Trial Outcomes & Findings for A Safety and Immunogenicity Study of IVACFLU-A/H5N1 (NCT NCT02612909)
NCT ID: NCT02612909
Last Updated: 2019-05-21
Results Overview
Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
930 participants
Primary outcome timeframe
Day 1, Day 43
Results posted on
2019-05-21
Participant Flow
Phase 2 \& 3: Recruitment occurred from communes affiliated with the District Health Centers. Commune health workers identified potential participants through home visits and invited interested people to attend an information session. People heard about the study and those interested had individual consent for screening.
Participant milestones
| Measure |
Phase 2: Placebo
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2
STARTED
|
100
|
100
|
100
|
0
|
0
|
|
Phase 2
Received Injection 1
|
100
|
100
|
100
|
0
|
0
|
|
Phase 2
Received Injection 2
|
98
|
95
|
99
|
0
|
0
|
|
Phase 2
Completed Day 29 Clinic Visit
|
98
|
95
|
99
|
0
|
0
|
|
Phase 2
Completed Day 43 Clinic Visit
|
97
|
94
|
99
|
0
|
0
|
|
Phase 2
COMPLETED
|
98
|
95
|
99
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
2
|
5
|
1
|
0
|
0
|
|
Phase 3
STARTED
|
0
|
0
|
0
|
105
|
525
|
|
Phase 3
Received Injection 1
|
0
|
0
|
0
|
105
|
525
|
|
Phase 3
Received Injection 2
|
0
|
0
|
0
|
103
|
520
|
|
Phase 3
Completed Day 29 Clinic Visit
|
0
|
0
|
0
|
104
|
525
|
|
Phase 3
Completed Day 43 Clinic Visit
|
0
|
0
|
0
|
104
|
524
|
|
Phase 3
COMPLETED
|
0
|
0
|
0
|
104
|
525
|
|
Phase 3
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase 2: Placebo
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2
Withdrawal by Subject
|
2
|
5
|
0
|
0
|
0
|
|
Phase 2
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
|
Phase 3
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Safety and Immunogenicity Study of IVACFLU-A/H5N1
Baseline characteristics by cohort
| Measure |
Phase 2: Placebo
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
n=105 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
n=525 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Total
n=930 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 9.62 • n=93 Participants
|
39.8 years
STANDARD_DEVIATION 9.99 • n=4 Participants
|
39.7 years
STANDARD_DEVIATION 9.63 • n=27 Participants
|
39.9 years
STANDARD_DEVIATION 9.61 • n=483 Participants
|
40.2 years
STANDARD_DEVIATION 9.72 • n=36 Participants
|
40.0 years
STANDARD_DEVIATION 9.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
66 Participants
n=483 Participants
|
286 Participants
n=36 Participants
|
550 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
239 Participants
n=36 Participants
|
380 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Kinh
|
100 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
105 Participants
n=483 Participants
|
524 Participants
n=36 Participants
|
929 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 43Population: Subjects who received 2 injections and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=98 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=95 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=99 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
n=45 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
n=222 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40
Day 43
|
0 Participants
|
79 Participants
|
81 Participants
|
0 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 22Population: Subjects who received 2 injections and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=98 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=95 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=99 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2: Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase 2: Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40
Day 22
|
0 Participants
|
42 Participants
|
56 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22, Day 43Population: Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=98 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=95 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=99 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer
Day 22
|
0 Participants
|
57 Participants
|
70 Participants
|
—
|
—
|
|
Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer
Day 43
|
0 Participants
|
88 Participants
|
93 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 43Population: Subjects who received 2 injections and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=45 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=222 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer
|
0 Participants
|
150 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 43Population: Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=98 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=95 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=99 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer
Day 1
|
5.48 titer
Interval 5.23 to 5.74
|
5.62 titer
Interval 5.34 to 5.91
|
5.68 titer
Interval 5.3 to 6.1
|
—
|
—
|
|
Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer
Day 22
|
5.52 titer
Interval 5.26 to 5.8
|
31.67 titer
Interval 24.6 to 40.77
|
42.16 titer
Interval 33.45 to 53.13
|
—
|
—
|
|
Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer
Day 43
|
5.63 titer
Interval 5.31 to 5.96
|
62.65 titer
Interval 52.1 to 75.34
|
59.20 titer
Interval 49.87 to 70.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 43Population: Subjects who received 2 injections and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=45 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=222 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer
Day 1
|
5.04 titer
Interval 4.96 to 5.11
|
5.08 titer
Interval 4.97 to 5.18
|
—
|
—
|
—
|
|
Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer
Day 43
|
5.20 titer
Interval 5.06 to 5.34
|
27.61 titer
Interval 24.38 to 31.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22, Day 43Population: Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=98 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=95 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=99 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1
Day 22
|
1.01 fold change
Interval 0.99 to 1.02
|
5.64 fold change
Interval 4.43 to 7.18
|
7.42 fold change
Interval 5.93 to 9.27
|
—
|
—
|
|
Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1
Day 43
|
1.03 fold change
Interval 1.0 to 1.05
|
11.15 fold change
Interval 9.35 to 13.29
|
10.41 fold change
Interval 8.79 to 12.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 43Population: Subjects who received 2 injections and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=45 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=222 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1
|
1.01 fold change
Interval 0.99 to 1.02
|
5.31 fold change
Interval 4.69 to 6.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes after each injectionPopulation: Subjects who received injections
Immediate reactogenicity (30 minutes post-injection) were evaluated on Day 1 and Day 22 and consisted of: * Inspection of the upper arms for the presence or absence of redness, swelling, hardness, pain, or tenderness; and * Documentation of the presence or absence of headache, fever, fatigue/malaise, muscle aches, joint aches, nausea, vomiting, or chills. Immediate reactogenicity were assessed by a study physician or appropriately trained medical staff.
Outcome measures
| Measure |
Phase 2: Placebo
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
n=105 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
n=525 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects Experiencing Reactogenicity
Injection 2: any local reaction
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number and Percentage of Subjects Experiencing Reactogenicity
Injection 2: any systemic reaction
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number and Percentage of Subjects Experiencing Reactogenicity
Injection 1: any local reaction
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Reactogenicity
Injection 1: any systemic reaction
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days after each vaccinationPopulation: Subjects who received injections
Reported solicited signs and symptoms were recorded by the subject on the Diary Card from Days 1-7 and Days 22-28 in the study, then evaluated by study physician on Days 8, 22, and 29.The evaluated solicited local reactogenicity events were as follows: * Size of redness (at site of injection) in centimeters (cm) * Size of swelling (at site of injection) in cm * Size of induration (hardness at site of injection) in cm * Pain (at site of injection) * Tenderness (at site of injection) The evaluated solicited systemic reactogenicity events were as follows: * Fever/body temperature (and body location of measurement) * Fatigue/malaise * Generalized muscle aches * Joint aches/pains * Chills * Nausea * Vomiting * Headache
Outcome measures
| Measure |
Phase 2: Placebo
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
n=105 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
n=525 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects Experiencing Reactogenicity
Injection 1: any local reaction
|
22 Participants
|
83 Participants
|
87 Participants
|
19 Participants
|
409 Participants
|
|
Number and Percentage of Subjects Experiencing Reactogenicity
Injection 1: any systemic reaction
|
52 Participants
|
66 Participants
|
83 Participants
|
36 Participants
|
286 Participants
|
|
Number and Percentage of Subjects Experiencing Reactogenicity
Injection 2: any local reaction
|
12 Participants
|
44 Participants
|
50 Participants
|
15 Participants
|
227 Participants
|
|
Number and Percentage of Subjects Experiencing Reactogenicity
Injection 2: any systemic reaction
|
29 Participants
|
31 Participants
|
37 Participants
|
19 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: 21 days after each vaccinationPopulation: Subjects who received injections
Unsolicited AEs were any AEs that occurred any time after study product was given (temporally related to study product), whether or not deemed "related" to the product, and were not solicited. Unsolicited AEs were either observed by study staff while the subject was at a clinic for a study visit or reported by the subject at any time. Any solicited sign or symptom starting after 7 days post-study product injection was recorded as an "unsolicited AE". For the Phase 2 study, laboratory results were considered AEs when the result was Grade 2 or above. Any medical condition that was present at the time that the subject was enrolled was not reported as an AE, but was reported as a pre-existing condition on the Medical History Form. However, if this condition occurred with greater frequency or severity during the study, it was recorded as an AE.
Outcome measures
| Measure |
Phase 2: Placebo
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
n=105 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
n=525 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
Injection 1: at least 1 severe AE
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
Injection 1: at least 1 treatment-related AE
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
Injection 2: at least 1 severe AE
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
Injection 1: at least one AE
|
21 Participants
|
20 Participants
|
24 Participants
|
16 Participants
|
73 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
Injection 2: at least one AE
|
6 Participants
|
10 Participants
|
11 Participants
|
16 Participants
|
56 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
Injection 2: at least 1 treatment-related AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Subjects who received injections
Defined as an adverse event that led to death, was life-threatening (subject at immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in congenital anomaly/birth defect; resulted in a persistent or significant disability or incapacity.
Outcome measures
| Measure |
Phase 2: Placebo
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=100 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
n=105 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
n=525 Participants
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Number and Percentage of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 22, Day 43Population: Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured
The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture.
Outcome measures
| Measure |
Phase 2: Placebo
n=98 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=95 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=99 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer
Day 22
|
0 Participants
|
21 Participants
|
26 Participants
|
—
|
—
|
|
Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer
Day 43
|
0 Participants
|
57 Participants
|
63 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 43Population: Subjects who received 2 injections and had valid sera samples for the day measured
The MN assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. In Phase 3, MN assay was conducted in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in order to have at least 200 evaluable subjects receiving IVACFLU A/H5N1 and 40 evaluable subjects receiving placebo.
Outcome measures
| Measure |
Phase 2: Placebo
n=45 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=222 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer
|
0 Participants
|
114 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 43Population: Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured
The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture.
Outcome measures
| Measure |
Phase 2: Placebo
n=98 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=95 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=99 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2: Geometric Mean Neutralizing Antibody Titer
Day 1
|
7.15 titer
Interval 7.03 to 7.26
|
7.10 titer
Interval 7.04 to 7.15
|
7.19 titer
Interval 7.07 to 7.33
|
—
|
—
|
|
Phase 2: Geometric Mean Neutralizing Antibody Titer
Day 22
|
7.12 titer
Interval 7.02 to 7.22
|
13.78 titer
Interval 11.23 to 16.92
|
29.76 titer
Interval 24.47 to 36.2
|
—
|
—
|
|
Phase 2: Geometric Mean Neutralizing Antibody Titer
Day 43
|
7.12 titer
Interval 7.02 to 7.22
|
29.76 titer
Interval 24.47 to 36.2
|
28.48 titer
Interval 24.34 to 33.32
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 43Population: Subjects who received 2 injections and had valid sera samples for the day measured
Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.
Outcome measures
| Measure |
Phase 2: Placebo
n=45 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=222 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 3: Geometric Mean Neutralizing Antibody Titer
Day 1
|
7.07 titer
Interval 7.07 to 7.07
|
7.07 titer
Interval 7.07 to 7.07
|
—
|
—
|
—
|
|
Phase 3: Geometric Mean Neutralizing Antibody Titer
Day 43
|
7.07 titer
Interval 7.07 to 7.07
|
26.16 titer
Interval 22.66 to 30.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22, Day 43Population: Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured
The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture.
Outcome measures
| Measure |
Phase 2: Placebo
n=98 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=95 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=99 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 2: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1
Day 43
|
1.00 fold change
Interval 0.99 to 1.0
|
4.19 fold change
Interval 3.46 to 5.09
|
3.96 fold change
Interval 3.38 to 4.63
|
—
|
—
|
|
Phase 2: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1
Day 22
|
1.00 fold change
Interval 0.99 to 1.0
|
1.94 fold change
Interval 1.59 to 2.38
|
2.02 fold change
Interval 1.67 to 2.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 43Population: Subjects who received 2 injections and had valid sera samples for the day measured
The MN assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. In Phase 3, MN assay was conducted in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in order to have at least 200 evaluable subjects receiving IVACFLU A/H5N1 and 40 evaluable subjects receiving placebo.
Outcome measures
| Measure |
Phase 2: Placebo
n=45 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=222 Participants
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Phase 3: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1
|
1.00 fold change
Interval 1.0 to 1.0
|
3.70 fold change
Interval 3.21 to 4.27
|
—
|
—
|
—
|
Adverse Events
Phase 2: Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Phase 2: Vaccine (15 mcg)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase 2: Vaccine (30 mcg)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Phase 3: Placebo
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Phase 3: Vaccine
Serious events: 8 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2: Placebo
n=100 participants at risk
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=100 participants at risk
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=100 participants at risk
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
n=105 participants at risk
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
n=525 participants at risk
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal adhesion
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Viral fever
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
Other adverse events
| Measure |
Phase 2: Placebo
n=100 participants at risk
Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (15 mcg)
n=100 participants at risk
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 2: Vaccine (30 mcg)
n=100 participants at risk
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Placebo
n=105 participants at risk
Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.
|
Phase 3: Vaccine
n=525 participants at risk
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Insomnia
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Periodontal inflammation
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
3/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
3.0%
3/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Varicella
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Investigations
Blood creatinine increased
|
4.0%
4/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Investigations
Blood pressure increased
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Investigations
White blood cell count increased
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Nervous system disorders
Dizziness
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Nervous system disorders
Headache
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Nervous system disorders
Vestibular disorder
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.0%
2/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.57%
3/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
5/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
5.0%
5/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
6.0%
6/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
3.0%
3/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.76%
4/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
General disorders
Fatigue
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Immune system disorders
Rhinitis allergic
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.0%
1/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.1%
6/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.9%
2/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.38%
2/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
General disorders
Burning sensation
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
General disorders
Inflammation
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.76%
4/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
General disorders
Pain
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
General disorders
Pyrexia
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.38%
2/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Immune system disorders
Urticaria
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.38%
2/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Ear infection
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Fungal infection
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Hordeolum
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
4.8%
5/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.1%
11/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Sinusitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.9%
3/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
2.3%
12/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Gastritis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Gingivitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Headache
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.76%
4/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.57%
3/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Nervous system disorders
Back pain
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Nervous system disorders
Sciatica
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Nervous system disorders
Vertigo
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.57%
3/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Herpes Zoster
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.9%
2/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Vascular disorders
Hypertension
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.9%
10/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Vascular disorders
Injection site bruising
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Eye disorders
Refraction disorder
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Gastrointestinal disorders
Pharyngitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Appendicitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Cervicitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Sebaceous gland infection
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.38%
2/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Viral infection
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Infections and infestations
Wound infection
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Abdominal adhesion
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.9%
2/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
1.1%
6/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Injury, poisoning and procedural complications
Neck pain
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.38%
2/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.95%
1/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Subcutaneous abscess
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/100 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.00%
0/105 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
0.19%
1/525 • 21 days for non-serious adverse events, 90 days for serious adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place