Trial Outcomes & Findings for Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59 (NCT NCT03497845)
NCT ID: NCT03497845
Last Updated: 2020-07-14
Results Overview
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
720 participants
Primary outcome timeframe
8 days post-vaccination
Results posted on
2020-07-14
Participant Flow
Participant milestones
| Measure |
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
58
|
61
|
60
|
59
|
62
|
59
|
60
|
61
|
59
|
61
|
60
|
|
Overall Study
COMPLETED
|
55
|
45
|
50
|
50
|
38
|
44
|
51
|
50
|
47
|
53
|
46
|
38
|
|
Overall Study
NOT COMPLETED
|
5
|
13
|
11
|
10
|
21
|
18
|
8
|
10
|
14
|
6
|
15
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
Baseline characteristics by cohort
| Measure |
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=60 Participants
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=58 Participants
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=61 Participants
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
n=60 Participants
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=59 Participants
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=62 Participants
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=59 Participants
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=60 Participants
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=61 Participants
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
n=59 Participants
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=61 Participants
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=60 Participants
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
Total
n=720 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Age of Participants · 18-<30 years old
|
23 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
21 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
18 Participants
n=40 Participants
|
34 Participants
n=8 Participants
|
18 Participants
n=62 Participants
|
22 Participants
n=95 Participants
|
25 Participants
n=129 Participants
|
284 Participants
n=36 Participants
|
|
Age, Customized
Age of Participants · 30-<40 years old
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
17 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
22 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
26 Participants
n=62 Participants
|
14 Participants
n=95 Participants
|
19 Participants
n=129 Participants
|
219 Participants
n=36 Participants
|
|
Age, Customized
Age of Participants · 40-49 years old
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
20 Participants
n=40 Participants
|
14 Participants
n=8 Participants
|
15 Participants
n=62 Participants
|
25 Participants
n=95 Participants
|
16 Participants
n=129 Participants
|
217 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
31 Participants
n=10 Participants
|
43 Participants
n=115 Participants
|
31 Participants
n=40 Participants
|
42 Participants
n=8 Participants
|
28 Participants
n=62 Participants
|
35 Participants
n=95 Participants
|
38 Participants
n=129 Participants
|
430 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
31 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
29 Participants
n=40 Participants
|
19 Participants
n=8 Participants
|
31 Participants
n=62 Participants
|
26 Participants
n=95 Participants
|
22 Participants
n=129 Participants
|
290 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race of Participants · White
|
51 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
47 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
48 Participants
n=40 Participants
|
45 Participants
n=8 Participants
|
41 Participants
n=62 Participants
|
42 Participants
n=95 Participants
|
42 Participants
n=129 Participants
|
535 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race of Participants · Black or African American
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
11 Participants
n=62 Participants
|
14 Participants
n=95 Participants
|
8 Participants
n=129 Participants
|
122 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race of Participants · Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
19 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race of Participants · American Indian or Alaska Native
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race of Participants · Native Hawaiian or Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race of Participants · Multiracial
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
7 Participants
n=129 Participants
|
40 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race of Participants · Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Ethnicity of Participants · Hispanic or Latino
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
7 Participants
n=95 Participants
|
5 Participants
n=129 Participants
|
68 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Ethnicity of Participants · Not Hispanic or Latino
|
56 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
53 Participants
n=36 Participants
|
57 Participants
n=10 Participants
|
52 Participants
n=115 Participants
|
53 Participants
n=40 Participants
|
56 Participants
n=8 Participants
|
55 Participants
n=62 Participants
|
54 Participants
n=95 Participants
|
55 Participants
n=129 Participants
|
652 Participants
n=36 Participants
|
|
Body Mass Index (BMI) (kg/m^2)
|
26.637 kg/m^2
STANDARD_DEVIATION 4.4123 • n=93 Participants
|
26.750 kg/m^2
STANDARD_DEVIATION 5.3287 • n=4 Participants
|
27.561 kg/m^2
STANDARD_DEVIATION 5.1079 • n=27 Participants
|
26.840 kg/m^2
STANDARD_DEVIATION 4.4868 • n=483 Participants
|
26.458 kg/m^2
STANDARD_DEVIATION 4.4476 • n=36 Participants
|
26.495 kg/m^2
STANDARD_DEVIATION 4.2461 • n=10 Participants
|
26.798 kg/m^2
STANDARD_DEVIATION 4.6794 • n=115 Participants
|
27.297 kg/m^2
STANDARD_DEVIATION 4.5460 • n=40 Participants
|
26.457 kg/m^2
STANDARD_DEVIATION 4.7881 • n=8 Participants
|
26.824 kg/m^2
STANDARD_DEVIATION 3.9945 • n=62 Participants
|
26.867 kg/m^2
STANDARD_DEVIATION 4.0300 • n=95 Participants
|
26.268 kg/m^2
STANDARD_DEVIATION 4.7620 • n=129 Participants
|
26.771 kg/m^2
STANDARD_DEVIATION 4.5691 • n=36 Participants
|
PRIMARY outcome
Timeframe: 8 days post-vaccinationPopulation: If a subject experienced multiple occurrences of the same solicited local AE, only the most severe solicited local AE was counted. If a subject had multiple AEs the number of events analyzed may be greater than the overall number of participants analyzed. Subjects in A-D and G-J did not receive 3 doses
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses
Outcome measures
| Measure |
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=60 Participants
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=58 Participants
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=61 Participants
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
n=60 Participants
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=59 Participants
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=62 Participants
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=59 Participants
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=60 Participants
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=61 Participants
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
n=59 Participants
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=61 Participants
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=60 Participants
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received Dose 1 : Mild
|
43 Events
|
32 Events
|
35 Events
|
37 Events
|
28 Events
|
35 Events
|
18 Events
|
21 Events
|
22 Events
|
27 Events
|
25 Events
|
22 Events
|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received Dose 1 : Moderate
|
3 Events
|
5 Events
|
6 Events
|
4 Events
|
3 Events
|
10 Events
|
1 Events
|
0 Events
|
1 Events
|
2 Events
|
2 Events
|
1 Events
|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received Dose 1 : Severe
|
0 Events
|
0 Events
|
1 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received Dose 2 : Mild
|
27 Events
|
28 Events
|
27 Events
|
23 Events
|
23 Events
|
33 Events
|
16 Events
|
17 Events
|
16 Events
|
18 Events
|
16 Events
|
15 Events
|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received Dose 2 : Moderate
|
5 Events
|
4 Events
|
3 Events
|
3 Events
|
5 Events
|
3 Events
|
0 Events
|
0 Events
|
4 Events
|
2 Events
|
2 Events
|
3 Events
|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received Dose 2 : Severe
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in Subjects who received Dose 3 : Mild
|
—
|
—
|
—
|
—
|
17 Events
|
17 Events
|
—
|
—
|
—
|
—
|
10 Events
|
6 Events
|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in Subjects who received Dose 3 : Moderate
|
—
|
—
|
—
|
—
|
5 Events
|
3 Events
|
—
|
—
|
—
|
—
|
1 Events
|
0 Events
|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in Subjects who received Dose 3 : Severe
|
—
|
—
|
—
|
—
|
0 Events
|
0 Events
|
—
|
—
|
—
|
—
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: 8 days post-vaccinationPopulation: If a subject experienced multiple occurrences of the same solicited local AE, only the most severe solicited local AE was counted. Number Analyzed per Row = Participants with available data Subjects in A-D and G-J did not receive 3 doses
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses
Outcome measures
| Measure |
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=60 Participants
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=58 Participants
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=61 Participants
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
n=60 Participants
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=59 Participants
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=62 Participants
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=59 Participants
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=60 Participants
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=61 Participants
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
n=59 Participants
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=61 Participants
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=60 Participants
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 1 : Mild
|
45 Events
|
41 Events
|
32 Events
|
43 Events
|
23 Events
|
37 Events
|
29 Events
|
28 Events
|
29 Events
|
21 Events
|
32 Events
|
23 Events
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 2 : Severe
|
0 Events
|
0 Events
|
6 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 1 : Severe
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 1 : Moderate
|
6 Events
|
12 Events
|
8 Events
|
19 Events
|
6 Events
|
19 Events
|
13 Events
|
2 Events
|
6 Events
|
6 Events
|
5 Events
|
19 Events
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 2 : Mild
|
39 Events
|
33 Events
|
22 Events
|
46 Events
|
17 Events
|
40 Events
|
16 Events
|
6 Events
|
24 Events
|
4 Events
|
17 Events
|
11 Events
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 2 : Moderate
|
19 Events
|
10 Events
|
7 Events
|
20 Events
|
8 Events
|
21 Events
|
4 Events
|
0 Events
|
3 Events
|
6 Events
|
6 Events
|
2 Events
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 3 : Mild
|
—
|
—
|
—
|
—
|
19 Events
|
32 Events
|
—
|
—
|
—
|
—
|
11 Events
|
9 Events
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 3 : Moderate
|
—
|
—
|
—
|
—
|
19 Events
|
12 Events
|
—
|
—
|
—
|
—
|
2 Events
|
0 Events
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
AEs in subjects who received dose 3 : Severe
|
—
|
—
|
—
|
—
|
1 Events
|
1 Events
|
—
|
—
|
—
|
—
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: Day 43Population: Seroprotection Rate by Strain (with 95% confidence interval) of HAI antibodies at Day 43 (21 days after Dose 2)
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
Outcome measures
| Measure |
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=53 Participants
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=52 Participants
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=54 Participants
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
n=52 Participants
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=40 Participants
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=45 Participants
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=51 Participants
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=52 Participants
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=51 Participants
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
n=51 Participants
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=46 Participants
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=38 Participants
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
A/Indonesia/05/2005 (H5N1) (IN)
|
13.2 percentage of participants
Interval 4.1 to 22.3
|
38.5 percentage of participants
Interval 25.0 to 51.7
|
11.1 percentage of participants
Interval 2.7 to 19.5
|
46.2 percentage of participants
Interval 32.6 to 59.7
|
32.5 percentage of participants
Interval 18.0 to 47.0
|
4.4 percentage of participants
Interval 0.0 to 10.5
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
17.3 percentage of participants
Interval 7.0 to 27.6
|
3.9 percentage of participants
Interval 0.0 to 9.2
|
13.7 percentage of participants
Interval 4.3 to 23.2
|
10.9 percentage of participants
Interval 1.9 to 19.9
|
5.3 percentage of participants
Interval 0.0 to 12.4
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
A/barheaded goose/QinghaiLake/1A/2005(H5N1)bhg/QL
|
28.3 percentage of participants
Interval 16.2 to 40.4
|
19.2 percentage of participants
Interval 8.5 to 29.9
|
20.4 percentage of participants
Interval 9.6 to 31.1
|
34.6 percentage of participants
Interval 21.7 to 47.5
|
22.5 percentage of participants
Interval 9.6 to 35.4
|
2.2 percentage of participants
Interval 0.0 to 6.5
|
13.7 percentage of participants
Interval 4.3 to 23.2
|
13.5 percentage of participants
Interval 4.2 to 22.7
|
9.8 percentage of participants
Interval 1.6 to 18.0
|
3.9 percentage of participants
Interval 0.0 to 9.2
|
6.5 percentage of participants
Interval 0.0 to 13.7
|
2.6 percentage of participants
Interval 0.0 to 7.7
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
A/gyrfalcon/Washington/41088-6/2014 (H5N8) (gf/WA)
|
47.2 percentage of participants
Interval 33.7 to 60.6
|
40.4 percentage of participants
Interval 27.0 to 53.7
|
38.9 percentage of participants
Interval 25.9 to 51.9
|
50.0 percentage of participants
Interval 36.4 to 63.6
|
12.5 percentage of participants
Interval 2.3 to 22.7
|
80.0 percentage of participants
Interval 68.3 to 91.7
|
15.7 percentage of participants
Interval 5.7 to 25.7
|
15.4 percentage of participants
Interval 5.6 to 25.2
|
37.3 percentage of participants
Interval 24.0 to 50.5
|
11.8 percentage of participants
Interval 2.9 to 20.6
|
6.5 percentage of participants
Interval 0.0 to 13.7
|
63.2 percentage of participants
Interval 47.8 to 78.5
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
A/duck/Bangladesh/19097/2013 (H5N1) (dk/BANG)
|
26.4 percentage of participants
Interval 14.5 to 38.3
|
25.0 percentage of participants
Interval 13.2 to 36.8
|
31.5 percentage of participants
Interval 19.1 to 43.9
|
32.7 percentage of participants
Interval 19.9 to 45.4
|
67.5 percentage of participants
Interval 53.0 to 82.0
|
15.6 percentage of participants
Interval 5.0 to 26.1
|
3.9 percentage of participants
Interval 0.0 to 9.2
|
9.6 percentage of participants
Interval 1.6 to 17.6
|
33.3 percentage of participants
Interval 20.4 to 46.3
|
13.7 percentage of participants
Interval 4.3 to 23.2
|
50.0 percentage of participants
Interval 35.6 to 64.4
|
13.2 percentage of participants
Interval 2.4 to 23.9
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
A/Vietnam/1203/2004 (H5N1) (VN)
|
75.5 percentage of participants
Interval 63.9 to 87.1
|
55.8 percentage of participants
Interval 42.3 to 69.3
|
44.4 percentage of participants
Interval 31.2 to 57.7
|
65.4 percentage of participants
Interval 52.5 to 78.3
|
37.5 percentage of participants
Interval 22.5 to 52.5
|
17.8 percentage of participants
Interval 6.6 to 28.9
|
39.2 percentage of participants
Interval 25.8 to 52.6
|
23.1 percentage of participants
Interval 11.6 to 34.5
|
33.3 percentage of participants
Interval 20.4 to 46.3
|
37.3 percentage of participants
Interval 24.0 to 50.5
|
26.1 percentage of participants
Interval 13.4 to 38.8
|
18.4 percentage of participants
Interval 6.1 to 30.7
|
PRIMARY outcome
Timeframe: Day 163Population: Seroprotection Rate by Strain (with 95% confidence interval) of HAI antibodies at Day 163 (21 days after Dose 3). Measurement of participants remaining rather than enrolled.
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
Outcome measures
| Measure |
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=40 Participants
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=45 Participants
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=46 Participants
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
n=38 Participants
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
A/gyrfalcon/Washington/41088-6/2014 (H5N8) (gf/WA)
|
60.0 percentage of participants
Interval 44.8 to 75.2
|
82.2 percentage of participants
Interval 71.1 to 93.4
|
28.3 percentage of participants
Interval 15.2 to 41.4
|
52.6 percentage of participants
Interval 36.8 to 68.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
A/Indonesia/05/2005 (H5N1) (IN)
|
75.0 percentage of participants
Interval 61.6 to 88.4
|
57.8 percentage of participants
Interval 43.3 to 72.2
|
50.0 percentage of participants
Interval 35.6 to 64.4
|
15.8 percentage of participants
Interval 4.2 to 27.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
A/Vietnam/1203/2004 (H5N1) (VN)
|
90.0 percentage of participants
Interval 80.7 to 99.3
|
80.0 percentage of participants
Interval 68.3 to 91.7
|
63.0 percentage of participants
Interval 49.1 to 77.0
|
60.5 percentage of participants
Interval 45.0 to 76.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
A/duck/Bangladesh/19097/2013 (H5N1) (dk/BANG)
|
90.0 percentage of participants
Interval 80.7 to 99.3
|
62.2 percentage of participants
Interval 48.1 to 76.4
|
63.0 percentage of participants
Interval 49.1 to 77.0
|
26.3 percentage of participants
Interval 12.3 to 40.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
A/barheaded goose/QinghaiLake/1A/2005(H5N1)bhg/QL
|
72.5 percentage of participants
Interval 58.7 to 86.3
|
73.3 percentage of participants
Interval 60.4 to 86.3
|
45.7 percentage of participants
Interval 31.2 to 60.0
|
39.5 percentage of participants
Interval 23.9 to 55.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
Serious events: 2 serious events
Other events: 47 other events
Deaths: 1 deaths
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
Serious events: 4 serious events
Other events: 45 other events
Deaths: 0 deaths
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=60 participants at risk
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=58 participants at risk
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=61 participants at risk
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
n=60 participants at risk
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=59 participants at risk
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=62 participants at risk
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=59 participants at risk
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=60 participants at risk
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=61 participants at risk
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
n=59 participants at risk
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=61 participants at risk
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=60 participants at risk
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Angioedema
|
1.7%
1/60 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/59 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Infections and infestations
Acute Appendicitis
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/59 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Psychiatric disorders
Major Depressive Episode with Suicidal Intent
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with Spontaneous Abortion
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Cardiac disorders
Extrasystoles/Ventricluar Premature Contractions
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/60 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/58 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Congenital, familial and genetic disorders
Ankyloglossia, congenital
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/58 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Psychiatric disorders
Major depression
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/59 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/59 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Infections and infestations
Bartholin's Abscess
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/60 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
Other adverse events
| Measure |
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=60 participants at risk
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=58 participants at risk
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant
n=61 participants at risk
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant
n=60 participants at risk
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=59 participants at risk
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant
n=62 participants at risk
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=59 participants at risk
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=60 participants at risk
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant
n=61 participants at risk
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant
n=59 participants at risk
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=61 participants at risk
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
n=60 participants at risk
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
70.0%
42/60 • Number of events 42 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
60.3%
35/58 • Number of events 35 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
59.0%
36/61 • Number of events 36 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
58.3%
35/60 • Number of events 35 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
59.3%
35/59 • Number of events 35 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
58.1%
36/62 • Number of events 36 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
37.3%
22/59 • Number of events 22 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
43.3%
26/60 • Number of events 26 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
41.0%
25/61 • Number of events 25 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
47.5%
28/59 • Number of events 28 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
54.1%
33/61 • Number of events 33 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
41.7%
25/60 • Number of events 25 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
General disorders
Fatigue
|
25.0%
15/60 • Number of events 15 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
24.1%
14/58 • Number of events 14 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
19.7%
12/61 • Number of events 12 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
23.3%
14/60 • Number of events 14 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
15.3%
9/59 • Number of events 9 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
25.8%
16/62 • Number of events 16 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
11.9%
7/59 • Number of events 7 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
10.0%
6/60 • Number of events 6 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
19.7%
12/61 • Number of events 12 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
13.6%
8/59 • Number of events 8 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.4%
10/61 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
10.0%
6/60 • Number of events 6 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
General disorders
Chills
|
16.7%
10/60 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
12.1%
7/58 • Number of events 7 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
9.8%
6/61 • Number of events 6 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
20.0%
12/60 • Number of events 12 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
11.9%
7/59 • Number of events 7 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
22.6%
14/62 • Number of events 14 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.8%
4/59 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.4%
2/59 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.3%
2/61 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
General disorders
Injection site swelling
|
8.3%
5/60 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.4%
2/58 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
9.8%
6/61 • Number of events 6 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.5%
5/59 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.1%
10/62 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
General disorders
Injection site erythema
|
8.3%
5/60 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.9%
4/58 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.2%
5/61 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.3%
2/60 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.1%
3/59 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.5%
4/62 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/59 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/60 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/59 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
General disorders
Pyrexia
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/58 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.7%
4/60 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.8%
4/59 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.5%
4/62 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
General disorders
Injection site bruising
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.4%
2/59 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Nervous system disorders
Headache
|
35.0%
21/60 • Number of events 21 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
27.6%
16/58 • Number of events 16 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
13.1%
8/61 • Number of events 8 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
28.3%
17/60 • Number of events 17 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.9%
10/59 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
35.5%
22/62 • Number of events 22 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.9%
10/59 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
18.3%
11/60 • Number of events 11 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
19.7%
12/61 • Number of events 12 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
11.9%
7/59 • Number of events 7 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
29.5%
18/61 • Number of events 18 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
18.3%
11/60 • Number of events 11 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Nervous system disorders
Dizziness
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.4%
2/58 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.3%
2/61 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/62 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.3%
17/60 • Number of events 17 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
22.4%
13/58 • Number of events 13 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
23.0%
14/61 • Number of events 14 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
33.3%
20/60 • Number of events 20 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
22.0%
13/59 • Number of events 13 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
41.9%
26/62 • Number of events 26 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
13.6%
8/59 • Number of events 8 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.7%
4/60 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
23.0%
14/61 • Number of events 14 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.5%
5/59 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
18.0%
11/61 • Number of events 11 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.7%
10/60 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
4/60 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.9%
4/58 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.6%
4/61 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.7%
4/60 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.8%
4/59 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.1%
10/62 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.4%
2/59 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
4.9%
3/61 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.1%
3/59 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.6%
4/61 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.0%
3/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Gastrointestinal disorders
Nausea
|
15.0%
9/60 • Number of events 9 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
10.3%
6/58 • Number of events 6 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
11.5%
7/61 • Number of events 7 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.7%
10/60 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.9%
10/59 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
16.1%
10/62 • Number of events 10 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.5%
5/59 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
4.9%
3/61 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.1%
3/59 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.2%
5/61 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
10.0%
6/60 • Number of events 6 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
4/60 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.6%
5/58 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.2%
5/61 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
11.7%
7/60 • Number of events 7 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
15.3%
9/59 • Number of events 9 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
14.5%
9/62 • Number of events 9 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
11.9%
7/59 • Number of events 7 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.2%
5/61 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.5%
5/59 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
11.5%
7/61 • Number of events 7 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
8.3%
5/60 • Number of events 5 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.2%
3/58 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
4.9%
3/61 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.3%
2/60 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.4%
2/59 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/62 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.4%
2/58 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.0%
3/60 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.8%
4/59 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.5%
4/62 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
3.3%
2/60 • Number of events 2 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.7%
1/59 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
1.6%
1/61 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
6.7%
4/60 • Number of events 4 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia
|
1.7%
1/60 • Number of events 1 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/58 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
5.1%
3/59 • Number of events 3 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/62 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/59 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/61 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
0.00%
0/60 • 262 days
Adverse events (AE) - If a subject experienced multiple occurrences of the same AE, only the most severe AE was counted
|
Additional Information
Silvija Tresnjak-Smith, Regulatory Operations Branch Chief, Regulatory and Quality Affairs Division
BARDA
Phone: 202-557-1993
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place