Trial Outcomes & Findings for Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59 (NCT NCT06560151)
NCT ID: NCT06560151
Last Updated: 2026-07-23
Results Overview
The percentage of participants who experienced at least one solicited local reactogenicity adverse event at the injection site during at least one of the time frames specified. Possible reactions included erythema/redness, induration (underlying hardening of tissue associated with inflammation)/swelling (localized tissue distention), and pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1380 participants
Primary outcome timeframe
Day 1 through Day 8 and Day 22 through Day 29
Results posted on
2026-07-23
Participant Flow
Twenty clinical sites in the United States screened and enrolled participants into the trial.
Potential participants signed an informed consent before undergoing any study procedures. After the informed consent was signed and the participant was determined to meet entry criteria, the participant was enrolled in the study.
Participant milestones
| Measure |
3.75 µg H5N8 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
3.75 µg H5N8 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N8 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
121
|
121
|
60
|
119
|
120
|
60
|
120
|
119
|
60
|
118
|
59
|
60
|
121
|
61
|
|
Overall Study
COMPLETED
|
55
|
110
|
108
|
53
|
110
|
110
|
55
|
112
|
109
|
55
|
112
|
58
|
55
|
113
|
58
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
13
|
7
|
9
|
10
|
5
|
8
|
10
|
5
|
6
|
1
|
5
|
8
|
3
|
Reasons for withdrawal
| Measure |
3.75 µg H5N8 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
3.75 µg H5N8 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N8 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
10
|
5
|
6
|
6
|
2
|
5
|
5
|
3
|
3
|
1
|
4
|
7
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
3
|
0
|
3
|
4
|
3
|
3
|
5
|
1
|
3
|
0
|
1
|
0
|
1
|
|
Overall Study
Non-compliance with study schedule
|
1
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject incarcerated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59
Baseline characteristics by cohort
| Measure |
3.75 µg H5N8 Plus AS03A Full Dose
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
3.75 µg H5N8 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N8 Plus MF59
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus MF59
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
Total
n=1380 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=9 Participants
|
61 Participants
n=27 Participants
|
60 Participants
n=267 Participants
|
59 Participants
n=265 Participants
|
60 Participants
n=568 Participants
|
60 Participants
n=22 Participants
|
60 Participants
n=23 Participants
|
60 Participants
n=22 Participants
|
59 Participants
n=178 Participants
|
60 Participants
n=116 Participants
|
58 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
59 Participants
n=190 Participants
|
60 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
777 Participants
n=18 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
60 Participants
n=27 Participants
|
60 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
59 Participants
n=568 Participants
|
60 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
60 Participants
n=22 Participants
|
60 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
60 Participants
n=2 Participants
|
59 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
61 Participants
n=19 Participants
|
61 Participants
n=18 Participants
|
600 Participants
n=18 Participants
|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 11.81 • n=9 Participants
|
58.7 years
STANDARD_DEVIATION 16.59 • n=27 Participants
|
57.4 years
STANDARD_DEVIATION 17.02 • n=267 Participants
|
47.5 years
STANDARD_DEVIATION 11.76 • n=265 Participants
|
59.0 years
STANDARD_DEVIATION 16.79 • n=568 Participants
|
57.8 years
STANDARD_DEVIATION 17.41 • n=22 Participants
|
42.6 years
STANDARD_DEVIATION 13.13 • n=23 Participants
|
60.5 years
STANDARD_DEVIATION 16.34 • n=22 Participants
|
59.6 years
STANDARD_DEVIATION 15.74 • n=178 Participants
|
43.0 years
STANDARD_DEVIATION 12.95 • n=116 Participants
|
59.2 years
STANDARD_DEVIATION 14.92 • n=2 Participants
|
71.4 years
STANDARD_DEVIATION 4.62 • n=4 Participants
|
46.1 years
STANDARD_DEVIATION 12.80 • n=190 Participants
|
58.9 years
STANDARD_DEVIATION 16.34 • n=19 Participants
|
71.2 years
STANDARD_DEVIATION 4.80 • n=18 Participants
|
57.0 years
STANDARD_DEVIATION 16.53 • n=18 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=9 Participants
|
58 Participants
n=27 Participants
|
62 Participants
n=267 Participants
|
34 Participants
n=265 Participants
|
68 Participants
n=568 Participants
|
62 Participants
n=22 Participants
|
27 Participants
n=23 Participants
|
62 Participants
n=22 Participants
|
63 Participants
n=178 Participants
|
33 Participants
n=116 Participants
|
61 Participants
n=2 Participants
|
33 Participants
n=4 Participants
|
36 Participants
n=190 Participants
|
67 Participants
n=19 Participants
|
33 Participants
n=18 Participants
|
736 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=9 Participants
|
63 Participants
n=27 Participants
|
59 Participants
n=267 Participants
|
26 Participants
n=265 Participants
|
51 Participants
n=568 Participants
|
58 Participants
n=22 Participants
|
33 Participants
n=23 Participants
|
58 Participants
n=22 Participants
|
56 Participants
n=178 Participants
|
27 Participants
n=116 Participants
|
57 Participants
n=2 Participants
|
26 Participants
n=4 Participants
|
24 Participants
n=190 Participants
|
54 Participants
n=19 Participants
|
28 Participants
n=18 Participants
|
644 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
9 Participants
n=568 Participants
|
10 Participants
n=22 Participants
|
11 Participants
n=23 Participants
|
15 Participants
n=22 Participants
|
9 Participants
n=178 Participants
|
4 Participants
n=116 Participants
|
6 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=190 Participants
|
8 Participants
n=19 Participants
|
4 Participants
n=18 Participants
|
117 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=9 Participants
|
109 Participants
n=27 Participants
|
111 Participants
n=267 Participants
|
51 Participants
n=265 Participants
|
107 Participants
n=568 Participants
|
107 Participants
n=22 Participants
|
47 Participants
n=23 Participants
|
102 Participants
n=22 Participants
|
106 Participants
n=178 Participants
|
55 Participants
n=116 Participants
|
110 Participants
n=2 Participants
|
59 Participants
n=4 Participants
|
53 Participants
n=190 Participants
|
112 Participants
n=19 Participants
|
55 Participants
n=18 Participants
|
1236 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=22 Participants
|
4 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=190 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=18 Participants
|
27 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
5 Participants
n=22 Participants
|
3 Participants
n=23 Participants
|
4 Participants
n=22 Participants
|
2 Participants
n=178 Participants
|
3 Participants
n=116 Participants
|
4 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=190 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
32 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
18 Participants
n=568 Participants
|
18 Participants
n=22 Participants
|
11 Participants
n=23 Participants
|
23 Participants
n=22 Participants
|
21 Participants
n=178 Participants
|
17 Participants
n=116 Participants
|
13 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=190 Participants
|
18 Participants
n=19 Participants
|
9 Participants
n=18 Participants
|
240 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=9 Participants
|
88 Participants
n=27 Participants
|
93 Participants
n=267 Participants
|
44 Participants
n=265 Participants
|
94 Participants
n=568 Participants
|
92 Participants
n=22 Participants
|
44 Participants
n=23 Participants
|
91 Participants
n=22 Participants
|
94 Participants
n=178 Participants
|
37 Participants
n=116 Participants
|
98 Participants
n=2 Participants
|
53 Participants
n=4 Participants
|
44 Participants
n=190 Participants
|
100 Participants
n=19 Participants
|
52 Participants
n=18 Participants
|
1067 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
22 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=9 Participants
|
121 participants
n=27 Participants
|
121 participants
n=267 Participants
|
60 participants
n=265 Participants
|
119 participants
n=568 Participants
|
120 participants
n=22 Participants
|
60 participants
n=23 Participants
|
120 participants
n=22 Participants
|
119 participants
n=178 Participants
|
60 participants
n=116 Participants
|
118 participants
n=2 Participants
|
59 participants
n=4 Participants
|
60 participants
n=190 Participants
|
121 participants
n=19 Participants
|
61 participants
n=18 Participants
|
1380 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8 and Day 22 through Day 29Population: The safety population included all participants who were randomized and received at least one vaccination.
The percentage of participants who experienced at least one solicited local reactogenicity adverse event at the injection site during at least one of the time frames specified. Possible reactions included erythema/redness, induration (underlying hardening of tissue associated with inflammation)/swelling (localized tissue distention), and pain.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
18-64 years
|
38.3 Percentage of Participants
Interval 26.1 to 51.8
|
28.8 Percentage of Participants
Interval 17.8 to 42.1
|
48.3 Percentage of Participants
Interval 35.2 to 61.6
|
72.4 Percentage of Participants
Interval 59.1 to 83.3
|
35.0 Percentage of Participants
Interval 23.1 to 48.4
|
61.7 Percentage of Participants
Interval 48.2 to 73.9
|
62.3 Percentage of Participants
Interval 49.0 to 74.4
|
59.0 Percentage of Participants
Interval 45.7 to 71.4
|
67.2 Percentage of Participants
Interval 54.0 to 78.7
|
43.3 Percentage of Participants
Interval 30.6 to 56.8
|
60.0 Percentage of Participants
Interval 46.5 to 72.4
|
60.0 Percentage of Participants
Interval 46.5 to 72.4
|
—
|
33.3 Percentage of Participants
Interval 21.7 to 46.7
|
—
|
|
The Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
>65 years
|
20.0 Percentage of Participants
Interval 10.8 to 32.3
|
23.3 Percentage of Participants
Interval 13.4 to 36.0
|
—
|
46.7 Percentage of Participants
Interval 33.7 to 60.0
|
18.0 Percentage of Participants
Interval 9.4 to 30.0
|
—
|
—
|
38.3 Percentage of Participants
Interval 26.1 to 51.8
|
30.0 Percentage of Participants
Interval 18.8 to 43.2
|
—
|
45.8 Percentage of Participants
Interval 32.7 to 59.2
|
41.7 Percentage of Participants
Interval 29.1 to 55.1
|
47.5 Percentage of Participants
Interval 34.3 to 60.9
|
—
|
36.1 Percentage of Participants
Interval 24.2 to 49.4
|
|
The Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
Overall
|
29.2 Percentage of Participants
Interval 21.2 to 38.2
|
26.1 Percentage of Participants
Interval 18.4 to 34.9
|
48.3 Percentage of Participants
Interval 35.2 to 61.6
|
59.3 Percentage of Participants
Interval 49.9 to 68.3
|
26.4 Percentage of Participants
Interval 18.8 to 35.2
|
61.7 Percentage of Participants
Interval 48.2 to 73.9
|
62.3 Percentage of Participants
Interval 49.0 to 74.4
|
48.8 Percentage of Participants
Interval 39.6 to 58.0
|
48.8 Percentage of Participants
Interval 39.6 to 58.0
|
43.3 Percentage of Participants
Interval 30.6 to 56.8
|
52.9 Percentage of Participants
Interval 43.6 to 62.2
|
50.8 Percentage of Participants
Interval 41.6 to 60.1
|
47.5 Percentage of Participants
Interval 34.3 to 60.9
|
33.3 Percentage of Participants
Interval 21.7 to 46.7
|
36.1 Percentage of Participants
Interval 24.2 to 49.4
|
PRIMARY outcome
Timeframe: Day 1 through Day 8 and Day 22 through Day 29Population: The safety population included all participants who were randomized and received at least one vaccination.
The percentage of participants who experienced at least one solicited systemic reactogenicity adverse event during at least one of the time frames specified. Possible reactions included fever, myalgia, arthralgia, fatigue, headache, nausea, vomiting, diarrhea, and chills.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Who Experience Any Solicited Systemic Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
18-64 years
|
41.7 Percentage of Participants
Interval 29.1 to 55.1
|
18.6 Percentage of Participants
Interval 9.7 to 30.9
|
48.3 Percentage of Participants
Interval 35.2 to 61.6
|
51.7 Percentage of Participants
Interval 38.2 to 65.0
|
38.3 Percentage of Participants
Interval 26.1 to 51.8
|
48.3 Percentage of Participants
Interval 35.2 to 61.6
|
50.8 Percentage of Participants
Interval 37.7 to 63.9
|
52.5 Percentage of Participants
Interval 39.3 to 65.4
|
55.7 Percentage of Participants
Interval 42.4 to 68.5
|
35.0 Percentage of Participants
Interval 23.1 to 48.4
|
38.3 Percentage of Participants
Interval 26.1 to 51.8
|
48.3 Percentage of Participants
Interval 35.2 to 61.6
|
—
|
30.0 Percentage of Participants
Interval 18.8 to 43.2
|
—
|
|
The Percentage of Participants Who Experience Any Solicited Systemic Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
>65 years
|
23.3 Percentage of Participants
Interval 13.4 to 36.0
|
23.3 Percentage of Participants
Interval 13.4 to 36.0
|
—
|
33.3 Percentage of Participants
Interval 21.7 to 46.7
|
21.3 Percentage of Participants
Interval 11.9 to 33.7
|
—
|
—
|
41.7 Percentage of Participants
Interval 29.1 to 55.1
|
28.3 Percentage of Participants
Interval 17.5 to 41.4
|
—
|
35.6 Percentage of Participants
Interval 23.6 to 49.1
|
38.3 Percentage of Participants
Interval 26.1 to 51.8
|
32.2 Percentage of Participants
Interval 20.6 to 45.6
|
—
|
18.0 Percentage of Participants
Interval 9.4 to 30.0
|
|
The Percentage of Participants Who Experience Any Solicited Systemic Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
Overall
|
32.5 Percentage of Participants
Interval 24.2 to 41.7
|
21.0 Percentage of Participants
Interval 14.1 to 29.4
|
48.3 Percentage of Participants
Interval 35.2 to 61.6
|
42.4 Percentage of Participants
Interval 33.3 to 51.8
|
29.8 Percentage of Participants
Interval 21.8 to 38.7
|
48.3 Percentage of Participants
Interval 35.2 to 61.6
|
50.8 Percentage of Participants
Interval 37.7 to 63.9
|
47.1 Percentage of Participants
Interval 38.0 to 56.4
|
42.1 Percentage of Participants
Interval 33.2 to 51.5
|
35.0 Percentage of Participants
Interval 23.1 to 48.4
|
37.0 Percentage of Participants
Interval 28.3 to 46.3
|
43.3 Percentage of Participants
Interval 34.3 to 52.7
|
32.2 Percentage of Participants
Interval 20.6 to 45.6
|
30.0 Percentage of Participants
Interval 18.8 to 43.2
|
18.0 Percentage of Participants
Interval 9.4 to 30.0
|
PRIMARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate assay results at the Day 43 visit within -7/+14 days of the expected date, and had no major protocol deviations impacting immunogenicity.
The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
18-64 years
|
75.4 Percentage of Participants
Interval 62.2 to 85.9
|
66.7 Percentage of Participants
Interval 52.1 to 79.2
|
57.1 Percentage of Participants
Interval 43.2 to 70.3
|
1.9 Percentage of Participants
Interval 0.0 to 10.3
|
7.3 Percentage of Participants
Interval 2.0 to 17.6
|
8.0 Percentage of Participants
Interval 2.2 to 19.2
|
87.5 Percentage of Participants
Interval 75.9 to 94.8
|
89.8 Percentage of Participants
Interval 77.8 to 96.6
|
96.0 Percentage of Participants
Interval 86.3 to 99.5
|
87.3 Percentage of Participants
Interval 75.5 to 94.7
|
81.1 Percentage of Participants
Interval 68.0 to 90.6
|
81.1 Percentage of Participants
Interval 68.0 to 90.6
|
—
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
—
|
|
The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
> 65 years
|
52.8 Percentage of Participants
Interval 38.6 to 66.7
|
63.2 Percentage of Participants
Interval 49.3 to 75.6
|
—
|
11.9 Percentage of Participants
Interval 4.9 to 22.9
|
6.8 Percentage of Participants
Interval 1.9 to 16.5
|
—
|
—
|
86.8 Percentage of Participants
Interval 74.7 to 94.5
|
80.4 Percentage of Participants
Interval 67.6 to 89.8
|
—
|
78.0 Percentage of Participants
Interval 65.3 to 87.7
|
78.6 Percentage of Participants
Interval 65.6 to 88.4
|
20.0 Percentage of Participants
Interval 10.4 to 33.0
|
—
|
3.4 Percentage of Participants
Interval 0.4 to 11.7
|
SECONDARY outcome
Timeframe: Day 1 through Day 22 and Day 22 through Day 43Population: The safety population included all participants who were randomized and received at least one vaccination.
The percentage of participants who experienced at least one unsolicited TEAE during at least one of the time frames specified. Unsolicited TEAEs were defined as any adverse event other than those included in the lists for solicited local and systemic reactions.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Who Experience Any Unsolicited Treatment-emergent Adverse Event (TEAE) Within 22 Days of Each Vaccination, Inclusive of the Vaccination Day.
18-64 years
|
25.0 Percentage of Participants
Interval 14.7 to 37.9
|
18.6 Percentage of Participants
Interval 9.7 to 30.9
|
40.0 Percentage of Participants
Interval 27.6 to 53.5
|
17.2 Percentage of Participants
Interval 8.6 to 29.4
|
16.7 Percentage of Participants
Interval 8.3 to 28.5
|
20.0 Percentage of Participants
Interval 10.8 to 32.3
|
27.9 Percentage of Participants
Interval 17.1 to 40.8
|
23.0 Percentage of Participants
Interval 13.2 to 35.5
|
21.3 Percentage of Participants
Interval 11.9 to 33.7
|
28.3 Percentage of Participants
Interval 17.5 to 41.4
|
28.3 Percentage of Participants
Interval 17.5 to 41.4
|
18.3 Percentage of Participants
Interval 9.5 to 30.4
|
—
|
21.7 Percentage of Participants
Interval 12.1 to 34.2
|
—
|
|
The Percentage of Participants Who Experience Any Unsolicited Treatment-emergent Adverse Event (TEAE) Within 22 Days of Each Vaccination, Inclusive of the Vaccination Day.
>65 years
|
31.7 Percentage of Participants
Interval 20.3 to 45.0
|
18.3 Percentage of Participants
Interval 9.5 to 30.4
|
—
|
30.0 Percentage of Participants
Interval 18.8 to 43.2
|
36.1 Percentage of Participants
Interval 24.2 to 49.4
|
—
|
—
|
28.3 Percentage of Participants
Interval 17.5 to 41.4
|
30.0 Percentage of Participants
Interval 18.8 to 43.2
|
—
|
30.5 Percentage of Participants
Interval 19.2 to 43.9
|
25.0 Percentage of Participants
Interval 14.7 to 37.9
|
27.1 Percentage of Participants
Interval 16.4 to 40.3
|
—
|
24.6 Percentage of Participants
Interval 14.5 to 37.3
|
|
The Percentage of Participants Who Experience Any Unsolicited Treatment-emergent Adverse Event (TEAE) Within 22 Days of Each Vaccination, Inclusive of the Vaccination Day.
Overall
|
28.3 Percentage of Participants
Interval 20.5 to 37.3
|
18.5 Percentage of Participants
Interval 12.0 to 26.6
|
40.0 Percentage of Participants
Interval 27.6 to 53.5
|
23.7 Percentage of Participants
Interval 16.4 to 32.4
|
26.4 Percentage of Participants
Interval 18.8 to 35.2
|
20.0 Percentage of Participants
Interval 10.8 to 32.3
|
27.9 Percentage of Participants
Interval 17.1 to 40.8
|
25.6 Percentage of Participants
Interval 18.1 to 34.4
|
25.6 Percentage of Participants
Interval 18.1 to 34.4
|
28.3 Percentage of Participants
Interval 17.5 to 41.4
|
29.4 Percentage of Participants
Interval 21.4 to 38.5
|
21.7 Percentage of Participants
Interval 14.7 to 30.1
|
27.1 Percentage of Participants
Interval 16.4 to 40.3
|
21.7 Percentage of Participants
Interval 12.1 to 34.2
|
24.6 Percentage of Participants
Interval 14.5 to 37.3
|
SECONDARY outcome
Timeframe: Day 1 through Day 203Population: The safety population included all participants who were randomized and received at least one vaccination.
The percentage of participants who experienced at least one treatment-emergent SAE during the time frame specified.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Who Experience Any Treatment-emergent Serious Adverse Event (SAE).
18-64 years
|
3.3 Percentage of Participants
Interval 0.4 to 11.5
|
0 Percentage of Participants
Interval 0.0 to 6.1
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
3.3 Percentage of Participants
Interval 0.4 to 11.5
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
Interval 0.0 to 6.0
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
0 Percentage of Participants
Interval 0.0 to 6.0
|
—
|
0 Percentage of Participants
Interval 0.0 to 6.0
|
—
|
|
The Percentage of Participants Who Experience Any Treatment-emergent Serious Adverse Event (SAE).
>65 years
|
8.3 Percentage of Participants
Interval 2.8 to 18.4
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
—
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
—
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
—
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
|
The Percentage of Participants Who Experience Any Treatment-emergent Serious Adverse Event (SAE).
Overall
|
5.8 Percentage of Participants
Interval 2.4 to 11.6
|
0.8 Percentage of Participants
Interval 0.0 to 4.6
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
0.8 Percentage of Participants
Interval 0.0 to 4.6
|
1.7 Percentage of Participants
Interval 0.2 to 5.8
|
0 Percentage of Participants
Interval 0.0 to 6.0
|
0 Percentage of Participants
Interval 0.0 to 5.9
|
0.8 Percentage of Participants
Interval 0.0 to 4.5
|
0.8 Percentage of Participants
Interval 0.0 to 4.5
|
0 Percentage of Participants
Interval 0.0 to 6.0
|
1.7 Percentage of Participants
Interval 0.2 to 5.9
|
0.8 Percentage of Participants
Interval 0.0 to 4.6
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
0 Percentage of Participants
Interval 0.0 to 6.0
|
0 Percentage of Participants
Interval 0.0 to 5.9
|
SECONDARY outcome
Timeframe: Day 1 through Day 203Population: The safety population included all participants who were randomized and received at least one vaccination.
The percentage of participants who experienced at least one treatment-emergent MAAE during the time frame specified. MAAEs were defined as adverse events with medically attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Who Experience Any Treatment-emergent Medically Attended Adverse Events (MAAE).
18-64 years
|
11.7 Percentage of Participants
Interval 4.8 to 22.6
|
5.1 Percentage of Participants
Interval 1.1 to 14.1
|
16.7 Percentage of Participants
Interval 8.3 to 28.5
|
10.3 Percentage of Participants
Interval 3.9 to 21.2
|
5.0 Percentage of Participants
Interval 1.0 to 13.9
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
8.2 Percentage of Participants
Interval 2.7 to 18.1
|
3.3 Percentage of Participants
Interval 0.4 to 11.3
|
6.6 Percentage of Participants
Interval 1.8 to 15.9
|
11.7 Percentage of Participants
Interval 4.8 to 22.6
|
3.3 Percentage of Participants
Interval 0.4 to 11.5
|
6.7 Percentage of Participants
Interval 1.8 to 16.2
|
—
|
5.0 Percentage of Participants
Interval 1.0 to 13.9
|
—
|
|
The Percentage of Participants Who Experience Any Treatment-emergent Medically Attended Adverse Events (MAAE).
>65 years
|
23.3 Percentage of Participants
Interval 13.4 to 36.0
|
5.0 Percentage of Participants
Interval 1.0 to 13.9
|
—
|
8.3 Percentage of Participants
Interval 2.8 to 18.4
|
13.1 Percentage of Participants
Interval 5.8 to 24.2
|
—
|
—
|
6.7 Percentage of Participants
Interval 1.8 to 16.2
|
15.0 Percentage of Participants
Interval 7.1 to 26.6
|
—
|
8.5 Percentage of Participants
Interval 2.8 to 18.7
|
13.3 Percentage of Participants
Interval 5.9 to 24.6
|
11.9 Percentage of Participants
Interval 4.9 to 22.9
|
—
|
3.3 Percentage of Participants
Interval 0.4 to 11.3
|
|
The Percentage of Participants Who Experience Any Treatment-emergent Medically Attended Adverse Events (MAAE).
Overall
|
17.5 Percentage of Participants
Interval 11.2 to 25.5
|
5.0 Percentage of Participants
Interval 1.9 to 10.7
|
16.7 Percentage of Participants
Interval 8.3 to 28.5
|
9.3 Percentage of Participants
Interval 4.7 to 16.1
|
9.1 Percentage of Participants
Interval 4.6 to 15.7
|
1.7 Percentage of Participants
Interval 0.0 to 8.9
|
8.2 Percentage of Participants
Interval 2.7 to 18.1
|
5.0 Percentage of Participants
Interval 1.8 to 10.5
|
10.7 Percentage of Participants
Interval 5.8 to 17.7
|
11.7 Percentage of Participants
Interval 4.8 to 22.6
|
5.9 Percentage of Participants
Interval 2.4 to 11.7
|
10.0 Percentage of Participants
Interval 5.3 to 16.8
|
11.9 Percentage of Participants
Interval 4.9 to 22.9
|
5.0 Percentage of Participants
Interval 1.0 to 13.9
|
3.3 Percentage of Participants
Interval 0.4 to 11.3
|
SECONDARY outcome
Timeframe: Day 1 through Day 203Population: The safety population included all participants who were randomized and received at least one vaccination.
The percentage of participants who experienced at least one treatment-emergent pIMD during the time frame specified. A comprehensive list of adverse events to be reported as pIMDs is available in Appendix 3 of the Protocol.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=120 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Who Experience Any Treatment-emergent Potentially Immune-mediated Disease (pIMD).
18-64 years
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
|
The Percentage of Participants Who Experience Any Treatment-emergent Potentially Immune-mediated Disease (pIMD).
>65 Years
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
|
The Percentage of Participants Who Experience Any Treatment-emergent Potentially Immune-mediated Disease (pIMD).
Overall
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events.
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate assay results at the Day 43 visit within -7/+14 days of the expected date, and had no major protocol deviations impacting immunogenicity.
The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
18-64 years
|
7.0 Percentage of Participants
Interval 1.9 to 17.0
|
5.9 Percentage of Participants
Interval 1.2 to 16.2
|
8.9 Percentage of Participants
Interval 3.0 to 19.6
|
86.5 Percentage of Participants
Interval 74.2 to 94.4
|
65.5 Percentage of Participants
Interval 51.4 to 77.8
|
84.0 Percentage of Participants
Interval 70.9 to 92.8
|
8.9 Percentage of Participants
Interval 3.0 to 19.6
|
16.3 Percentage of Participants
Interval 7.3 to 29.7
|
8.0 Percentage of Participants
Interval 2.2 to 19.2
|
3.6 Percentage of Participants
Interval 0.4 to 12.5
|
5.7 Percentage of Participants
Interval 1.2 to 15.7
|
22.6 Percentage of Participants
Interval 12.3 to 36.2
|
—
|
59.2 Percentage of Participants
Interval 44.2 to 73.0
|
—
|
|
The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
>65 years
|
7.5 Percentage of Participants
Interval 2.1 to 18.2
|
8.8 Percentage of Participants
Interval 2.9 to 19.3
|
—
|
83.1 Percentage of Participants
Interval 71.0 to 91.6
|
35.6 Percentage of Participants
Interval 23.6 to 49.1
|
—
|
—
|
11.3 Percentage of Participants
Interval 4.3 to 23.0
|
12.5 Percentage of Participants
Interval 5.2 to 24.1
|
—
|
18.6 Percentage of Participants
Interval 9.7 to 30.9
|
17.9 Percentage of Participants
Interval 8.9 to 30.4
|
74.5 Percentage of Participants
Interval 61.0 to 85.3
|
—
|
47.5 Percentage of Participants
Interval 34.3 to 60.9
|
SECONDARY outcome
Timeframe: Screening (i.e., pre-vaccination)Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Screening.
Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Screening.
>65 years
|
5.10 Titers
Interval 4.9 to 5.3
|
5.78 Titers
Interval 4.92 to 6.8
|
—
|
6.14 Titers
Interval 4.96 to 7.6
|
6.00 Titers
Interval 5.0 to 7.19
|
—
|
—
|
5.37 Titers
Interval 4.65 to 6.21
|
5.49 Titers
Interval 4.75 to 6.34
|
—
|
5.18 Titers
Interval 4.92 to 5.46
|
5.59 Titers
Interval 4.74 to 6.59
|
5.71 Titers
Interval 4.88 to 6.67
|
—
|
5.43 Titers
Interval 5.02 to 5.87
|
|
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Screening.
18-64 years
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.50 Titers
Interval 4.7 to 6.42
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.39 Titers
Interval 4.64 to 6.25
|
5.48 Titers
Interval 4.85 to 6.2
|
5.07 Titers
Interval 4.93 to 5.21
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.97 Titers
Interval 4.65 to 7.65
|
—
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
—
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 22.
>65 years
|
21.35 Titers
Interval 14.65 to 31.11
|
26.45 Titers
Interval 17.96 to 38.96
|
—
|
8.09 Titers
Interval 6.43 to 10.19
|
6.59 Titers
Interval 5.56 to 7.81
|
—
|
—
|
56.20 Titers
Interval 37.3 to 84.67
|
49.66 Titers
Interval 33.3 to 74.06
|
—
|
43.68 Titers
Interval 28.47 to 67.02
|
40.74 Titers
Interval 27.89 to 59.52
|
8.82 Titers
Interval 6.79 to 11.44
|
—
|
8.00 Titers
Interval 6.12 to 10.46
|
|
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 22.
18-64 years
|
25.29 Titers
Interval 17.49 to 36.59
|
23.22 Titers
Interval 15.55 to 34.66
|
21.01 Titers
Interval 14.28 to 30.91
|
6.27 Titers
Interval 5.06 to 7.77
|
6.30 Titers
Interval 5.33 to 7.44
|
5.68 Titers
Interval 5.17 to 6.24
|
30.84 Titers
Interval 21.18 to 44.9
|
58.60 Titers
Interval 38.97 to 88.13
|
42.87 Titers
Interval 27.67 to 66.41
|
40.50 Titers
Interval 27.2 to 60.32
|
35.78 Titers
Interval 24.86 to 51.5
|
37.22 Titers
Interval 25.29 to 54.77
|
—
|
6.18 Titers
Interval 5.06 to 7.56
|
—
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 43.
Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 43.
>65 years
|
36.26 Titers
Interval 24.46 to 53.75
|
46.84 Titers
Interval 33.2 to 66.09
|
—
|
9.10 Titers
Interval 6.63 to 12.49
|
7.86 Titers
Interval 6.14 to 10.05
|
—
|
—
|
132.35 Titers
Interval 93.01 to 188.34
|
97.51 Titers
Interval 66.17 to 143.7
|
—
|
102.99 Titers
Interval 71.24 to 148.88
|
93.39 Titers
Interval 64.7 to 134.8
|
10.99 Titers
Interval 7.82 to 15.45
|
—
|
6.40 Titers
Interval 5.33 to 7.68
|
|
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 43.
18-64 years
|
76.65 Titers
Interval 54.45 to 107.91
|
60.96 Titers
Interval 40.53 to 91.69
|
47.57 Titers
Interval 31.41 to 72.04
|
5.83 Titers
Interval 4.98 to 6.82
|
7.21 Titers
Interval 5.37 to 9.67
|
7.17 Titers
Interval 5.67 to 9.06
|
173.40 Titers
Interval 118.24 to 254.3
|
200.63 Titers
Interval 136.41 to 295.1
|
191.60 Titers
Interval 147.68 to 248.59
|
132.44 Titers
Interval 99.21 to 176.81
|
107.37 Titers
Interval 72.05 to 160.01
|
91.77 Titers
Interval 62.93 to 133.82
|
—
|
5.56 Titers
Interval 4.74 to 6.53
|
—
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=103 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 203.
≥65 years
|
16.76 Titers
Interval 11.9 to 23.6
|
28.46 Titers
Interval 20.98 to 38.6
|
—
|
9.00 Titers
Interval 7.11 to 11.38
|
8.67 Titers
Interval 6.96 to 10.8
|
—
|
—
|
49.80 Titers
Interval 34.99 to 70.89
|
62.27 Titers
Interval 44.75 to 86.67
|
—
|
47.14 Titers
Interval 33.77 to 65.8
|
49.30 Titers
Interval 35.78 to 67.91
|
9.04 Titers
Interval 7.39 to 11.05
|
—
|
9.00 Titers
Interval 6.95 to 11.66
|
|
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 203.
18-64 years
|
31.67 Titers
Interval 23.35 to 42.94
|
28.29 Titers
Interval 20.87 to 38.34
|
23.09 Titers
Interval 16.87 to 31.6
|
7.17 Titers
Interval 5.85 to 8.79
|
5.65 Titers
Interval 5.0 to 6.38
|
5.74 Titers
Interval 5.15 to 6.39
|
59.22 Titers
Interval 42.35 to 82.79
|
70.25 Titers
Interval 48.49 to 101.76
|
67.98 Titers
Interval 47.34 to 97.62
|
47.23 Titers
Interval 34.87 to 63.97
|
45.00 Titers
Interval 31.51 to 64.26
|
48.86 Titers
Interval 34.85 to 68.48
|
—
|
5.71 Titers
Interval 5.03 to 6.48
|
—
|
SECONDARY outcome
Timeframe: Screening (i.e., pre-vaccination)Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Screening.
Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.
18-64 years
|
5.06 Titers
Interval 4.94 to 5.19
|
5.14 Titers
Interval 4.86 to 5.43
|
5.06 Titers
Interval 4.94 to 5.19
|
5.07 Titers
Interval 4.93 to 5.21
|
5.13 Titers
Interval 4.95 to 5.31
|
5.14 Titers
Interval 4.94 to 5.34
|
5.06 Titers
Interval 4.94 to 5.19
|
5.64 Titers
Interval 5.09 to 6.25
|
5.18 Titers
Interval 4.93 to 5.44
|
5.13 Titers
Interval 4.95 to 5.31
|
5.07 Titers
Interval 4.93 to 5.2
|
5.56 Titers
Interval 5.05 to 6.12
|
—
|
5.22 Titers
Interval 4.97 to 5.47
|
—
|
|
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.
≥65 years
|
5.81 Titers
Interval 4.92 to 6.87
|
5.79 Titers
Interval 5.1 to 6.56
|
—
|
7.54 Titers
Interval 6.06 to 9.38
|
6.03 Titers
Interval 5.14 to 7.08
|
—
|
—
|
5.85 Titers
Interval 5.27 to 6.49
|
6.17 Titers
Interval 4.94 to 7.7
|
—
|
5.79 Titers
Interval 5.07 to 6.61
|
6.29 Titers
Interval 5.3 to 7.46
|
6.17 Titers
Interval 5.15 to 7.39
|
—
|
6.25 Titers
Interval 5.46 to 7.15
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.
18-64 years
|
9.05 Titers
Interval 7.31 to 11.21
|
11.69 Titers
Interval 8.98 to 15.21
|
10.25 Titers
Interval 7.6 to 13.82
|
24.58 Titers
Interval 16.9 to 35.75
|
16.18 Titers
Interval 11.44 to 22.88
|
20.43 Titers
Interval 13.83 to 30.17
|
9.46 Titers
Interval 7.54 to 11.87
|
9.93 Titers
Interval 7.72 to 12.77
|
9.79 Titers
Interval 7.51 to 12.77
|
8.87 Titers
Interval 7.09 to 11.1
|
10.26 Titers
Interval 8.19 to 12.87
|
16.11 Titers
Interval 11.39 to 22.79
|
—
|
15.29 Titers
Interval 10.97 to 21.3
|
—
|
|
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.
≥65 years
|
8.06 Titers
Interval 6.22 to 10.44
|
10.06 Titers
Interval 7.8 to 12.98
|
—
|
32.95 Titers
Interval 23.08 to 47.03
|
15.72 Titers
Interval 11.22 to 22.02
|
—
|
—
|
11.85 Titers
Interval 9.2 to 15.26
|
10.12 Titers
Interval 8.17 to 12.53
|
—
|
13.02 Titers
Interval 9.71 to 17.48
|
15.80 Titers
Interval 11.58 to 21.56
|
31.68 Titers
Interval 21.09 to 47.58
|
—
|
20.83 Titers
Interval 14.65 to 29.63
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 43.
Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.
18-64 years
|
8.33 Titers
Interval 7.01 to 9.9
|
9.09 Titers
Interval 7.03 to 11.75
|
8.84 Titers
Interval 6.6 to 11.83
|
124.19 Titers
Interval 90.4 to 170.6
|
51.13 Titers
Interval 36.13 to 72.36
|
122.95 Titers
Interval 81.12 to 186.33
|
10.06 Titers
Interval 7.94 to 12.75
|
12.72 Titers
Interval 9.93 to 16.28
|
11.49 Titers
Interval 8.56 to 15.41
|
7.97 Titers
Interval 6.52 to 9.73
|
9.68 Titers
Interval 7.45 to 12.56
|
14.70 Titers
Interval 10.88 to 19.87
|
—
|
43.22 Titers
Interval 28.8 to 64.88
|
—
|
|
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.
≥65 years
|
8.27 Titers
Interval 6.36 to 10.76
|
8.59 Titers
Interval 6.89 to 10.71
|
—
|
101.78 Titers
Interval 73.42 to 141.1
|
23.30 Titers
Interval 16.34 to 33.22
|
—
|
—
|
11.10 Titers
Interval 8.71 to 14.14
|
11.04 Titers
Interval 8.56 to 14.23
|
—
|
13.33 Titers
Interval 9.82 to 18.11
|
13.79 Titers
Interval 10.26 to 18.54
|
79.49 Titers
Interval 54.35 to 116.26
|
—
|
27.62 Titers
Interval 19.47 to 39.19
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=103 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203
≥65 years
|
6.41 Titers
Interval 5.41 to 7.59
|
7.25 Titers
Interval 6.18 to 8.51
|
—
|
39.76 Titers
Interval 29.7 to 53.23
|
15.23 Titers
Interval 11.38 to 20.38
|
—
|
—
|
8.74 Titers
Interval 6.81 to 11.22
|
8.74 Titers
Interval 7.03 to 10.85
|
—
|
9.43 Titers
Interval 7.32 to 12.14
|
10.20 Titers
Interval 7.64 to 13.6
|
33.32 Titers
Interval 24.43 to 45.43
|
—
|
12.73 Titers
Interval 9.54 to 16.98
|
|
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203
18-64 years
|
6.00 Titers
Interval 5.44 to 6.62
|
6.59 Titers
Interval 5.42 to 8.0
|
6.67 Titers
Interval 5.59 to 7.95
|
36.48 Titers
Interval 27.76 to 47.95
|
13.85 Titers
Interval 10.61 to 18.07
|
30.61 Titers
Interval 22.61 to 41.46
|
8.16 Titers
Interval 6.73 to 9.89
|
7.88 Titers
Interval 6.44 to 9.64
|
7.80 Titers
Interval 6.44 to 9.45
|
6.20 Titers
Interval 5.5 to 6.98
|
6.83 Titers
Interval 5.94 to 7.85
|
8.35 Titers
Interval 6.36 to 10.97
|
—
|
14.03 Titers
Interval 10.75 to 18.32
|
—
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
18-64 years
|
37.5 Percentage of Participants
Interval 24.9 to 51.5
|
35.3 Percentage of Participants
Interval 22.4 to 49.9
|
28.6 Percentage of Participants
Interval 17.3 to 42.2
|
3.8 Percentage of Participants
Interval 0.5 to 13.2
|
3.7 Percentage of Participants
Interval 0.5 to 12.7
|
0.0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
42.9 Percentage of Participants
Interval 29.7 to 56.8
|
69.4 Percentage of Participants
Interval 54.6 to 81.7
|
54.0 Percentage of Participants
Interval 39.3 to 68.2
|
54.5 Percentage of Participants
Interval 40.6 to 68.0
|
52.8 Percentage of Participants
Interval 38.6 to 66.7
|
54.7 Percentage of Participants
Interval 40.4 to 68.4
|
—
|
6.1 Percentage of Participants
Interval 1.3 to 16.9
|
—
|
|
The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
≥65 years
|
37.7 Percentage of Participants
Interval 24.8 to 52.1
|
38.6 Percentage of Participants
Interval 26.0 to 52.4
|
—
|
8.5 Percentage of Participants
Interval 2.8 to 18.7
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
—
|
—
|
60.4 Percentage of Participants
Interval 46.0 to 73.5
|
57.1 Percentage of Participants
Interval 43.2 to 70.3
|
—
|
54.2 Percentage of Participants
Interval 40.8 to 67.3
|
53.6 Percentage of Participants
Interval 39.7 to 67.0
|
12.7 Percentage of Participants
Interval 5.3 to 24.5
|
—
|
10.2 Percentage of Participants
Interval 3.8 to 20.8
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=103 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
18-64 years
|
43.6 Percentage of Participants
Interval 30.3 to 57.7
|
38.8 Percentage of Participants
Interval 25.5 to 53.8
|
34.0 Percentage of Participants
Interval 21.5 to 48.3
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
2.0 Percentage of Participants
Interval 0.0 to 10.4
|
0.0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
64.2 Percentage of Participants
Interval 49.8 to 76.9
|
70.8 Percentage of Participants
Interval 55.9 to 83.0
|
77.6 Percentage of Participants
Interval 63.4 to 88.2
|
60.0 Percentage of Participants
Interval 45.2 to 73.6
|
60.0 Percentage of Participants
Interval 45.2 to 73.6
|
55.8 Percentage of Participants
Interval 41.3 to 69.5
|
—
|
2.1 Percentage of Participants
Interval 0.1 to 11.3
|
—
|
|
The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
≥65 years
|
28.3 Percentage of Participants
Interval 16.8 to 42.3
|
38.2 Percentage of Participants
Interval 25.4 to 52.3
|
—
|
8.5 Percentage of Participants
Interval 2.8 to 18.7
|
7.1 Percentage of Participants
Interval 2.0 to 17.3
|
—
|
—
|
63.3 Percentage of Participants
Interval 48.3 to 76.6
|
61.1 Percentage of Participants
Interval 46.9 to 74.1
|
—
|
59.3 Percentage of Participants
Interval 45.7 to 71.9
|
60.4 Percentage of Participants
Interval 46.0 to 73.5
|
5.5 Percentage of Participants
Interval 1.1 to 15.1
|
—
|
14.3 Percentage of Participants
Interval 6.4 to 26.2
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
18-64 years
|
8.9 Percentage of Participants
Interval 3.0 to 19.6
|
17.6 Percentage of Participants
Interval 8.4 to 30.9
|
12.5 Percentage of Participants
Interval 5.2 to 24.1
|
36.5 Percentage of Participants
Interval 23.6 to 51.0
|
22.2 Percentage of Participants
Interval 12.0 to 35.6
|
28.6 Percentage of Participants
Interval 16.6 to 43.3
|
10.7 Percentage of Participants
Interval 4.0 to 21.9
|
10.2 Percentage of Participants
Interval 3.4 to 22.2
|
10.0 Percentage of Participants
Interval 3.3 to 21.8
|
7.3 Percentage of Participants
Interval 2.0 to 17.6
|
9.4 Percentage of Participants
Interval 3.1 to 20.7
|
20.8 Percentage of Participants
Interval 10.8 to 34.1
|
—
|
22.4 Percentage of Participants
Interval 11.8 to 36.6
|
—
|
|
The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
≥65 years
|
7.5 Percentage of Participants
Interval 2.1 to 18.2
|
12.3 Percentage of Participants
Interval 5.1 to 23.7
|
—
|
44.1 Percentage of Participants
Interval 31.2 to 57.6
|
23.7 Percentage of Participants
Interval 13.6 to 36.6
|
—
|
—
|
15.1 Percentage of Participants
Interval 6.7 to 27.6
|
10.7 Percentage of Participants
Interval 4.0 to 21.9
|
—
|
16.9 Percentage of Participants
Interval 8.4 to 29.0
|
19.6 Percentage of Participants
Interval 10.2 to 32.4
|
47.3 Percentage of Participants
Interval 33.7 to 61.2
|
—
|
35.6 Percentage of Participants
Interval 23.6 to 49.1
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=103 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
≥65 years
|
3.8 Percentage of Participants
Interval 0.5 to 13.0
|
1.8 Percentage of Participants
Interval 0.0 to 9.7
|
—
|
52.5 Percentage of Participants
Interval 39.1 to 65.7
|
19.6 Percentage of Participants
Interval 10.2 to 32.4
|
—
|
—
|
12.2 Percentage of Participants
Interval 4.6 to 24.8
|
5.6 Percentage of Participants
Interval 1.2 to 15.4
|
—
|
10.2 Percentage of Participants
Interval 3.8 to 20.8
|
9.4 Percentage of Participants
Interval 3.1 to 20.7
|
52.7 Percentage of Participants
Interval 38.8 to 66.3
|
—
|
21.4 Percentage of Participants
Interval 11.6 to 34.4
|
|
The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
18-64 years
|
0.0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
3.8 Percentage of Participants
Interval 0.5 to 13.0
|
57.1 Percentage of Participants
Interval 42.2 to 71.2
|
19.6 Percentage of Participants
Interval 9.8 to 33.1
|
47.9 Percentage of Participants
Interval 33.3 to 62.8
|
3.8 Percentage of Participants
Interval 0.5 to 13.0
|
6.3 Percentage of Participants
Interval 1.3 to 17.2
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
0.0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0.0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
9.6 Percentage of Participants
Interval 3.2 to 21.0
|
—
|
19.1 Percentage of Participants
Interval 9.1 to 33.3
|
—
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
18-64 years
|
37.5 Percentage of Participants
Interval 24.9 to 51.5
|
35.3 Percentage of Participants
Interval 22.4 to 49.9
|
28.6 Percentage of Participants
Interval 17.3 to 42.2
|
3.8 Percentage of Participants
Interval 0.5 to 13.2
|
3.7 Percentage of Participants
Interval 0.5 to 12.7
|
0.0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
41.1 Percentage of Participants
Interval 28.1 to 55.0
|
69.4 Percentage of Participants
Interval 54.6 to 81.7
|
54.0 Percentage of Participants
Interval 39.3 to 68.2
|
54.5 Percentage of Participants
Interval 40.6 to 68.0
|
52.8 Percentage of Participants
Interval 38.6 to 66.7
|
52.8 Percentage of Participants
Interval 38.6 to 66.7
|
—
|
6.1 Percentage of Participants
Interval 1.3 to 16.9
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
≥65 years
|
37.7 Percentage of Participants
Interval 24.8 to 52.1
|
38.6 Percentage of Participants
Interval 26.0 to 52.4
|
—
|
8.5 Percentage of Participants
Interval 2.8 to 18.7
|
0.0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
—
|
58.5 Percentage of Participants
Interval 44.1 to 71.9
|
57.1 Percentage of Participants
Interval 43.2 to 70.3
|
—
|
54.2 Percentage of Participants
Interval 40.8 to 67.3
|
53.6 Percentage of Participants
Interval 39.7 to 67.0
|
10.9 Percentage of Participants
Interval 4.1 to 22.2
|
—
|
8.5 Percentage of Participants
Interval 2.8 to 18.7
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 43.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
18-64 years
|
75.4 Percentage of Participants
Interval 62.2 to 85.9
|
66.7 Percentage of Participants
Interval 52.1 to 79.2
|
57.1 Percentage of Participants
Interval 43.2 to 70.3
|
1.9 Percentage of Participants
Interval 0.0 to 10.3
|
7.3 Percentage of Participants
Interval 2.0 to 17.6
|
8.0 Percentage of Participants
Interval 2.2 to 19.2
|
85.7 Percentage of Participants
Interval 73.8 to 93.6
|
89.8 Percentage of Participants
Interval 77.8 to 96.6
|
96.0 Percentage of Participants
Interval 86.3 to 99.5
|
87.3 Percentage of Participants
Interval 75.5 to 94.7
|
81.1 Percentage of Participants
Interval 68.0 to 90.6
|
79.2 Percentage of Participants
Interval 65.9 to 89.2
|
—
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
≥65 years
|
52.8 Percentage of Participants
Interval 38.6 to 66.7
|
61.4 Percentage of Participants
Interval 47.6 to 74.0
|
—
|
11.9 Percentage of Participants
Interval 4.9 to 22.9
|
5.1 Percentage of Participants
Interval 1.1 to 14.1
|
—
|
—
|
86.8 Percentage of Participants
Interval 74.7 to 94.5
|
80.4 Percentage of Participants
Interval 67.6 to 89.8
|
—
|
78.0 Percentage of Participants
Interval 65.3 to 87.7
|
76.8 Percentage of Participants
Interval 63.6 to 87.0
|
18.2 Percentage of Participants
Interval 9.1 to 30.9
|
—
|
3.4 Percentage of Participants
Interval 0.4 to 11.7
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=103 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
18-64 years
|
43.6 Percentage of Participants
Interval 30.3 to 57.7
|
38.8 Percentage of Participants
Interval 25.2 to 53.8
|
34.0 Percentage of Participants
Interval 21.5 to 48.3
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
2.0 Percentage of Participants
Interval 0.0 to 10.4
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
62.3 Percentage of Participants
Interval 47.9 to 75.2
|
70.8 Percentage of Participants
Interval 55.9 to 83.0
|
77.6 Percentage of Participants
Interval 63.4 to 88.2
|
60.0 Percentage of Participants
Interval 45.2 to 73.6
|
60.0 Percentage of Participants
Interval 45.2 to 73.6
|
53.8 Percentage of Participants
Interval 39.5 to 67.8
|
—
|
2.1 Percentage of Participants
Interval 0.1 to 11.3
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
≥65 years
|
26.4 Percentage of Participants
Interval 15.3 to 40.3
|
36.4 Percentage of Participants
Interval 23.8 to 50.4
|
—
|
8.5 Percentage of Participants
Interval 2.8 to 18.7
|
3.6 Percentage of Participants
Interval 0.4 to 12.3
|
—
|
—
|
61.2 Percentage of Participants
Interval 46.2 to 74.8
|
61.1 Percentage of Participants
Interval 46.9 to 74.1
|
—
|
59.3 Percentage of Participants
Interval 45.7 to 71.9
|
60.4 Percentage of Participants
Interval 46.0 to 73.5
|
5.5 Percentage of Participants
Interval 1.1 to 15.1
|
—
|
12.5 Percentage of Participants
Interval 5.2 to 24.1
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
18-64 years
|
8.9 Percentage of Participants
Interval 3.0 to 19.6
|
17.6 Percentage of Participants
Interval 8.4 to 30.9
|
12.5 Percentage of Participants
Interval 5.2 to 24.1
|
36.5 Percentage of Participants
Interval 23.6 to 51.0
|
22.2 Percentage of Participants
Interval 12.0 to 35.6
|
28.6 Percentage of Participants
Interval 16.6 to 43.3
|
10.7 Percentage of Participants
Interval 4.0 to 21.9
|
6.1 Percentage of Participants
Interval 1.3 to 16.9
|
10.0 Percentage of Participants
Interval 3.3 to 21.8
|
7.3 Percentage of Participants
Interval 2.0 to 17.6
|
9.4 Percentage of Participants
Interval 3.1 to 20.7
|
20.8 Percentage of Participants
Interval 10.8 to 34.1
|
—
|
22.4 Percentage of Participants
Interval 11.8 to 36.6
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
≥65 years
|
5.7 Percentage of Participants
Interval 1.2 to 15.7
|
8.8 Percentage of Participants
Interval 2.9 to 19.3
|
—
|
40.7 Percentage of Participants
Interval 28.1 to 54.3
|
22.0 Percentage of Participants
Interval 12.3 to 34.7
|
—
|
—
|
13.2 Percentage of Participants
Interval 5.5 to 25.3
|
7.1 Percentage of Participants
Interval 2.0 to 17.3
|
—
|
13.6 Percentage of Participants
Interval 6.0 to 25.0
|
16.1 Percentage of Participants
Interval 7.6 to 28.3
|
45.5 Percentage of Participants
Interval 32.0 to 59.4
|
—
|
35.6 Percentage of Participants
Interval 23.6 to 49.1
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 43.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
≥65 years
|
5.7 Percentage of Participants
Interval 1.2 to 15.7
|
7.0 Percentage of Participants
Interval 1.9 to 17.0
|
—
|
79.7 Percentage of Participants
Interval 67.2 to 89.0
|
33.9 Percentage of Participants
Interval 22.1 to 47.4
|
—
|
—
|
9.4 Percentage of Participants
Interval 3.1 to 20.7
|
10.7 Percentage of Participants
Interval 4.0 to 21.9
|
—
|
15.3 Percentage of Participants
Interval 7.2 to 27.0
|
14.3 Percentage of Participants
Interval 6.4 to 26.2
|
70.9 Percentage of Participants
Interval 57.1 to 82.4
|
—
|
44.1 Percentage of Participants
Interval 31.2 to 57.6
|
|
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
18-64 years
|
7.0 Percentage of Participants
Interval 1.9 to 17.0
|
5.9 Percentage of Participants
Interval 1.2 to 16.2
|
8.9 Percentage of Participants
Interval 3.0 to 19.6
|
84.6 Percentage of Participants
Interval 71.9 to 93.1
|
65.5 Percentage of Participants
Interval 51.4 to 77.8
|
84.0 Percentage of Participants
Interval 70.9 to 92.8
|
8.9 Percentage of Participants
Interval 3.0 to 19.6
|
14.3 Percentage of Participants
Interval 5.9 to 27.2
|
8.0 Percentage of Participants
Interval 2.2 to 19.2
|
3.6 Percentage of Participants
Interval 0.4 to 12.5
|
5.7 Percentage of Participants
Interval 1.2 to 15.7
|
22.6 Percentage of Participants
Interval 12.3 to 36.2
|
—
|
59.2 Percentage of Participants
Interval 44.2 to 73.0
|
—
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=103 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
≥65 years
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
1.8 Percentage of Participants
Interval 0.0 to 9.7
|
—
|
45.8 Percentage of Participants
Interval 32.7 to 59.2
|
16.1 Percentage of Participants
Interval 7.6 to 28.3
|
—
|
—
|
10.2 Percentage of Participants
Interval 3.4 to 22.2
|
3.7 Percentage of Participants
Interval 0.5 to 12.7
|
—
|
8.5 Percentage of Participants
Interval 2.8 to 18.7
|
7.5 Percentage of Participants
Interval 2.1 to 18.2
|
47.3 Percentage of Participants
Interval 33.7 to 61.2
|
—
|
17.9 Percentage of Participants
Interval 8.9 to 30.4
|
|
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
18-64 years
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
3.8 Percentage of Participants
Interval 0.5 to 13.0
|
55.1 Percentage of Participants
Interval 40.2 to 69.3
|
19.6 Percentage of Participants
Interval 9.8 to 33.1
|
47.9 Percentage of Participants
Interval 33.3 to 62.8
|
3.8 Percentage of Participants
Interval 0.5 to 13.0
|
2.1 Percentage of Participants
Interval 0.1 to 11.1
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
7.7 Percentage of Participants
Interval 2.1 to 18.5
|
—
|
19.1 Percentage of Participants
Interval 9.1 to 33.3
|
—
|
SECONDARY outcome
Timeframe: Screening (i.e., pre-vaccination)Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Screening.
Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Screening.
18-64 years
|
5.06 Titers
Interval 4.94 to 5.19
|
5.07 Titers
Interval 4.93 to 5.21
|
5.13 Titers
Interval 4.88 to 5.39
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.35 Titers
Interval 4.67 to 6.13
|
5.22 Titers
Interval 4.97 to 5.47
|
5.25 Titers
Interval 4.87 to 5.65
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.34 Titers
Interval 4.68 to 6.09
|
5.55 Titers
Interval 4.5 to 6.85
|
—
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
—
|
|
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Screening.
≥65 years
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.28 Titers
Interval 4.84 to 5.77
|
—
|
5.37 Titers
Interval 4.83 to 5.96
|
5.40 Titers
Interval 4.93 to 5.91
|
—
|
—
|
5.41 Titers
Interval 4.81 to 6.08
|
5.49 Titers
Interval 4.89 to 6.16
|
—
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.13 Titers
Interval 4.95 to 5.31
|
5.19 Titers
Interval 4.81 to 5.6
|
—
|
5.86 Titers
Interval 4.86 to 7.06
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=54 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=100 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 22.
18-64 years
|
21.28 Titers
Interval 14.25 to 31.77
|
14.24 Titers
Interval 9.61 to 21.09
|
15.23 Titers
Interval 10.23 to 22.69
|
5.49 Titers
Interval 4.55 to 6.62
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
5.14 Titers
Interval 4.94 to 5.35
|
34.96 Titers
Interval 22.4 to 54.55
|
41.77 Titers
Interval 28.26 to 61.75
|
38.10 Titers
Interval 24.59 to 59.03
|
27.58 Titers
Interval 19.09 to 39.84
|
23.70 Titers
Interval 16.19 to 34.69
|
21.40 Titers
Interval 14.37 to 31.89
|
—
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
—
|
|
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 22.
≥65 years
|
10.20 Titers
Interval 7.3 to 14.25
|
12.89 Titers
Interval 8.88 to 18.71
|
—
|
5.62 Titers
Interval 4.77 to 6.63
|
5.40 Titers
Interval 4.63 to 6.29
|
—
|
—
|
17.74 Titers
Interval 13.22 to 23.8
|
29.71 Titers
Interval 19.53 to 45.19
|
—
|
18.42 Titers
Interval 12.68 to 26.75
|
22.12 Titers
Interval 14.52 to 33.69
|
6.81 Titers
Interval 5.24 to 8.85
|
—
|
5.93 Titers
Interval 4.88 to 7.21
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 43.
Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=54 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 43.
≥65 years
|
51.86 Titers
Interval 33.39 to 80.55
|
60.84 Titers
Interval 40.71 to 90.94
|
—
|
6.55 Titers
Interval 5.13 to 8.37
|
5.46 Titers
Interval 4.72 to 6.31
|
—
|
—
|
211.92 Titers
Interval 147.29 to 304.93
|
148.53 Titers
Interval 99.21 to 222.37
|
—
|
179.95 Titers
Interval 125.02 to 259.01
|
162.00 Titers
Interval 118.1 to 222.22
|
8.12 Titers
Interval 5.75 to 11.47
|
—
|
6.07 Titers
Interval 4.84 to 7.61
|
|
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 43.
18-64 years
|
129.33 Titers
Interval 92.34 to 181.14
|
111.57 Titers
Interval 74.17 to 167.83
|
84.04 Titers
Interval 54.11 to 130.52
|
5.53 Titers
Interval 4.64 to 6.59
|
5.46 Titers
Interval 4.69 to 6.37
|
6.07 Titers
Interval 4.83 to 7.63
|
433.35 Titers
Interval 330.18 to 568.78
|
492.63 Titers
Interval 362.09 to 670.22
|
331.29 Titers
Interval 250.7 to 437.79
|
269.09 Titers
Interval 198.33 to 365.1
|
203.79 Titers
Interval 136.32 to 304.65
|
198.53 Titers
Interval 144.05 to 273.62
|
—
|
5.29 Titers
Interval 4.72 to 5.93
|
—
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 203.
18-64 years
|
21.18 Titers
Interval 16.15 to 27.78
|
16.06 Titers
Interval 11.67 to 22.09
|
16.76 Titers
Interval 12.13 to 23.15
|
5.33 Titers
Interval 4.81 to 5.91
|
5.21 Titers
Interval 4.8 to 5.65
|
5.07 Titers
Interval 4.93 to 5.22
|
34.19 Titers
Interval 25.08 to 46.6
|
41.47 Titers
Interval 28.75 to 59.81
|
46.74 Titers
Interval 33.23 to 65.75
|
27.13 Titers
Interval 19.6 to 37.55
|
29.08 Titers
Interval 19.77 to 42.77
|
30.23 Titers
Interval 21.86 to 41.81
|
—
|
5.00 Titers
The lower and upper confidence limits are not estimable due to the standard deviation of zero.
|
—
|
|
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 203.
≥65 years
|
11.85 Titers
Interval 8.6 to 16.34
|
13.79 Titers
Interval 10.51 to 18.09
|
—
|
5.76 Titers
Interval 4.94 to 6.71
|
5.59 Titers
Interval 4.69 to 6.67
|
—
|
—
|
25.61 Titers
Interval 19.42 to 33.76
|
31.81 Titers
Interval 22.84 to 44.32
|
—
|
29.47 Titers
Interval 21.58 to 40.24
|
27.37 Titers
Interval 19.16 to 39.1
|
5.78 Titers
Interval 4.98 to 6.7
|
—
|
5.76 Titers
Interval 4.96 to 6.7
|
SECONDARY outcome
Timeframe: Screening (i.e., pre-vaccination)Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Screening.
Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.
18-64 years
|
5.06 Titers
Interval 4.94 to 5.19
|
5.39 Titers
Interval 4.92 to 5.9
|
5.52 Titers
Interval 4.95 to 6.15
|
5.54 Titers
Interval 5.09 to 6.02
|
5.64 Titers
Interval 5.04 to 6.3
|
5.36 Titers
Interval 4.92 to 5.83
|
5.49 Titers
Interval 5.01 to 6.01
|
6.14 Titers
Interval 5.05 to 7.46
|
5.78 Titers
Interval 5.08 to 6.58
|
5.29 Titers
Interval 4.95 to 5.66
|
5.17 Titers
Interval 4.93 to 5.41
|
5.74 Titers
Interval 4.95 to 6.64
|
—
|
5.22 Titers
Interval 4.97 to 5.47
|
—
|
|
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.
≥65 years
|
5.89 Titers
Interval 5.08 to 6.82
|
6.21 Titers
Interval 5.35 to 7.21
|
—
|
7.29 Titers
Interval 5.77 to 9.19
|
6.21 Titers
Interval 4.99 to 7.74
|
—
|
—
|
6.49 Titers
Interval 5.37 to 7.85
|
7.25 Titers
Interval 5.7 to 9.21
|
—
|
6.14 Titers
Interval 5.33 to 7.08
|
6.65 Titers
Interval 5.58 to 7.91
|
7.92 Titers
Interval 6.13 to 10.23
|
—
|
6.71 Titers
Interval 5.33 to 8.44
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=101 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=58 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.
18-64 years
|
7.44 Titers
Interval 5.98 to 9.24
|
7.37 Titers
Interval 5.4 to 10.05
|
8.49 Titers
Interval 5.85 to 12.31
|
30.03 Titers
Interval 18.79 to 47.98
|
14.23 Titers
Interval 9.84 to 20.58
|
19.44 Titers
Interval 12.43 to 30.39
|
7.72 Titers
Interval 5.89 to 10.14
|
8.23 Titers
Interval 6.2 to 10.91
|
9.52 Titers
Interval 6.96 to 13.04
|
7.30 Titers
Interval 5.78 to 9.21
|
7.80 Titers
Interval 6.45 to 9.43
|
11.22 Titers
Interval 7.44 to 16.93
|
—
|
11.52 Titers
Interval 8.5 to 15.61
|
—
|
|
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.
≥65 years
|
7.45 Titers
Interval 5.78 to 9.6
|
10.37 Titers
Interval 7.43 to 14.48
|
—
|
36.41 Titers
Interval 22.17 to 59.77
|
13.18 Titers
Interval 8.88 to 19.56
|
—
|
—
|
8.49 Titers
Interval 6.67 to 10.81
|
10.25 Titers
Interval 7.74 to 13.57
|
—
|
11.86 Titers
Interval 8.47 to 16.6
|
12.73 Titers
Interval 9.09 to 17.83
|
41.54 Titers
Interval 24.63 to 70.07
|
—
|
19.53 Titers
Interval 12.76 to 29.89
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 43.
Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=54 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=54 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.
18-64 years
|
8.96 Titers
Interval 7.27 to 11.04
|
8.55 Titers
Interval 6.23 to 11.74
|
12.04 Titers
Interval 8.28 to 17.51
|
311.57 Titers
Interval 217.39 to 446.55
|
106.22 Titers
Interval 72.43 to 155.8
|
294.45 Titers
Interval 196.45 to 441.33
|
16.70 Titers
Interval 11.95 to 23.35
|
18.89 Titers
Interval 13.53 to 26.39
|
13.95 Titers
Interval 10.16 to 19.15
|
10.26 Titers
Interval 8.05 to 13.06
|
11.78 Titers
Interval 8.43 to 16.44
|
17.43 Titers
Interval 11.4 to 26.65
|
—
|
77.21 Titers
Interval 49.66 to 120.02
|
—
|
|
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.
≥65 years
|
10.67 Titers
Interval 7.89 to 14.44
|
12.00 Titers
Interval 8.54 to 16.87
|
—
|
251.51 Titers
Interval 168.45 to 375.53
|
44.54 Titers
Interval 30.59 to 64.84
|
—
|
—
|
14.80 Titers
Interval 10.78 to 20.32
|
16.41 Titers
Interval 11.99 to 22.45
|
—
|
18.72 Titers
Interval 12.86 to 27.25
|
24.99 Titers
Interval 16.51 to 37.83
|
219.26 Titers
Interval 143.42 to 335.21
|
—
|
57.24 Titers
Interval 37.21 to 88.04
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=52 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=103 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203.
18-64 years
|
7.58 Titers
Interval 6.34 to 9.06
|
7.97 Titers
Interval 6.22 to 10.21
|
9.23 Titers
Interval 6.84 to 12.46
|
78.88 Titers
Interval 54.54 to 114.1
|
30.89 Titers
Interval 22.65 to 42.12
|
61.24 Titers
Interval 44.33 to 84.61
|
10.40 Titers
Interval 8.05 to 13.42
|
14.24 Titers
Interval 10.33 to 19.62
|
12.19 Titers
Interval 9.2 to 16.15
|
7.74 Titers
Interval 6.54 to 9.16
|
8.95 Titers
Interval 7.46 to 10.73
|
12.21 Titers
Interval 8.92 to 16.71
|
—
|
27.25 Titers
Interval 19.72 to 37.66
|
—
|
|
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203.
≥65 years
|
8.60 Titers
Interval 6.8 to 10.88
|
9.81 Titers
Interval 7.69 to 12.52
|
—
|
70.30 Titers
Interval 49.17 to 100.49
|
25.14 Titers
Interval 18.45 to 34.25
|
—
|
—
|
12.36 Titers
Interval 9.46 to 16.14
|
12.76 Titers
Interval 9.44 to 17.24
|
—
|
11.31 Titers
Interval 8.69 to 14.73
|
15.60 Titers
Interval 11.05 to 22.03
|
85.20 Titers
Interval 60.31 to 120.36
|
—
|
25.45 Titers
Interval 18.74 to 34.57
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=54 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=100 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
18-64 years
|
30.4 Percentage of Participants
Interval 18.8 to 44.1
|
17.6 Percentage of Participants
Interval 8.4 to 30.9
|
23.2 Percentage of Participants
Interval 13.0 to 36.4
|
1.9 Percentage of Participants
Interval 0.0 to 10.3
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
50.0 Percentage of Participants
Interval 36.1 to 63.9
|
56.3 Percentage of Participants
Interval 41.2 to 70.5
|
46.0 Percentage of Participants
Interval 31.8 to 60.7
|
45.5 Percentage of Participants
Interval 32.0 to 59.4
|
35.8 Percentage of Participants
Interval 23.1 to 50.2
|
27.5 Percentage of Participants
Interval 15.9 to 41.7
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
≥65 years
|
9.4 Percentage of Participants
Interval 3.1 to 20.7
|
19.6 Percentage of Participants
Interval 10.2 to 32.4
|
—
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
—
|
—
|
21.2 Percentage of Participants
Interval 11.1 to 34.7
|
42.9 Percentage of Participants
Interval 29.7 to 56.8
|
—
|
27.1 Percentage of Participants
Interval 16.4 to 40.3
|
34.5 Percentage of Participants
Interval 22.2 to 48.6
|
7.3 Percentage of Participants
Interval 2.0 to 17.6
|
—
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 43.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=114 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=54 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
18-64 years
|
84.2 Percentage of Participants
Interval 72.1 to 92.5
|
82.0 Percentage of Participants
Interval 68.6 to 91.4
|
62.5 Percentage of Participants
Interval 48.5 to 75.1
|
1.9 Percentage of Participants
Interval 0.0 to 10.3
|
1.8 Percentage of Participants
Interval 0.0 to 9.7
|
6.0 Percentage of Participants
Interval 1.3 to 16.5
|
96.4 Percentage of Participants
Interval 87.7 to 99.6
|
95.9 Percentage of Participants
Interval 86.0 to 99.5
|
96.0 Percentage of Participants
Interval 86.3 to 99.5
|
94.4 Percentage of Participants
Interval 84.6 to 98.8
|
83.0 Percentage of Participants
Interval 70.2 to 91.9
|
92.5 Percentage of Participants
Interval 81.8 to 97.9
|
—
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
≥65 years
|
57.7 Percentage of Participants
Interval 43.2 to 71.3
|
61.4 Percentage of Participants
Interval 47.6 to 74.0
|
—
|
3.4 Percentage of Participants
Interval 0.4 to 11.7
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
—
|
—
|
88.7 Percentage of Participants
Interval 77.0 to 95.7
|
80.4 Percentage of Participants
Interval 67.6 to 89.8
|
—
|
86.4 Percentage of Participants
Interval 75.0 to 94.0
|
91.1 Percentage of Participants
Interval 80.4 to 97.0
|
10.9 Percentage of Participants
Interval 4.1 to 22.2
|
—
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
18-64 years
|
33.3 Percentage of Participants
Interval 21.1 to 47.5
|
18.4 Percentage of Participants
Interval 8.8 to 32.0
|
28.3 Percentage of Participants
Interval 16.8 to 42.3
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
2.0 Percentage of Participants
Interval 0.0 to 10.4
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
52.8 Percentage of Participants
Interval 38.6 to 66.7
|
54.2 Percentage of Participants
Interval 39.2 to 68.6
|
59.2 Percentage of Participants
Interval 44.2 to 73.0
|
38.0 Percentage of Participants
Interval 24.7 to 52.8
|
46.0 Percentage of Participants
Interval 31.8 to 60.7
|
42.3 Percentage of Participants
Interval 28.7 to 56.8
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
≥65 years
|
18.9 Percentage of Participants
Interval 9.4 to 32.0
|
20.0 Percentage of Participants
Interval 10.4 to 33.0
|
—
|
1.7 Percentage of Participants
Interval 0.0 to 9.1
|
1.8 Percentage of Participants
Interval 0.0 to 9.6
|
—
|
—
|
42.9 Percentage of Participants
Interval 28.8 to 57.8
|
49.1 Percentage of Participants
Interval 35.1 to 63.2
|
—
|
42.4 Percentage of Participants
Interval 29.6 to 55.9
|
43.4 Percentage of Participants
Interval 29.8 to 57.7
|
1.8 Percentage of Participants
Interval 0.0 to 9.7
|
—
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
SECONDARY outcome
Timeframe: Day 22Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 22.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=101 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=112 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=58 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
18-64 years
|
3.6 Percentage of Participants
Interval 0.4 to 12.5
|
5.9 Percentage of Participants
Interval 1.2 to 16.2
|
9.1 Percentage of Participants
Interval 3.0 to 20.0
|
36.5 Percentage of Participants
Interval 23.6 to 51.0
|
18.9 Percentage of Participants
Interval 9.4 to 32.0
|
30.6 Percentage of Participants
Interval 18.3 to 45.4
|
7.3 Percentage of Participants
Interval 2.0 to 17.6
|
6.3 Percentage of Participants
Interval 1.3 to 17.2
|
6.0 Percentage of Participants
Interval 1.3 to 16.5
|
5.5 Percentage of Participants
Interval 1.1 to 15.1
|
3.8 Percentage of Participants
Interval 0.5 to 13.0
|
13.7 Percentage of Participants
Interval 5.7 to 26.3
|
—
|
12.2 Percentage of Participants
Interval 4.6 to 24.8
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
≥65 years
|
1.9 Percentage of Participants
Interval 0.0 to 10.1
|
7.0 Percentage of Participants
Interval 1.9 to 17.0
|
—
|
39.0 Percentage of Participants
Interval 26.5 to 52.6
|
13.6 Percentage of Participants
Interval 6.0 to 25.0
|
—
|
—
|
5.7 Percentage of Participants
Interval 1.3 to 15.7
|
7.1 Percentage of Participants
Interval 2.0 to 17.3
|
—
|
15.3 Percentage of Participants
Interval 7.2 to 27.0
|
16.1 Percentage of Participants
Interval 7.6 to 28.3
|
47.3 Percentage of Participants
Interval 33.7 to 61.2
|
—
|
27.6 Percentage of Participants
Interval 16.7 to 40.9
|
SECONDARY outcome
Timeframe: Day 43Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 43.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=110 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=113 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=54 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=102 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=106 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=54 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=111 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=49 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=59 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
18-64 years
|
8.8 Percentage of Participants
Interval 2.9 to 19.3
|
3.9 Percentage of Participants
Interval 0.5 to 13.5
|
16.1 Percentage of Participants
Interval 7.6 to 28.3
|
94.2 Percentage of Participants
Interval 84.1 to 98.8
|
74.5 Percentage of Participants
Interval 61.0 to 85.3
|
94.0 Percentage of Participants
Interval 83.5 to 98.7
|
25.9 Percentage of Participants
Interval 15.0 to 39.7
|
14.3 Percentage of Participants
Interval 5.9 to 27.2
|
18.0 Percentage of Participants
Interval 8.6 to 31.4
|
9.3 Percentage of Participants
Interval 3.1 to 20.3
|
18.9 Percentage of Participants
Interval 9.4 to 32.0
|
20.8 Percentage of Participants
Interval 10.8 to 34.1
|
—
|
71.4 Percentage of Participants
Interval 56.7 to 83.4
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
≥65 years
|
7.5 Percentage of Participants
Interval 2.1 to 18.2
|
14.0 Percentage of Participants
Interval 6.3 to 25.8
|
—
|
89.8 Percentage of Participants
Interval 79.2 to 96.2
|
53.4 Percentage of Participants
Interval 39.9 to 66.7
|
—
|
—
|
22.6 Percentage of Participants
Interval 12.3 to 36.2
|
12.5 Percentage of Participants
Interval 5.2 to 24.1
|
—
|
24.1 Percentage of Participants
Interval 13.9 to 37.2
|
25.0 Percentage of Participants
Interval 14.4 to 38.4
|
89.1 Percentage of Participants
Interval 77.8 to 95.9
|
—
|
61.0 Percentage of Participants
Interval 47.4 to 73.5
|
SECONDARY outcome
Timeframe: Day 203Population: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate results at Day 43 visit within -7/+14 days of the expected date, had no major protocol deviations impacting analyses, and had data at Day 203.
The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
7.5 µg H5N8 Plus MF59
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=104 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N8 Plus MF59
n=52 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=108 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus MF59
n=107 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=48 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Full Dose
n=53 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=97 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=103 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=50 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=109 Participants
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Half Dose
n=105 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=55 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=47 Participants
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=56 Participants
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
18-64 years
|
5.5 Percentage of Participants
Interval 1.1 to 15.1
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
9.6 Percentage of Participants
Interval 3.2 to 21.0
|
77.6 Percentage of Participants
Interval 63.4 to 88.2
|
43.1 Percentage of Participants
Interval 29.3 to 57.8
|
66.7 Percentage of Participants
Interval 51.6 to 79.6
|
11.3 Percentage of Participants
Interval 4.3 to 23.0
|
12.5 Percentage of Participants
Interval 4.7 to 25.2
|
10.2 Percentage of Participants
Interval 3.4 to 22.2
|
0 Percentage of Participants
The confidence interval is not estimable due to the absence of any events within this age group.
|
2.0 Percentage of Participants
Interval 0.1 to 10.6
|
11.5 Percentage of Participants
Interval 4.4 to 23.4
|
—
|
48.9 Percentage of Participants
Interval 34.1 to 63.9
|
—
|
|
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
≥65 years
|
3.8 Percentage of Participants
Interval 0.5 to 13.0
|
5.5 Percentage of Participants
Interval 1.1 to 15.1
|
—
|
64.4 Percentage of Participants
Interval 50.9 to 76.4
|
32.1 Percentage of Participants
Interval 20.3 to 46.0
|
—
|
—
|
6.1 Percentage of Participants
Interval 1.3 to 16.9
|
9.3 Percentage of Participants
Interval 3.1 to 20.3
|
—
|
10.2 Percentage of Participants
Interval 3.8 to 20.8
|
17.0 Percentage of Participants
Interval 8.1 to 29.8
|
76.4 Percentage of Participants
Interval 63.0 to 86.8
|
—
|
32.1 Percentage of Participants
Interval 20.3 to 46.0
|
Adverse Events
3.75 µg H5N8 Plus AS03A Full Dose
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
7.5 µg H5N8 Plus AS03A Full Dose
Serious events: 1 serious events
Other events: 77 other events
Deaths: 0 deaths
15 µg H5N8 Plus AS03A Full Dose
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
3.75 µg H5N8 Plus AS03A Half Dose
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
7.5 µg H5N8 Plus AS03A Half Dose
Serious events: 2 serious events
Other events: 73 other events
Deaths: 0 deaths
15 µg H5N8 Plus AS03A Half Dose
Serious events: 1 serious events
Other events: 75 other events
Deaths: 0 deaths
3.75 µg H5N8 Plus MF59
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
7.5 µg H5N8 Plus MF59
Serious events: 7 serious events
Other events: 52 other events
Deaths: 0 deaths
15 µg H5N8 Plus MF59
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
3.75 µg H5N1 Plus AS03A Full Dose
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
7.5 µg H5N1 Plus AS03A Full Dose
Serious events: 1 serious events
Other events: 79 other events
Deaths: 0 deaths
15 µg H5N1 Plus AS03A Full Dose
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
3.75 µg H5N1 Plus MF59
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
7.5 µg H5N1 Plus MF59
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
15 µg H5N1 Plus MF59
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3.75 µg H5N8 Plus AS03A Full Dose
n=61 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.'
|
15 µg H5N8 Plus AS03A Half Dose
n=120 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
3.75 µg H5N8 Plus MF59
n=60 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N8 Plus MF59
n=120 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus MF59
n=121 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/121 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.84%
1/119 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.85%
1/118 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.84%
1/119 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/121 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/120 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Infections and infestations
Wound infection
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
1/60 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/120 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/120 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/121 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/120 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/120 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/120 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
1/59 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/121 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.84%
1/119 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/120 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/120 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
Other adverse events
| Measure |
3.75 µg H5N8 Plus AS03A Full Dose
n=61 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Full Dose
n=121 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N8 Plus AS03A Full Dose
n=121 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N8 Plus AS03A Half Dose
n=60 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
7.5 µg H5N8 Plus AS03A Half Dose
n=119 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.'
|
15 µg H5N8 Plus AS03A Half Dose
n=120 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a half dose (0.125 mL) of AS03A.
|
3.75 µg H5N8 Plus MF59
n=60 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
7.5 µg H5N8 Plus MF59
n=120 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
15 µg H5N8 Plus MF59
n=119 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with MF59.
|
3.75 µg H5N1 Plus AS03A Full Dose
n=60 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
7.5 µg H5N1 Plus AS03A Full Dose
n=118 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
15 µg H5N1 Plus AS03A Full Dose
n=59 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with a full dose (0.25 mL) of AS03A.
|
3.75 µg H5N1 Plus MF59
n=60 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
7.5 µg H5N1 Plus MF59
n=121 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
15 µg H5N1 Plus MF59
n=61 participants at risk
Participants dosed intramuscularly on Days 1 and 22 with 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) antigen adjuvanted with MF59.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
6/61 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
10.7%
13/121 • Number of events 16 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.6%
8/121 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
4/60 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
6/119 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
7.5%
9/120 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
3/60 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
10.0%
12/120 • Number of events 12 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.4%
4/119 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.3%
5/60 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
7.6%
9/118 • Number of events 9 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.7%
7/60 • Number of events 9 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
7.4%
9/121 • Number of events 11 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
4.9%
3/61 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Gastrointestinal disorders
Nausea
|
14.8%
9/61 • Number of events 11 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.3%
10/121 • Number of events 11 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.3%
10/121 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
3/60 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
4.2%
5/119 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
8/120 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
3/60 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
4/120 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/119 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.3%
5/60 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.1%
6/118 • Number of events 7 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.4%
2/59 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
4/60 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
4.1%
5/121 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
General disorders
Chills
|
16.4%
10/61 • Number of events 12 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
16.5%
20/121 • Number of events 25 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
12.4%
15/121 • Number of events 18 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
2/60 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.4%
10/119 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
7.5%
9/120 • Number of events 9 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
1/60 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
8/120 • Number of events 8 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/119 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.3%
5/60 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
7.6%
9/118 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.1%
3/59 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
2/60 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
4/121 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
4.9%
3/61 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
General disorders
Fatigue
|
29.5%
18/61 • Number of events 26 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
26.4%
32/121 • Number of events 43 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
21.5%
26/121 • Number of events 35 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
26.7%
16/60 • Number of events 24 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
23.5%
28/119 • Number of events 39 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
20.0%
24/120 • Number of events 33 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
25.0%
15/60 • Number of events 19 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
18.3%
22/120 • Number of events 25 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
10.1%
12/119 • Number of events 12 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
28.3%
17/60 • Number of events 25 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
28.0%
33/118 • Number of events 53 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
16.9%
10/59 • Number of events 11 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
16.7%
10/60 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
17.4%
21/121 • Number of events 29 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.2%
5/61 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
General disorders
Injection site erythema
|
14.8%
9/61 • Number of events 11 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
9.1%
11/121 • Number of events 14 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
13.2%
16/121 • Number of events 18 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.3%
5/60 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.8%
14/119 • Number of events 17 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
10.0%
12/120 • Number of events 14 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
4/60 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
4/120 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
2.5%
3/119 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
13.3%
8/60 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
13.6%
16/118 • Number of events 23 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
13.6%
8/59 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
4/60 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
4.1%
5/121 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.6%
4/61 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
General disorders
Injection site induration
|
21.3%
13/61 • Number of events 16 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
15.7%
19/121 • Number of events 22 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.6%
14/121 • Number of events 20 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
4/60 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
12.6%
15/119 • Number of events 18 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
9.2%
11/120 • Number of events 13 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.7%
7/60 • Number of events 8 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
4/120 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
4.2%
5/119 • Number of events 7 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
16.7%
10/60 • Number of events 15 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
17.8%
21/118 • Number of events 31 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
15.3%
9/59 • Number of events 11 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
4/60 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.8%
7/121 • Number of events 7 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
4.9%
3/61 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
General disorders
Injection site pain
|
60.7%
37/61 • Number of events 61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
47.1%
57/121 • Number of events 85 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
43.8%
53/121 • Number of events 83 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
38.3%
23/60 • Number of events 36 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
47.9%
57/119 • Number of events 88 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
43.3%
52/120 • Number of events 77 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
46.7%
28/60 • Number of events 36 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
27.5%
33/120 • Number of events 44 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
23.5%
28/119 • Number of events 41 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
60.0%
36/60 • Number of events 59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
55.1%
65/118 • Number of events 106 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
42.4%
25/59 • Number of events 34 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
30.0%
18/60 • Number of events 26 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
23.1%
28/121 • Number of events 40 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
31.1%
19/61 • Number of events 26 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
General disorders
Pyrexia
|
8.2%
5/61 • Number of events 7 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
4/121 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
2.5%
3/121 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/119 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
4/120 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
2/60 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
1/60 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
2.5%
3/118 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.4%
2/59 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
2/60 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/121 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
2/61 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/121 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.84%
1/119 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
2/60 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.85%
1/118 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
3/60 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/121 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.0%
14/61 • Number of events 15 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.6%
14/121 • Number of events 17 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
9.9%
12/121 • Number of events 12 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
4/60 • Number of events 7 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.8%
14/119 • Number of events 16 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
6/120 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.7%
7/60 • Number of events 7 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
7.5%
9/120 • Number of events 11 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.84%
1/119 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
4/60 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
10.2%
12/118 • Number of events 17 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.1%
3/59 • Number of events 6 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.3%
5/60 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
6/121 • Number of events 8 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
3.3%
2/61 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.8%
20/61 • Number of events 24 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
31.4%
38/121 • Number of events 47 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
27.3%
33/121 • Number of events 39 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
15.0%
9/60 • Number of events 13 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
19.3%
23/119 • Number of events 33 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
25.0%
30/120 • Number of events 40 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
25.0%
15/60 • Number of events 18 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
10.8%
13/120 • Number of events 15 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.7%
8/119 • Number of events 8 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
28.3%
17/60 • Number of events 21 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
25.4%
30/118 • Number of events 40 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
13.6%
8/59 • Number of events 11 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.7%
7/60 • Number of events 7 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
10.7%
13/121 • Number of events 15 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
6.6%
4/61 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Nervous system disorders
Headache
|
23.0%
14/61 • Number of events 21 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
26.4%
32/121 • Number of events 45 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
17.4%
21/121 • Number of events 32 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
23.3%
14/60 • Number of events 21 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
18.5%
22/119 • Number of events 32 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
22.5%
27/120 • Number of events 34 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
28.3%
17/60 • Number of events 27 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
15.8%
19/120 • Number of events 21 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
7.6%
9/119 • Number of events 10 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
21.7%
13/60 • Number of events 15 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
18.6%
22/118 • Number of events 31 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
11.9%
7/59 • Number of events 9 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
20.0%
12/60 • Number of events 14 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
12.4%
15/121 • Number of events 18 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
8.2%
5/61 • Number of events 5 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/61 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/121 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/121 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.84%
1/119 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/120 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
3/60 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/118 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
1/60 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/121 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.6%
1/61 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/61 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
2.5%
3/121 • Number of events 4 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/121 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
2/119 • Number of events 2 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
5.0%
3/60 • Number of events 3 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/120 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/119 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.7%
1/60 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.85%
1/118 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/59 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.00%
0/60 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
0.83%
1/121 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
1.6%
1/61 • Number of events 1 • From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.
|
Additional Information
Michelle Laskowski, MS Biologist - ASPR/BARDA/RQA/RegOps
BADRA
Phone: 202-815-5216
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place