Trial Outcomes & Findings for 2013/2017 H7N9 Prime-Boost Interval (NCT NCT03589807)
NCT ID: NCT03589807
Last Updated: 2021-08-02
Results Overview
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Day 43
Results posted on
2021-08-02
Participant Flow
Participant milestones
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
33
|
32
|
28
|
30
|
|
Overall Study
COMPLETED
|
27
|
23
|
31
|
28
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
2
|
4
|
2
|
1
|
Reasons for withdrawal
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg per 0.5 ml dose of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013: Monovalent split 2013 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg per 0.5 ml dose of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg per 0.5 ml dose of 2017 A/H7N9 IIV administered intramuscularly on Day 121. PBS diluent may be used to achieve targeted dosages.
A/H7N9: Monovalent split 2017 A/H7N9 Inactivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1).
AS03: Oil-in-water emulsion adjuvant.
Phosphate Buffered Saline (PBS) diluent: Diluent for Influenza Virus Vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Enrolled but treatment not administered
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
One subject in group 5 has missing value for BMI.
Baseline characteristics by cohort
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 8.2 • n=27 Participants
|
29.7 years
STANDARD_DEVIATION 7.5 • n=30 Participants
|
29.6 years
STANDARD_DEVIATION 7.7 • n=33 Participants
|
32.8 years
STANDARD_DEVIATION 9.2 • n=32 Participants
|
31.2 years
STANDARD_DEVIATION 7.7 • n=28 Participants
|
30.6 years
STANDARD_DEVIATION 8.4 • n=30 Participants
|
31.0 years
STANDARD_DEVIATION 8.1 • n=180 Participants
|
|
Age, Customized
19-34
|
16 participants
n=27 Participants
|
24 participants
n=30 Participants
|
25 participants
n=33 Participants
|
19 participants
n=32 Participants
|
19 participants
n=28 Participants
|
19 participants
n=30 Participants
|
122 participants
n=180 Participants
|
|
Age, Customized
35-50
|
11 participants
n=27 Participants
|
6 participants
n=30 Participants
|
8 participants
n=33 Participants
|
13 participants
n=32 Participants
|
9 participants
n=28 Participants
|
11 participants
n=30 Participants
|
58 participants
n=180 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=27 Participants
|
19 Participants
n=30 Participants
|
23 Participants
n=33 Participants
|
19 Participants
n=32 Participants
|
19 Participants
n=28 Participants
|
15 Participants
n=30 Participants
|
106 Participants
n=180 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=27 Participants
|
11 Participants
n=30 Participants
|
10 Participants
n=33 Participants
|
13 Participants
n=32 Participants
|
9 Participants
n=28 Participants
|
15 Participants
n=30 Participants
|
74 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=27 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=33 Participants
|
4 Participants
n=32 Participants
|
3 Participants
n=28 Participants
|
2 Participants
n=30 Participants
|
19 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=27 Participants
|
26 Participants
n=30 Participants
|
29 Participants
n=33 Participants
|
28 Participants
n=32 Participants
|
25 Participants
n=28 Participants
|
28 Participants
n=30 Participants
|
161 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=27 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=27 Participants
|
5 Participants
n=30 Participants
|
11 Participants
n=33 Participants
|
6 Participants
n=32 Participants
|
9 Participants
n=28 Participants
|
4 Participants
n=30 Participants
|
40 Participants
n=180 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=27 Participants
|
22 Participants
n=30 Participants
|
20 Participants
n=33 Participants
|
23 Participants
n=32 Participants
|
17 Participants
n=28 Participants
|
21 Participants
n=30 Participants
|
121 Participants
n=180 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=33 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=28 Participants
|
2 Participants
n=30 Participants
|
11 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=180 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=27 Participants
|
30 participants
n=30 Participants
|
33 participants
n=33 Participants
|
32 participants
n=32 Participants
|
28 participants
n=28 Participants
|
30 participants
n=30 Participants
|
180 participants
n=180 Participants
|
|
Prior Seasonal Influenza Vaccination (Prior Seasons)
2016-2017 Reported
|
15 Participants
n=27 Participants
|
16 Participants
n=30 Participants
|
14 Participants
n=33 Participants
|
20 Participants
n=32 Participants
|
19 Participants
n=28 Participants
|
17 Participants
n=30 Participants
|
101 Participants
n=180 Participants
|
|
Prior Seasonal Influenza Vaccination (Prior Seasons)
2016-2017 Not Reported
|
12 Participants
n=27 Participants
|
14 Participants
n=30 Participants
|
19 Participants
n=33 Participants
|
12 Participants
n=32 Participants
|
9 Participants
n=28 Participants
|
13 Participants
n=30 Participants
|
79 Participants
n=180 Participants
|
|
Prior Seasonal Influenza Vaccination (Prior Seasons)
2017-2018 Reported
|
17 Participants
n=27 Participants
|
18 Participants
n=30 Participants
|
22 Participants
n=33 Participants
|
20 Participants
n=32 Participants
|
20 Participants
n=28 Participants
|
18 Participants
n=30 Participants
|
115 Participants
n=180 Participants
|
|
Prior Seasonal Influenza Vaccination (Prior Seasons)
2017-2018 Not Reported
|
10 Participants
n=27 Participants
|
12 Participants
n=30 Participants
|
11 Participants
n=33 Participants
|
12 Participants
n=32 Participants
|
8 Participants
n=28 Participants
|
12 Participants
n=30 Participants
|
65 Participants
n=180 Participants
|
|
Prior Seasonal Influenza Vaccination (Current Season)
2018-2019 Reported
|
6 Participants
n=27 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=33 Participants
|
7 Participants
n=32 Participants
|
6 Participants
n=28 Participants
|
5 Participants
n=30 Participants
|
33 Participants
n=180 Participants
|
|
Prior Seasonal Influenza Vaccination (Current Season)
2018-2019 Not Reported
|
21 Participants
n=27 Participants
|
27 Participants
n=30 Participants
|
27 Participants
n=33 Participants
|
25 Participants
n=32 Participants
|
22 Participants
n=28 Participants
|
25 Participants
n=30 Participants
|
147 Participants
n=180 Participants
|
|
Prior Receipt of H5 Influenza Vaccine
No Prior H5 Influenza Vaccination(s) Reported
|
24 Participants
n=27 Participants
|
29 Participants
n=30 Participants
|
30 Participants
n=33 Participants
|
31 Participants
n=32 Participants
|
27 Participants
n=28 Participants
|
28 Participants
n=30 Participants
|
169 Participants
n=180 Participants
|
|
Prior Receipt of H5 Influenza Vaccine
Reported Receipt of Prior H5 Influenza Vaccination(s)
|
3 Participants
n=27 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=33 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=30 Participants
|
11 Participants
n=180 Participants
|
|
Body Mass Index (BMI)
|
27.07 kg/m^2
STANDARD_DEVIATION 3.32 • n=27 Participants • One subject in group 5 has missing value for BMI.
|
25.02 kg/m^2
STANDARD_DEVIATION 4.27 • n=30 Participants • One subject in group 5 has missing value for BMI.
|
28.32 kg/m^2
STANDARD_DEVIATION 5.93 • n=33 Participants • One subject in group 5 has missing value for BMI.
|
26.32 kg/m^2
STANDARD_DEVIATION 4.96 • n=32 Participants • One subject in group 5 has missing value for BMI.
|
27.17 kg/m^2
STANDARD_DEVIATION 6.15 • n=27 Participants • One subject in group 5 has missing value for BMI.
|
28.18 kg/m^2
STANDARD_DEVIATION 6.80 • n=30 Participants • One subject in group 5 has missing value for BMI.
|
27.02 kg/m^2
STANDARD_DEVIATION 5.44 • n=179 Participants • One subject in group 5 has missing value for BMI.
|
PRIMARY outcome
Timeframe: Day 43Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Hong Kong/125/2017 (A/H7N9)
|
75.7 titer
Interval 48.0 to 119.4
|
—
|
—
|
65.0 titer
Interval 42.4 to 99.5
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Shanghai/2/2013 (A/H7N9)
|
35.9 titer
Interval 22.5 to 57.5
|
—
|
—
|
19.5 titer
Interval 14.0 to 27.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 142Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 142).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=22 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=31 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Shanghai/2/2013 (A/H7N9)
|
—
|
53.8 titer
Interval 31.7 to 91.4
|
22.6 titer
Interval 14.8 to 34.5
|
—
|
50.6 titer
Interval 30.8 to 83.2
|
17.0 titer
Interval 11.2 to 25.9
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutinin Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
97.2 titer
Interval 55.9 to 169.0
|
43.1 titer
Interval 26.6 to 69.6
|
—
|
133.4 titer
Interval 83.6 to 212.6
|
33.2 titer
Interval 20.3 to 54.5
|
PRIMARY outcome
Timeframe: Day 43Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neutralizing assay which was conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Hong Kong/125/2017 (A/H7N9)
|
55.7 titer
Interval 37.7 to 82.1
|
—
|
—
|
51.2 titer
Interval 37.1 to 70.3
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Shanghai/2/2013 (A/H7N9)
|
86.4 titer
Interval 56.3 to 132.7
|
—
|
—
|
38.7 titer
Interval 27.8 to 53.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 142Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neutralizing assay which was conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=22 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=31 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
286.6 titer
Interval 164.4 to 499.6
|
117.0 titer
Interval 70.7 to 193.6
|
—
|
178.0 titer
Interval 99.9 to 317.1
|
62.7 titer
Interval 38.0 to 103.5
|
|
Geometric Mean Titers (GMTs) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
146.1 titer
Interval 81.4 to 262.4
|
67.3 titer
Interval 42.2 to 107.4
|
—
|
202.0 titer
Interval 113.0 to 361.3
|
64.7 titer
Interval 40.3 to 103.9
|
PRIMARY outcome
Timeframe: Day 1 through Day 387Population: The Safety Analysis population includes all participants who received study vaccination.
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation; or a congenital anomaly/birth defect.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 387 in Participants Who Received Their Second Study Vaccination on Day 22.
|
0 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 486Population: The Safety Analysis population includes all participants who received study vaccination.
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation; or a congenital anomaly/birth defect.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 486 in Participants Who Received Their Second Study Vaccination on Day 121.
|
—
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The Safety Analysis population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 post first vaccination were included for this outcome measure.
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=29 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8
Hemoglobin
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8
Platelets
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8
ALT
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8
Total Bilirubin
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8
Creatinine
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination From Day 1 Through Day 8
WBC
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 121 through Day 128Population: The Safety Analysis population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 post second vaccination were included for this outcome measure.
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=22 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
ALT
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
Total Bilirubin
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
WBC
|
—
|
1 Participants
|
1 Participants
|
—
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
Hemoglobin
|
—
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
Platelets
|
—
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
Creatinine
|
—
|
3 Participants
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 22 through Day 29Population: The Safety Analysis population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 post second vaccination were included for this outcome measure.
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=26 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=29 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Hemoglobin
|
1 Participants
|
—
|
—
|
3 Participants
|
—
|
—
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
WBC
|
4 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Platelets
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
ALT
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Total Bilirubin
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
Creatine
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The Safety Analysis population includes all participants who received study vaccination.
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post First Vaccination From Day 1 Through Day 8
|
25 Participants
|
27 Participants
|
30 Participants
|
28 Participants
|
26 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Day 121 through Day 128Population: The Safety Analysis population includes all participants who received study vaccination.
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=24 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121.
|
—
|
23 Participants
|
12 Participants
|
—
|
24 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 22 through Day 29Population: The Safety Analysis population includes all participants who received study vaccination.
Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=26 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
|
22 Participants
|
—
|
—
|
21 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The Safety Analysis population includes all participants who received study vaccination.
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post First Vaccination From Day 1 Through Day 8
|
17 Participants
|
12 Participants
|
18 Participants
|
10 Participants
|
17 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Day 121 through Day 128Population: The Safety Analysis population includes all participants who received study vaccination.
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=24 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 121 Through Day 128 in Participants Who Received Their Second Study Vaccination on Day 121
|
—
|
7 Participants
|
9 Participants
|
—
|
12 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 22 through Day 29Population: The Safety Analysis population includes all participants who received study vaccination.
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=26 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactogenicity Events Post Second Vaccination From Day 22 Through Day 29 in Participants Who Received Their Second Study Vaccination on Day 22.
|
17 Participants
|
—
|
—
|
10 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 43Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for the HAI assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Shanghai/2/2013 (A/H7N9)
|
52 percentage of participants
Interval 32.0 to 71.0
|
—
|
—
|
35 percentage of participants
Interval 19.0 to 55.0
|
—
|
—
|
|
Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Hong Kong/125/2017 (A/H7N9)
|
81 percentage of participants
Interval 62.0 to 94.0
|
—
|
—
|
81 percentage of participants
Interval 63.0 to 93.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 142Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for the HAI assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142 ).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=22 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=31 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Shanghai/2/2013 (A/H7N9)
|
—
|
77 percentage of participants
Interval 55.0 to 92.0
|
32 percentage of participants
Interval 17.0 to 51.0
|
—
|
69 percentage of participants
Interval 48.0 to 86.0
|
19 percentage of participants
Interval 6.0 to 38.0
|
|
Percentage of Subjects Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
86 percentage of participants
Interval 65.0 to 97.0
|
61 percentage of participants
Interval 42.0 to 78.0
|
—
|
92 percentage of participants
Interval 75.0 to 99.0
|
59 percentage of participants
Interval 39.0 to 78.0
|
PRIMARY outcome
Timeframe: Day 43Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for the Neutralizing assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 43).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
85 percentage of participants
Interval 66.0 to 96.0
|
—
|
—
|
55 percentage of participants
Interval 36.0 to 73.0
|
—
|
—
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
74 percentage of participants
Interval 54.0 to 89.0
|
—
|
—
|
74 percentage of participants
Interval 55.0 to 88.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 142Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for the Neutralizing assay conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post second study vaccination (Day 142).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=22 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=31 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Shanghai/2/2013 (A/H7N9)
|
—
|
95 percentage of participants
Interval 77.0 to 100.0
|
87 percentage of participants
Interval 70.0 to 96.0
|
—
|
92 percentage of participants
Interval 75.0 to 99.0
|
67 percentage of participants
Interval 46.0 to 83.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
91 percentage of participants
Interval 71.0 to 99.0
|
77 percentage of participants
Interval 59.0 to 90.0
|
—
|
92 percentage of participants
Interval 75.0 to 99.0
|
70 percentage of participants
Interval 50.0 to 86.0
|
PRIMARY outcome
Timeframe: Day 43Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 43.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Shanghai/2/2013 (A/H7N9)
|
52 percentage of participants
Interval 32.0 to 71.0
|
—
|
—
|
35 percentage of participants
Interval 19.0 to 55.0
|
—
|
—
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Hong Kong/125/2017 (A/H7N9)
|
78 percentage of participants
Interval 58.0 to 91.0
|
—
|
—
|
81 percentage of participants
Interval 63.0 to 93.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 142Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 142.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=22 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=31 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
86 percentage of participants
Interval 65.0 to 97.0
|
55 percentage of participants
Interval 36.0 to 73.0
|
—
|
85 percentage of participants
Interval 65.0 to 96.0
|
56 percentage of participants
Interval 35.0 to 75.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Shanghai/2/2013 (A/H7N9)
|
—
|
77 percentage of participants
Interval 55.0 to 92.0
|
32 percentage of participants
Interval 17.0 to 51.0
|
—
|
69 percentage of participants
Interval 48.0 to 86.0
|
19 percentage of participants
Interval 6.0 to 38.0
|
PRIMARY outcome
Timeframe: Day 43Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 43.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
Against A/Shanghai/2/2013 (A/H7N9)
|
85 percentage of participants
Interval 66.0 to 96.0
|
—
|
—
|
55 percentage of participants
Interval 36.0 to 73.0
|
—
|
—
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 43 in Participants Who Received Their Second Study Vaccination on Day 22.
A/Hong Kong/125/2017 (A/H7N9)
|
74 percentage of participants
Interval 54.0 to 89.0
|
—
|
—
|
74 percentage of participants
Interval 55.0 to 88.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 142Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second study vaccination is Day 142.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=22 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=31 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=26 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
Against A/Shanghai/2/2013 (A/H7N9)
|
—
|
95 percentage of participants
Interval 77.0 to 100.0
|
84 percentage of participants
Interval 66.0 to 95.0
|
—
|
92 percentage of participants
Interval 75.0 to 99.0
|
63 percentage of participants
Interval 42.0 to 81.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 142 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
91 percentage of participants
Interval 71.0 to 99.0
|
77 percentage of participants
Interval 59.0 to 90.0
|
—
|
92 percentage of participants
Interval 75.0 to 99.0
|
70 percentage of participants
Interval 50.0 to 86.0
|
SECONDARY outcome
Timeframe: Day 1Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
A/Shanghai/2/2013 (A/H7N9)
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
7.3 titer
Interval 7.0 to 7.6
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
A/Hong Kong/125/2017 (A/H7N9)
|
7.4 titer
Interval 4.9 to 11.3
|
5.6 titer
Interval 4.7 to 6.8
|
6.8 titer
Interval 5.1 to 9.1
|
6.5 titer
Interval 5.0 to 8.4
|
6.0 titer
Interval 4.8 to 7.6
|
5.5 titer
Interval 4.5 to 6.9
|
SECONDARY outcome
Timeframe: Day 22Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post first study vaccination (Day 22).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
8.8 titer
Interval 6.8 to 11.4
|
7.9 titer
Interval 6.9 to 9.0
|
7.6 titer
Interval 6.8 to 8.5
|
7.5 titer
Interval 7.0 to 8.1
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
9.7 titer
Interval 6.7 to 14.0
|
8.8 titer
Interval 5.9 to 12.9
|
8.2 titer
Interval 5.9 to 11.4
|
14.6 titer
Interval 8.8 to 24.2
|
8.9 titer
Interval 6.5 to 12.2
|
10.1 titer
Interval 6.5 to 15.5
|
SECONDARY outcome
Timeframe: Day 202Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 202).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
8.1 titer
Interval 6.9 to 9.4
|
—
|
—
|
7.4 titer
Interval 7.0 to 7.8
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
24.7 titer
Interval 15.2 to 40.1
|
—
|
—
|
20.8 titer
Interval 13.5 to 32.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 121Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=32 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=28 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Shanghai/2/2013 (A/H7N9)
|
—
|
7.7 titer
Interval 6.6 to 8.8
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
—
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121.
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
9.3 titer
Interval 6.0 to 14.5
|
8.1 titer
Interval 6.0 to 10.9
|
—
|
9.8 titer
Interval 5.9 to 16.2
|
6.4 titer
Interval 4.8 to 8.5
|
SECONDARY outcome
Timeframe: Day 301Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=20 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
13.3 titer
Interval 9.5 to 18.6
|
8.8 titer
Interval 7.3 to 10.7
|
—
|
11.9 titer
Interval 8.8 to 16.0
|
7.1 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
47.3 titer
Interval 24.7 to 90.7
|
13.8 titer
Interval 8.6 to 22.0
|
—
|
38.8 titer
Interval 22.6 to 66.4
|
8.5 titer
Interval 6.4 to 11.1
|
SECONDARY outcome
Timeframe: Day 1Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
A/Shanghai/2/2013 (A/H7N9)
|
5.3 titer
Interval 4.9 to 5.9
|
5.4 titer
Interval 4.6 to 6.3
|
5.5 titer
Interval 4.6 to 6.5
|
5.1 titer
Interval 4.9 to 5.2
|
5.0 titer
The limits of the 95% confidence interval were not calculable due to having a variance of 0.
|
5.5 titer
Interval 4.6 to 6.7
|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
A/Hong Kong/125/2017 (A/H7N9
|
5.3 titer
Interval 4.9 to 5.8
|
5.5 titer
Interval 4.7 to 6.4
|
5.3 titer
Interval 5.0 to 5.6
|
5.1 titer
Interval 4.9 to 5.4
|
5.2 titer
Interval 5.0 to 5.4
|
5.1 titer
Interval 4.9 to 5.4
|
SECONDARY outcome
Timeframe: Day 22Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days post first study vaccination (Day 22).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
Against A/Shanghai/2/2013 (A/H7N9)
|
11.5 titer
Interval 8.2 to 16.2
|
8.9 titer
Interval 7.2 to 11.0
|
9.6 titer
Interval 7.8 to 11.8
|
6.7 titer
Interval 5.7 to 7.8
|
6.6 titer
Interval 5.7 to 7.8
|
7.7 titer
Interval 6.2 to 9.5
|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
8.1 titer
Interval 6.5 to 10.1
|
7.1 titer
Interval 6.0 to 8.4
|
7.5 titer
Interval 6.5 to 8.6
|
8.3 titer
Interval 6.8 to 10.0
|
8.6 titer
Interval 6.7 to 10.9
|
9.3 titer
Interval 7.4 to 11.7
|
SECONDARY outcome
Timeframe: Day 202Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 202).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
26.9 titer
Interval 20.7 to 34.8
|
—
|
—
|
13.3 titer
Interval 10.5 to 16.9
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
18.5 titer
Interval 14.4 to 23.9
|
—
|
—
|
14.8 titer
Interval 12.1 to 18.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 121Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=32 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=28 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
13.9 titer
Interval 10.4 to 18.8
|
14.5 titer
Interval 11.4 to 18.4
|
—
|
8.5 titer
Interval 6.5 to 11.0
|
8.2 titer
Interval 6.8 to 9.9
|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
11.2 titer
Interval 8.5 to 14.6
|
10.7 titer
Interval 8.7 to 13.1
|
—
|
9.9 titer
Interval 7.8 to 12.5
|
8.7 titer
Interval 7.3 to 10.5
|
SECONDARY outcome
Timeframe: Day 301Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=20 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
52.8 titer
Interval 29.9 to 93.2
|
27.9 titer
Interval 19.9 to 39.1
|
—
|
29.9 titer
Interval 19.2 to 46.6
|
14.9 titer
Interval 10.9 to 20.6
|
|
Geometric Mean Titers (GMT) of Serum Neut Antibodies Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
30.3 titer
Interval 18.7 to 49.0
|
17.8 titer
Interval 13.3 to 23.8
|
—
|
31.2 titer
Interval 20.2 to 48.1
|
15.8 titer
Interval 11.7 to 21.3
|
SECONDARY outcome
Timeframe: Day 1 through Day 387Population: The Safety Analysis population includes all participants who received study vaccination
Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) throughout the duration of the study.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Medically-Attended Adverse Events
|
9 Participants
|
—
|
—
|
8 Participants
|
—
|
—
|
|
Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
New Onset Chronic Medical Conditions
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Received Their Second Study Vaccination on Day 22 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Potentially Immune-Mediated Medical Conditions
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 486Population: The Safety Analysis population includes all participants who received study vaccination.
Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) throughout the duration of the study.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Medically-Attended Adverse Events
|
—
|
12 Participants
|
11 Participants
|
—
|
10 Participants
|
7 Participants
|
|
Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
New Onset Chronic Medical Conditions
|
—
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Received Their Second Study Vaccination on Day 121 Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Potentially Immune Mediated Medical Conditions
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 22Population: The Safety Analysis population includes all participants who received study vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 21 days after the first study vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Non-serious AEs Post First Vaccination From Day 1 Through Day 22
|
9 Participants
|
10 Participants
|
15 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 22 through Day 43Population: The Safety Analysis population includes all participants who received study vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 21 days after the second study vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 22 Through Day 43 in Participants Who Received Their Second Study Vaccination on Day 22
|
7 Participants
|
—
|
—
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 121 through Day 142Population: The Safety Analysis population includes all participants who received study vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 21 days after the second study vaccination.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Non-serious AEs Post Second Vaccination From Day 121 Through Day 142 in Participants Who Received Their Second Study Vaccination on Day 121
|
—
|
5 Participants
|
8 Participants
|
—
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 22Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after first study vaccination is Day 22.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
4 percentage of participants
Interval 0.0 to 19.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 16.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
11 percentage of participants
Interval 2.0 to 19.0
|
11 percentage of participants
Interval 2.0 to 28.0
|
9 percentage of participants
Interval 2.0 to 24.0
|
26 percentage of participants
Interval 12.0 to 45.0
|
11 percentage of participants
Interval 2.0 to 29.0
|
17 percentage of participants
Interval 6.0 to 35.0
|
SECONDARY outcome
Timeframe: Day 202Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after second study vaccination is Day 202.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
4 percentage of participants
Interval 0.0 to 19.0
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 12.0
|
—
|
—
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
41 percentage of participants
Interval 22.0 to 61.0
|
—
|
—
|
33 percentage of participants
Interval 17.0 to 53.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 121Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Immediately prior to second study vaccination is Day 121.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=32 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=28 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
4 percentage of participants
Interval 0.0 to 20.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
—
|
0 percentage of participants
Interval 0.0 to 13.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
16 percentage of participants
Interval 5.0 to 36.0
|
6 percentage of participants
Interval 1.0 to 21.0
|
—
|
11 percentage of participants
Interval 2.0 to 29.0
|
7 percentage of participants
Interval 1.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 301Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after second study vaccination is Day 301.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=20 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
10 percentage of participants
Interval 1.0 to 32.0
|
4 percentage of participants
Interval 0.0 to 19.0
|
—
|
12 percentage of participants
Interval 3.0 to 31.0
|
0 percentage of participants
Interval 0.0 to 14.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Virus on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
75 percentage of participants
Interval 51.0 to 91.0
|
26 percentage of participants
Interval 11.0 to 46.0
|
—
|
56 percentage of participants
Interval 35.0 to 76.0
|
4 percentage of participants
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 22Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after first study vaccination is Day 22.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
11 percentage of participants
Interval 2.0 to 19.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 16.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
3 percentage of participants
Interval 0.0 to 17.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
4 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
3 percentage of participants
Interval 0.0 to 17.0
|
7 percentage of participants
Interval 1.0 to 24.0
|
3 percentage of participants
Interval 0.0 to 17.0
|
SECONDARY outcome
Timeframe: Day 202Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after second study vaccination is Day 202.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
30 percentage of participants
Interval 14.0 to 50.0
|
—
|
—
|
10 percentage of participants
Interval 2.0 to 27.0
|
—
|
—
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
19 percentage of participants
Interval 6.0 to 38.0
|
—
|
—
|
13 percentage of participants
Interval 4.0 to 31.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 121Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Immediately prior to second study vaccination is Day 121.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=32 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=28 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
4 percentage of participants
Interval 0.0 to 20.0
|
3 percentage of participants
Interval 0.0 to 16.0
|
—
|
4 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
12 percentage of participants
Interval 3.0 to 31.0
|
9 percentage of participants
Interval 2.0 to 25.0
|
—
|
4 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Day 301Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer \<1:10 and post-vaccination titer \>= 1:40 or pre-vaccination titer \>= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after second study vaccination is Day 301.
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=20 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
70 percentage of participants
Interval 46.0 to 88.0
|
44 percentage of participants
Interval 25.0 to 65.0
|
—
|
48 percentage of participants
Interval 28.0 to 69.0
|
20 percentage of participants
Interval 7.0 to 41.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
45 percentage of participants
Interval 23.0 to 68.0
|
22 percentage of participants
Interval 9.0 to 42.0
|
—
|
56 percentage of participants
Interval 35.0 to 76.0
|
16 percentage of participants
Interval 5.0 to 36.0
|
SECONDARY outcome
Timeframe: Day 1Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
A/Shanghai/2/2013 (A/H7N9)
|
0 percentage of participants
Interval 0.0 to 13.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 1
A/Hong Kong/125/2017 (A/H7N9)
|
11 percentage of participants
Interval 2.0 to 29.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
6 percentage of participants
Interval 1.0 to 20.0
|
6 percentage of participants
Interval 1.0 to 21.0
|
4 percentage of participants
Interval 0.0 to 19.0
|
3 percentage of participants
Interval 0.0 to 17.0
|
SECONDARY outcome
Timeframe: Day 22Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 21 days post first study vaccination (Day 22).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
4 percentage of participants
Interval 0.0 to 19.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 16.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
15 percentage of participants
Interval 4.0 to 34.0
|
14 percentage of participants
Interval 4.0 to 33.0
|
12 percentage of participants
Interval 3.0 to 28.0
|
29 percentage of participants
Interval 14.0 to 48.0
|
11 percentage of participants
Interval 2.0 to 29.0
|
17 percentage of participants
Interval 6.0 to 35.0
|
SECONDARY outcome
Timeframe: Day 202Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 202).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
4 percentage of participants
Interval 0.0 to 19.0
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 12.0
|
—
|
—
|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
48 percentage of participants
Interval 29.0 to 68.0
|
—
|
—
|
37 percentage of participants
Interval 20.0 to 56.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 121Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=32 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=28 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
4 percentage of participants
Interval 0.0 to 20.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
—
|
0 percentage of participants
Interval 0.0 to 13.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
20 percentage of participants
Interval 7.0 to 41.0
|
6 percentage of participants
Interval 1.0 to 21.0
|
—
|
11 percentage of participants
Interval 2.0 to 29.0
|
7 percentage of participants
Interval 1.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 301Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Blood was collected for HAI assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with HAI titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 301).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=20 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
10 percentage of participants
Interval 1.0 to 32.0
|
4 percentage of participants
Interval 0.0 to 19.0
|
—
|
12 percentage of participants
Interval 3.0 to 31.0
|
0 percentage of participants
Interval 0.0 to 14.0
|
|
Percentage of Participants Achieving HAI Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
75 percentage of participants
Interval 51.0 to 91.0
|
30 percentage of participants
Interval 14.0 to 50.0
|
—
|
64 percentage of participants
Interval 43.0 to 82.0
|
4 percentage of participants
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 1Population: The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neutralizing assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results immediately prior to the first study vaccination (Day 1).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1
A/Shanghai/2/2013 (A/H7N9)
|
0 percentage of participants
Interval 0.0 to 13.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 16.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
3 percentage of participants
Interval 0.0 to 17.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Vaccine Viruses on Day 1
A/Hong Kong/125/2017 (A/H7N9)
|
0 percentage of participants
Interval 0.0 to 13.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Day 22Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 21 days post first study vaccination (Day 22).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=28 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=31 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
11 percentage of participants
Interval 2.0 to 29.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 16.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
3 percentage of participants
Interval 0.0 to 17.0
|
|
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
4 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
3 percentage of participants
Interval 0.0 to 17.0
|
7 percentage of participants
Interval 1.0 to 24.0
|
3 percentage of participants
Interval 0.0 to 17.0
|
SECONDARY outcome
Timeframe: Day 202Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 180 days post first study vaccination (Day 202).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=30 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Shanghai/2/2013 (A/H7N9)
|
33 percentage of participants
Interval 17.0 to 54.0
|
—
|
—
|
10 percentage of participants
Interval 2.0 to 27.0
|
—
|
—
|
|
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 202 in Participants Who Received Their Second Study Vaccination on Day 22
A/Hong Kong/125/2017 (A/H7N9)
|
19 percentage of participants
Interval 6.0 to 38.0
|
—
|
—
|
13 percentage of participants
Interval 4.0 to 31.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 121Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for NEUT assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results immediately prior to second study vaccination (Day 121).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=32 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=28 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
12 percentage of participants
Interval 3.0 to 31.0
|
9 percentage of participants
Interval 2.0 to 25.0
|
—
|
4 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
|
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 121 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
4 percentage of participants
Interval 0.0 to 20.0
|
3 percentage of participants
Interval 0.0 to 16.0
|
—
|
4 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Day 301Population: The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Blood was collected for Neut assay which was conducted with the 2013 and 2017 H7N9 vaccine viruses as the antigens. Each sample was tested at least twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The percentage of participants with Neut titer \>= 1:40 was calculated for each study arm from the available results at 180 days post second study vaccination (Day 301).
Outcome measures
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=20 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=27 Participants
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=25 Participants
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Shanghai/2/2013 (A/H7N9)
|
—
|
70 percentage of participants
Interval 46.0 to 88.0
|
44 percentage of participants
Interval 25.0 to 65.0
|
—
|
48 percentage of participants
Interval 28.0 to 69.0
|
20 percentage of participants
Interval 7.0 to 41.0
|
|
Percentage of Participants Achieving Neut Antibody Titer of 1:40 or Greater Against the Influenza A/H7N9 Study Vaccine Viruses on Day 301 in Participants Who Received Their Second Study Vaccination on Day 121
A/Hong Kong/125/2017 (A/H7N9)
|
—
|
45 percentage of participants
Interval 23.0 to 68.0
|
22 percentage of participants
Interval 9.0 to 42.0
|
—
|
56 percentage of participants
Interval 35.0 to 76.0
|
16 percentage of participants
Interval 5.0 to 36.0
|
Adverse Events
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 participants at risk
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 participants at risk
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 participants at risk
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 participants at risk
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 participants at risk
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 participants at risk
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.0%
1/33 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.2%
2/32 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.1%
1/32 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Social circumstances
Organ donor
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.1%
1/32 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
Other adverse events
| Measure |
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=27 participants at risk
3.75 mcg of 2013 A/H7N9 IIV+ AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 22.
|
2013 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=30 participants at risk
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 121.
|
2013 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=33 participants at risk
3.75 mcg of 2013 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D22)
n=32 participants at risk
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 22.
|
2017 3.75 A/H7N9+AS03| 2017 3.75 A/H7N9 + AS03 (D1-D121)
n=27 participants at risk
3.75 mcg of 2017 A/H7N9 IIV + AS03 adjuvant administered intramuscularly on Day 1 and Day 121.
|
2017 3.75 A/H7N9+AS03| 2017 15 A/H7N9 (D1-D121)
n=30 participants at risk
3.75 mcg of 2017 A/H7N9 IIV + AS03 Adjuvant administered intramuscularly on Day 1 and 15 mcg of 2017 A/H7N9 IIV administered intramuscularly on Day 121.
|
|---|---|---|---|---|---|---|
|
General disorders
Feeling hot
|
14.8%
4/27 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
20.0%
6/30 • Number of events 7 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
9.1%
3/33 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
12.5%
4/32 • Number of events 5 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
22.2%
6/27 • Number of events 6 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.7%
2/30 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Gastrointestinal disorders
Nuasea
|
7.4%
2/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
10.0%
3/30 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
18.2%
6/33 • Number of events 7 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
12.5%
4/32 • Number of events 5 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
22.2%
6/27 • Number of events 6 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
General disorders
Fatigue
|
51.9%
14/27 • Number of events 21 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
30.0%
9/30 • Number of events 13 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
33.3%
11/33 • Number of events 15 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
40.6%
13/32 • Number of events 18 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
33.3%
9/27 • Number of events 12 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
46.7%
14/30 • Number of events 19 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
General disorders
Injection site erythema
|
14.8%
4/27 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
30.0%
9/30 • Number of events 10 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
33.3%
11/33 • Number of events 12 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
37.5%
12/32 • Number of events 15 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
55.6%
15/27 • Number of events 16 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
36.7%
11/30 • Number of events 15 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
General disorders
Injection site haemorrhage
|
3.7%
1/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.7%
2/30 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.0%
1/33 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
9.4%
3/32 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.7%
1/27 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
10.0%
3/30 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
General disorders
Injection site induration
|
14.8%
4/27 • Number of events 5 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
33.3%
10/30 • Number of events 12 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
27.3%
9/33 • Number of events 9 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
25.0%
8/32 • Number of events 12 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
48.1%
13/27 • Number of events 19 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
16.7%
5/30 • Number of events 5 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
General disorders
Injection site pain
|
63.0%
17/27 • Number of events 27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
70.0%
21/30 • Number of events 31 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
45.5%
15/33 • Number of events 18 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
50.0%
16/32 • Number of events 23 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
63.0%
17/27 • Number of events 27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
50.0%
15/30 • Number of events 17 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
General disorders
Injection site pain (tenderness)
|
85.2%
23/27 • Number of events 43 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
93.3%
28/30 • Number of events 49 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
81.8%
27/33 • Number of events 33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
75.0%
24/32 • Number of events 41 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
96.3%
26/27 • Number of events 47 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
93.3%
28/30 • Number of events 32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
General disorders
Injection site pruritus
|
7.4%
2/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
10.0%
3/30 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
12.1%
4/33 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.2%
2/32 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
18.5%
5/27 • Number of events 6 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.7%
2/30 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
General disorders
Malaise
|
25.9%
7/27 • Number of events 9 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
16.7%
5/30 • Number of events 8 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
12.1%
4/33 • Number of events 5 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
18.8%
6/32 • Number of events 8 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
29.6%
8/27 • Number of events 9 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
16.7%
5/30 • Number of events 6 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Infections and infestations
Bronchitis
|
7.4%
2/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.1%
1/32 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.1%
2/33 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
3/27 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
10.0%
3/30 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.1%
2/33 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Infections and infestations
Rhinitis
|
7.4%
2/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.0%
1/33 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.2%
2/32 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.7%
2/30 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
10.0%
3/30 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
12.1%
4/33 • Number of events 5 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
9.4%
3/32 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.7%
1/27 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.1%
2/33 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.7%
2/30 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Investigations
Blood creatinine increased
|
3.7%
1/27 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
10.0%
3/30 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.0%
1/33 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.7%
1/27 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.1%
2/33 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.1%
1/32 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.7%
1/27 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Investigations
Hemoglobin decreased
|
11.1%
3/27 • Number of events 6 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
10.0%
3/30 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
9.1%
3/33 • Number of events 5 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
12.5%
4/32 • Number of events 9 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.7%
1/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.7%
2/30 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Investigations
Platelet count decreased
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
7.4%
2/27 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Investigations
Platelet count increased
|
3.7%
1/27 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.0%
1/33 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.1%
1/32 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
7.4%
2/27 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Investigations
White blood cell count decreased
|
11.1%
3/27 • Number of events 7 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
13.3%
4/30 • Number of events 7 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.1%
2/33 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
22.2%
6/27 • Number of events 9 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Investigations
White blood cell count increased
|
7.4%
2/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.0%
1/33 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.1%
1/32 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.7%
1/27 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
3/27 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
16.7%
5/30 • Number of events 7 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
9.1%
3/33 • Number of events 3 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
12.5%
4/32 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
11.1%
3/27 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
44.4%
12/27 • Number of events 18 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
33.3%
10/30 • Number of events 12 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
36.4%
12/33 • Number of events 12 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
25.0%
8/32 • Number of events 11 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
40.7%
11/27 • Number of events 14 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
36.7%
11/30 • Number of events 11 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Nervous system disorders
Headache
|
33.3%
9/27 • Number of events 9 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
20.0%
6/30 • Number of events 8 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
33.3%
11/33 • Number of events 12 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
25.0%
8/32 • Number of events 10 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
37.0%
10/27 • Number of events 13 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
20.0%
6/30 • Number of events 7 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Psychiatric disorders
Anxiety
|
3.7%
1/27 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.1%
2/33 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
9.1%
3/33 • Number of events 4 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.1%
1/32 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
7.4%
2/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
6.2%
2/32 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
3.3%
1/30 • Number of events 1 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/33 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/32 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
7.4%
2/27 • Number of events 2 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
0.00%
0/30 • Solicited events were collected from the time of each vaccination through 7 days after each vaccination. Unsolicited non-serious AEs were collected from the time of each vaccination through about 21 days after each vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of first vaccination through the final study visit, about 12 months after the last vaccination, totaling 13 or 16 months for those who received the second vaccine on day 21 or day 121, respectively.
Number of subjects at risk represent the number of subjects who received at least one study vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60