage of subjects
|
—
|
|
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
Medically attended AEs
|
46.5 percentage of subjects
|
46.0 percentage of subjects
|
—
|
|
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
AEs leading to NOCD
|
9.5 percentage of subjects
|
9.2 percentage of subjects
|
—
|
|
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
AESI
|
0.3 percentage of subjects
|
0.9 percentage of subjects
|
—
|
|
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
AE leading to death
|
0.5 percentage of subjects
|
0.1 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 43, and Day 183Population: PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Estimates of hemagglutination inhibition (HI) GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1).
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2249 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=739 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 1
|
16.6 titer
Interval 16.0 to 17.3
|
16.7 titer
Interval 15.6 to 17.9
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 1, 18 to <65 years
|
13.5 titer
Interval 12.8 to 14.2
|
13.7 titer
Interval 12.5 to 15.0
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 1, ≥65 years
|
20.5 titer
Interval 19.4 to 21.8
|
20.6 titer
Interval 18.6 to 22.7
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22
|
46.4 titer
Interval 44.5 to 48.4
|
13.0 titer
Interval 12.1 to 14.0
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22, 18 to <65 years
|
50.6 titer
Interval 47.6 to 53.8
|
11.6 titer
Interval 10.4 to 12.9
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22, ≥65 years
|
42.4 titer
Interval 40.0 to 45.0
|
14.5 titer
Interval 13.1 to 16.0
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43
|
130.6 titer
Interval 124.8 to 136.6
|
13.7 titer
Interval 12.6 to 14.8
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43, 18 to <65 years
|
170.7 titer
Interval 160.5 to 181.6
|
11.0 titer
Interval 9.9 to 12.2
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43, ≥65 years
|
97.9 titer
Interval 92.1 to 104.1
|
16.7 titer
Interval 15.0 to 18.5
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 183
|
20.0 titer
Interval 19.2 to 20.8
|
7.7 titer
Interval 7.2 to 8.2
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 183, 18 to <65 years
|
20.4 titer
Interval 19.3 to 21.6
|
6.8 titer
Interval 6.1 to 7.4
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 183, ≥65 years
|
19.3 titer
Interval 18.2 to 20.4
|
8.6 titer
Interval 7.8 to 9.5
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 43 and Day 183Population: PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort are presented. CBER criterion for subjects aged 18 to \<65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2249 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=739 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22
|
59.3 percentage of subjects
Interval 57.2 to 61.3
|
14.9 percentage of subjects
Interval 12.4 to 17.7
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 1, ≥65 years
|
28.2 percentage of subjects
Interval 25.6 to 31.0
|
25.6 percentage of subjects
Interval 21.2 to 30.4
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 1
|
22.9 percentage of subjects
Interval 21.1 to 24.6
|
22.6 percentage of subjects
Interval 19.6 to 25.8
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 1, 18 to <65 years
|
17.4 percentage of subjects
Interval 15.2 to 19.7
|
19.6 percentage of subjects
Interval 15.7 to 24.0
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22, 18 to <65 years
|
63.0 percentage of subjects
Interval 60.1 to 65.9
|
13.5 percentage of subjects
Interval 10.2 to 17.4
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22, ≥65 years
|
55.6 percentage of subjects
Interval 52.6 to 58.5
|
16.4 percentage of subjects
Interval 12.7 to 20.6
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43
|
88.3 percentage of subjects
Interval 86.9 to 89.6
|
16.9 percentage of subjects
Interval 14.2 to 19.8
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43, 18 to <65 years
|
93.1 percentage of subjects
Interval 91.4 to 94.6
|
10.9 percentage of subjects
Interval 7.8 to 14.6
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43, ≥65 years
|
83.5 percentage of subjects
Interval 81.2 to 85.7
|
22.8 percentage of subjects
Interval 18.5 to 27.5
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 183
|
32.6 percentage of subjects
Interval 30.6 to 34.6
|
5.2 percentage of subjects
Interval 3.7 to 7.2
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 183, 18 to <65 years
|
34.2 percentage of subjects
Interval 31.3 to 37.2
|
2.1 percentage of subjects
Interval 0.8 to 4.2
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 183, ≥65 years
|
30.9 percentage of subjects
Interval 28.1 to 33.8
|
8.4 percentage of subjects
Interval 5.7 to 11.8
|
—
|
SECONDARY outcome
Timeframe: Day 22, and Day 43Population: PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline \[HI titer \<1:10\]; or a minimum 4-fold increase in HI titer for subjects positive at baseline \[HI titer ≥1:10\]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to \<65 years of age and ≥65 years of age).
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2249 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=739 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22
|
32.2 percentage of subjects
Interval 30.3 to 34.2
|
1.1 percentage of subjects
Interval 0.5 to 2.1
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22, 18 to <65 years
|
40.4 percentage of subjects
Interval 37.6 to 43.4
|
1.9 percentage of subjects
Interval 0.8 to 3.9
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 22, ≥65 years
|
24.2 percentage of subjects
Interval 21.7 to 26.8
|
0.3 percentage of subjects
Interval 0.0 to 1.5
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43
|
66.9 percentage of subjects
Interval 64.9 to 68.9
|
1.0 percentage of subjects
Interval 0.4 to 2.0
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43, 18 to <65 years
|
79.9 percentage of subjects
Interval 77.4 to 82.3
|
0.3 percentage of subjects
Interval 0.0 to 1.6
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Day 43, ≥65 Years
|
54.0 percentage of subjects
Interval 51.0 to 57.0
|
1.7 percentage of subjects
Interval 0.6 to 3.7
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 43 and Day 183Population: PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Hemagglutination inhibition (HI) GMTs were assessed over time for the vaccine group and age cohort. Adjusted estimates of GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1).
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2249 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=739 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 1, 18 to <60 years
|
13.0 titer
Interval 12.3 to 13.8
|
13.4 titer
Interval 12.2 to 14.7
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 1, ≥60 years
|
20.1 titer
Interval 19.1 to 21.3
|
20.1 titer
Interval 18.3 to 22.0
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22, 18 to <60 years
|
51.1 titer
Interval 47.9 to 54.6
|
11.2 titer
Interval 10.0 to 12.5
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22, ≥60 years
|
42.9 titer
Interval 40.5 to 45.3
|
14.4 titer
Interval 13.1 to 15.9
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43, 18 to <60 years
|
177.4 titer
Interval 166.2 to 189.4
|
10.7 titer
Interval 9.5 to 11.9
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43, ≥60 years
|
100.7 titer
Interval 95.0 to 106.7
|
16.2 titer
Interval 14.7 to 17.9
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 183, 18 to <60 years
|
20.4 titer
Interval 19.3 to 21.7
|
6.7 titer
Interval 6.0 to 7.4
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 183, ≥60 years
|
19.3 titer
Interval 18.3 to 20.4
|
8.5 titer
Interval 7.7 to 9.3
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 43, and Day 183Population: PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort. Committee for Medicinal Products for Human Use (CHMP) criterion for subjects aged 18 to \<60 years: The percentage of subjects achieving an HI titer ≥1:40 is \>70%. CHMP criterion for subjects aged ≥60 years: The percentage of subjects achieving an HI titer ≥1:40 is \>60%.
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2249 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=739 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 1, 18 to <60 years
|
17.1 percentage of subjects
Interval 14.8 to 19.7
|
19.6 percentage of subjects
Interval 15.5 to 24.3
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 1, ≥60 years
|
27.3 percentage of subjects
Interval 24.8 to 29.8
|
25.0 percentage of subjects
Interval 20.9 to 29.5
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22, 18 to <60 years
|
63.2 percentage of subjects
Interval 60.1 to 66.3
|
12.2 percentage of subjects
Interval 8.8 to 16.2
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22, ≥60 years
|
56.2 percentage of subjects
Interval 53.5 to 59.0
|
17.2 percentage of subjects
Interval 13.7 to 21.2
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43, 18 to <60 years
|
93.6 percentage of subjects
Interval 91.8 to 95.0
|
10.0 percentage of subjects
Interval 6.9 to 13.9
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43, ≥60 years
|
84.2 percentage of subjects
Interval 82.0 to 86.2
|
22.3 percentage of subjects
Interval 18.2 to 26.7
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 183, 18 to <60 years
|
34.3 percentage of subjects
Interval 31.2 to 37.5
|
2.3 percentage of subjects
Interval 0.9 to 4.7
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 183, ≥60 years
|
31.3 percentage of subjects
Interval 28.6 to 34.0
|
7.5 percentage of subjects
Interval 5.1 to 10.6
|
—
|
SECONDARY outcome
Timeframe: Day 22, and Day 43Population: PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline \[HI titer \<1:10\]; or a minimum 4-fold increase in HI titer for subjects positive at baseline \[HI titer ≥1:10\]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to \<60 years of age and ≥60 years of age)
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2249 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=739 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22, 18 to <60 years
|
42.2 percentage of subjects
Interval 39.1 to 45.4
|
1.5 percentage of subjects
Interval 0.5 to 3.5
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22, ≥60 years
|
24.6 percentage of subjects
Interval 22.2 to 27.0
|
0.7 percentage of subjects
Interval 0.2 to 2.1
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43, 18 to <60 years
|
81.6 percentage of subjects
Interval 79.0 to 84.0
|
0.3 percentage of subjects
Interval 0.0 to 1.8
|
—
|
|
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43, ≥60 years
|
55.4 percentage of subjects
Interval 52.6 to 58.2
|
1.5 percentage of subjects
Interval 0.6 to 3.3
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 43Population: PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
The GMR of HI titers (Day 22/Day 1, Day 43/Day 1) is presented for the vaccine groups and age cohort. CHMP criterion for subjects aged 18 to \<60 years: GMR is \>2.5. CHMP criterion for subjects aged ≥60 years: GMR is \>2.0.
Outcome measures
| Measure |
Group A: aH5N1c Lot #1
n=2249 Participants
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
|
Group B: aH5N1c Lot #2
n=739 Participants
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
|
Group C: aH5N1c Lot #3
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|---|
|
Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22/Day 1, Overall
|
2.86 ratio
Interval 2.74 to 2.98
|
0.80 ratio
Interval 0.77 to 0.9
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43/Day 1, Overall
|
7.96 ratio
Interval 7.61 to 8.33
|
0.83 ratio
Interval 0.74 to 0.86
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22/Day 1, 18 to <60 years
|
3.92 ratio
Interval 3.67 to 4.18
|
0.85 ratio
Interval 0.76 to 0.96
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 22/Day 1, ≥60 years
|
2.22 ratio
Interval 2.1 to 2.35
|
0.75 ratio
Interval 0.68 to 0.82
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43/Day 1, 18 to <60 years
|
13.44 ratio
Interval 12.59 to 14.35
|
0.81 ratio
Interval 0.72 to 0.9
|
—
|
|
Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Day 43/Day 1, ≥60 years
|
5.18 ratio
Interval 4.88 to 5.49
|
0.83 ratio
Interval 0.76 to 0.92
|
—
|
Adverse Events
aH5N1c
Serious events: 161 serious events
Other events: 91 other events
Deaths: 11 deaths
Placebo
Serious events: 74 serious events
Other events: 44 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
aH5N1c
n=2395 participants at risk
aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22)
|
Placebo
n=796 participants at risk
Placebo; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
8/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
1.0%
8/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Coronary artery disease
|
0.13%
3/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.38%
3/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.50%
4/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
4/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.38%
3/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Angina pectoris
|
0.13%
3/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Atrial flutter
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Atrioventricular block
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Angina unstable
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Arrhythmia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Bradycardia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Sinus tachycardia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Gastritis alcoholic
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Nausea
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.25%
2/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Colitis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Constipation
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Gastritis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
General disorders
Non-cardiac chest pain
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
General disorders
Chest pain
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
General disorders
Death
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
General disorders
Perforated ulcer
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Hepatobiliary disorders
Biliary cirrhosis primary
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Immune system disorders
Food allergy
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Immune system disorders
Sarcoidosis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Pneumonia
|
0.17%
4/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.25%
2/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Diverticulitis
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Hepatobiliary disorders
Appendicitis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Bronchitis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Gastroenteritis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Sepsis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Septic shock
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Urinary tract infection
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Device related infection
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Endocarditis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Enterococcal infection
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
External ear cellulitis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Gallbladder abscess
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Incision site cellulitis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Influenza
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Labyrinthitis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Metapneumovirus infection
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Shigella infection
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Soft tissue infection
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Infections and infestations
Urosepsis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.17%
4/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.25%
2/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
15/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.50%
4/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.13%
3/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.21%
5/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.25%
2/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Surgical and medical procedures
Hospitalisation
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Vascular disorders
Aortic stenosis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Syncope
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.38%
3/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.13%
3/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Cerebellar stroke
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Encephalopathy
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Cerebral haematoma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Cerebral infarction
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Hypoaesthesia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Nervous system disorders
Presyncope
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.13%
3/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Renal and urinary disorders
Renal failure
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Renal and urinary disorders
Urinary retention
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Renal and urinary disorders
Adenomyosis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Renal and urinary disorders
Benign prostatic hyperplasia
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.21%
5/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.25%
2/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.13%
3/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.50%
4/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
2/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.25%
2/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.25%
2/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Vascular disorders
Aortic aneurysm
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.13%
1/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Vascular disorders
Haematoma
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Vascular disorders
Hypertension
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Vascular disorders
Orthostatic hypotension
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
|
Vascular disorders
Thrombosis
|
0.04%
1/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
0.00%
0/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
Other adverse events
| Measure |
aH5N1c
n=2395 participants at risk
aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22)
|
Placebo
n=796 participants at risk
Placebo; receive 2 doses (on Day 1 and Day 22)
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
91/2395 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
5.5%
44/796 • Day 1 to Day 387
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred). After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60