Trial Outcomes & Findings for A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years (NCT NCT03275389)
NCT ID: NCT03275389
Last Updated: 2021-05-07
Results Overview
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
470 participants
Primary outcome timeframe
During the 7-day (Days 1-7) follow-up period after first vaccine dose
Results posted on
2021-05-07
Participant Flow
470 subjects were enrolled and randomized in the study, however, while 2 subjects were allocated subjects numbers, they did not receive any vaccine dose.
Participant milestones
| Measure |
D-SUIV Adjuvanted Group 1
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
46
|
47
|
47
|
48
|
47
|
47
|
48
|
46
|
47
|
|
Overall Study
COMPLETED
|
34
|
30
|
24
|
25
|
32
|
29
|
22
|
30
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
23
|
22
|
16
|
18
|
25
|
18
|
15
|
18
|
Reasons for withdrawal
| Measure |
D-SUIV Adjuvanted Group 1
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
19
|
12
|
11
|
12
|
21
|
15
|
12
|
14
|
|
Overall Study
SERIOUS ADVERSE EVENT AND/OR PIMD
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT
|
1
|
0
|
0
|
5
|
3
|
3
|
3
|
3
|
2
|
2
|
|
Overall Study
MIGRATED / MOVED FROM THE STUDY AREA
|
0
|
2
|
0
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT WILLING TO PARTICIPATE THIS VISIT
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
4
|
3
|
2
|
2
|
2
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
Baseline characteristics by cohort
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=47 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
Total
n=468 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.0 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
29.3 Years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
28.6 Years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
28.7 Years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
29.1 Years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
28.8 Years
STANDARD_DEVIATION 6.1 • n=10 Participants
|
29.6 Years
STANDARD_DEVIATION 5.8 • n=115 Participants
|
28.5 Years
STANDARD_DEVIATION 5.9 • n=24 Participants
|
28.8 Years
STANDARD_DEVIATION 5.9 • n=42 Participants
|
29.3 Years
STANDARD_DEVIATION 5.8 • n=42 Participants
|
29.0 Years
STANDARD_DEVIATION 6.0 • n=42 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
268 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
22 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
200 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American indian or alaska native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - central / south asian heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - east asian heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - south east asian heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or african american
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
13 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
88 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native hawaiian or other pacific islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other, Not specified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White - arabic / north african heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White - caucasian / european heritage
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
33 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
359 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 1-7) follow-up period after first vaccine dosePopulation: Analysis was performed on the Exposed Set (ES) which included all subjects with the vaccine dose documented.
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=45 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration
Erythema
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration
Pain
|
34 Participants
|
42 Participants
|
37 Participants
|
39 Participants
|
40 Participants
|
42 Participants
|
16 Participants
|
13 Participants
|
15 Participants
|
35 Participants
|
|
Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration
Swelling
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 1-7) follow-up period after second vaccine dosePopulation: Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=37 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=36 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=38 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=39 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local AEs After Second Dose Administration
Swelling
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local AEs After Second Dose Administration
Erythema
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local AEs After Second Dose Administration
Pain
|
5 Participants
|
2 Participants
|
29 Participants
|
2 Participants
|
8 Participants
|
32 Participants
|
4 Participants
|
5 Participants
|
12 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 1-7) follow-up period after booster vaccine dosePopulation: Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 mm of injection site.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=32 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=27 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=31 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=24 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=32 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=31 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local AEs After Booster Dose Administration
Swelling
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local AEs After Booster Dose Administration
Erythema
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local AEs After Booster Dose Administration
Pain
|
27 Participants
|
31 Participants
|
26 Participants
|
29 Participants
|
28 Participants
|
25 Participants
|
4 Participants
|
10 Participants
|
13 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 1-7) follow-up period after first vaccine dosePopulation: Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=46 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General AEs After First Dose Administration
Temperature
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General AEs After First Dose Administration
Arthralgia
|
4 Participants
|
6 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Solicited General AEs After First Dose Administration
Fatigue
|
17 Participants
|
18 Participants
|
22 Participants
|
18 Participants
|
21 Participants
|
18 Participants
|
17 Participants
|
19 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Solicited General AEs After First Dose Administration
Gastrointestinal symptoms
|
6 Participants
|
7 Participants
|
10 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Solicited General AEs After First Dose Administration
Headache
|
18 Participants
|
18 Participants
|
19 Participants
|
23 Participants
|
16 Participants
|
26 Participants
|
16 Participants
|
19 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Solicited General AEs After First Dose Administration
Myalgia
|
16 Participants
|
13 Participants
|
19 Participants
|
17 Participants
|
19 Participants
|
20 Participants
|
9 Participants
|
9 Participants
|
6 Participants
|
11 Participants
|
|
Number of Subjects With Solicited General AEs After First Dose Administration
Shivering
|
6 Participants
|
3 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
9 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 1-7) follow-up period after second vaccine dosePopulation: Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=37 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=36 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=38 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General AEs After Second Dose Administration
Headache
|
8 Participants
|
12 Participants
|
13 Participants
|
7 Participants
|
9 Participants
|
12 Participants
|
5 Participants
|
12 Participants
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Solicited General AEs After Second Dose Administration
Temperature
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General AEs After Second Dose Administration
Arthralgia
|
3 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General AEs After Second Dose Administration
Fatigue
|
7 Participants
|
7 Participants
|
10 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
5 Participants
|
|
Number of Subjects With Solicited General AEs After Second Dose Administration
Gastrointestinal symptoms
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General AEs After Second Dose Administration
Myalgia
|
5 Participants
|
6 Participants
|
12 Participants
|
1 Participants
|
4 Participants
|
16 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General AEs After Second Dose Administration
Shivering
|
2 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 1-7) follow-up period after booster vaccine dosePopulation: Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=32 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=27 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=31 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=24 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=32 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=31 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General AEs After Booster Dose Administration
Fatigue
|
15 Participants
|
19 Participants
|
17 Participants
|
16 Participants
|
20 Participants
|
9 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General AEs After Booster Dose Administration
Gastrointestinal symptoms
|
3 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General AEs After Booster Dose Administration
Headache
|
9 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General AEs After Booster Dose Administration
Myalgia
|
15 Participants
|
17 Participants
|
15 Participants
|
15 Participants
|
13 Participants
|
10 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General AEs After Booster Dose Administration
Shivering
|
5 Participants
|
13 Participants
|
6 Participants
|
6 Participants
|
14 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General AEs After Booster Dose Administration
Temperature
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General AEs After Booster Dose Administration
Arthralgia
|
6 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 28-day (Days 1-28) follow-up period accross dosesPopulation: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=47 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited AEs Post-vaccination Period
|
27 Participants
|
23 Participants
|
23 Participants
|
24 Participants
|
24 Participants
|
17 Participants
|
22 Participants
|
23 Participants
|
22 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: At Day 8Population: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
Hematological parameters assessed are: Eosinophils increase \[EOSi\], hemoglobin decrease \[HEMd\] , lymphocytes decrease \[LYMd\], Neutrophils decrease \[NEUd\], platelets decrease \[PLTCd\], white blood cells decrease \[WBCd\], WBC increase \[WBCi\]. Biochemical parameters assessed are: alanine aminotransferase increase \[ALTi\], aspartate aminotransferase increase \[ASTi\], blood urea nitrogen \[BUN\], creatinine \[CRE\].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALT-Grade 0-Grade 1".
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=46 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ALTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ALTi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ALTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ALTi, GRADE 0, GRADE 0
|
40 Participants
|
45 Participants
|
42 Participants
|
41 Participants
|
45 Participants
|
45 Participants
|
43 Participants
|
44 Participants
|
41 Participants
|
44 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ALTi, GRADE 1, GRADE 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ASTi, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
CRE, GRADE 0, GRADE 0
|
44 Participants
|
46 Participants
|
45 Participants
|
43 Participants
|
46 Participants
|
46 Participants
|
43 Participants
|
47 Participants
|
45 Participants
|
45 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
EOSi, GRADE 0, UNKNOWN
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
EOSi, GRADE 0, GRADE 0
|
41 Participants
|
43 Participants
|
38 Participants
|
43 Participants
|
45 Participants
|
44 Participants
|
40 Participants
|
43 Participants
|
38 Participants
|
41 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
EOSi, GRADE 0, GRADE 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
EOSi, GRADE 1, GRADE 0
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 0, UNKNOWN
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 0, GRADE 0
|
37 Participants
|
37 Participants
|
40 Participants
|
39 Participants
|
43 Participants
|
40 Participants
|
37 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 0, GRADE 1
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 1, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 1, GRADE 1
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 1, GRADE 2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 2, GRADE 2
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 2, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 3, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
HEMd, GRADE 3, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
LYMd, UNKNOWN, GRADE 0
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
LYMd, GRADE 0, UNKNOWN
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
LYMd, GRADE 0, GRADE 0
|
39 Participants
|
45 Participants
|
37 Participants
|
44 Participants
|
43 Participants
|
45 Participants
|
42 Participants
|
42 Participants
|
38 Participants
|
41 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, UNKNOWN, GRADE 0
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
PLTCd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCd, GRADE 0, GRADE 0
|
41 Participants
|
45 Participants
|
42 Participants
|
44 Participants
|
44 Participants
|
46 Participants
|
41 Participants
|
42 Participants
|
41 Participants
|
43 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCd, GRADE 0, GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCi, GRADE 0, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCi, GRADE 1, GRADE 0
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCi, GRADE 1, GRADE 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCi, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
LYMd, GRADE 0, GRADE 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
LYMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
LYMd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
LYMd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, UNKNOWN, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 0, UNKNOWN
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 0, GRADE 0
|
37 Participants
|
40 Participants
|
39 Participants
|
41 Participants
|
41 Participants
|
43 Participants
|
39 Participants
|
38 Participants
|
37 Participants
|
37 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 0, GRADE 1
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 1, GRADE 0
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 1, GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
NEUd, GRADE 3, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
PLTCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
PLTCd, GRADE 0, UNKNOWN
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
PLTCd, GRADE 0, GRADE 0
|
43 Participants
|
45 Participants
|
42 Participants
|
43 Participants
|
46 Participants
|
45 Participants
|
42 Participants
|
44 Participants
|
43 Participants
|
43 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
PLTCd, GRADE 0, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
PLTCd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
PLTCd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
PLTCd, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCd, GRADE 0, UNKNOWN
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCd, GRADE 1, GRADE 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCi, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCi, GRADE 0, UNKNOWN
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
WBCi, GRADE 0, GRADE 0
|
41 Participants
|
43 Participants
|
42 Participants
|
42 Participants
|
45 Participants
|
45 Participants
|
39 Participants
|
39 Participants
|
38 Participants
|
39 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ALTi, GRADE 0, GRADE 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ALTi, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ALTi, GRADE 1, GRADE 0
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ASTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ASTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ASTi, GRADE 0, GRADE 0
|
44 Participants
|
46 Participants
|
44 Participants
|
42 Participants
|
46 Participants
|
45 Participants
|
42 Participants
|
44 Participants
|
44 Participants
|
44 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ASTi, GRADE 0, GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ASTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ASTi, GRADE 0, GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ASTi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
BUN, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
BUN, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
BUN, GRADE 0, GRADE 0
|
43 Participants
|
46 Participants
|
45 Participants
|
43 Participants
|
46 Participants
|
46 Participants
|
43 Participants
|
47 Participants
|
43 Participants
|
45 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
BUN, GRADE 1, GRADE 0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
EOSi, UNKNOWN, GRADE 0
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
BUN, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
CRE, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
CRE, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
EOSi, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 8 to Day 29Population: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=46 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 1
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 0
|
40 Participants
|
45 Participants
|
41 Participants
|
44 Participants
|
45 Participants
|
44 Participants
|
41 Participants
|
43 Participants
|
40 Participants
|
44 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, GRADE 1, GRADE 0
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ALTi, GRADE 1, GRADE 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 0
|
44 Participants
|
46 Participants
|
44 Participants
|
45 Participants
|
46 Participants
|
44 Participants
|
42 Participants
|
43 Participants
|
42 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ASTi, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
BUN, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
BUN, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 0
|
43 Participants
|
45 Participants
|
45 Participants
|
46 Participants
|
46 Participants
|
46 Participants
|
43 Participants
|
47 Participants
|
43 Participants
|
46 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
BUN, GRADE 1, GRADE 0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
BUN, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
CRE, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
CRE, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
CRE, GRADE 0, GRADE 0
|
44 Participants
|
46 Participants
|
45 Participants
|
46 Participants
|
46 Participants
|
46 Participants
|
43 Participants
|
47 Participants
|
45 Participants
|
46 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
EOSi, UNKNOWN, GRADE 0
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
EOSi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, GRADE 0
|
43 Participants
|
43 Participants
|
40 Participants
|
44 Participants
|
45 Participants
|
44 Participants
|
40 Participants
|
45 Participants
|
39 Participants
|
43 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, GRADE 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
EOSi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
EOSi, GRADE 1, GRADE 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 0
|
37 Participants
|
37 Participants
|
41 Participants
|
38 Participants
|
43 Participants
|
40 Participants
|
37 Participants
|
39 Participants
|
39 Participants
|
42 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 1
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 1
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 2
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
HEMd, GRADE 3, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, UNKNOWN, GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
PLTCd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 0
|
41 Participants
|
45 Participants
|
39 Participants
|
45 Participants
|
42 Participants
|
45 Participants
|
43 Participants
|
43 Participants
|
39 Participants
|
41 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
LYMd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 0
|
38 Participants
|
39 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
42 Participants
|
37 Participants
|
38 Participants
|
38 Participants
|
38 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 1
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 0
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
NEUd, GRADE 3, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
PLTCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 0
|
43 Participants
|
45 Participants
|
44 Participants
|
44 Participants
|
46 Participants
|
45 Participants
|
43 Participants
|
46 Participants
|
44 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
PLTCd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
PLTCd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCd, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 0
|
41 Participants
|
44 Participants
|
44 Participants
|
43 Participants
|
43 Participants
|
46 Participants
|
42 Participants
|
44 Participants
|
41 Participants
|
42 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 1
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCd, GRADE 1, GRADE 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCi, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 0
|
42 Participants
|
40 Participants
|
43 Participants
|
42 Participants
|
45 Participants
|
45 Participants
|
38 Participants
|
39 Participants
|
39 Participants
|
41 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 1
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
WBCi, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 8 to Day 85Population: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=46 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 0
|
41 Participants
|
41 Participants
|
39 Participants
|
44 Participants
|
40 Participants
|
44 Participants
|
43 Participants
|
41 Participants
|
38 Participants
|
40 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 1
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 0
|
37 Participants
|
35 Participants
|
40 Participants
|
36 Participants
|
37 Participants
|
39 Participants
|
37 Participants
|
35 Participants
|
36 Participants
|
37 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 1
|
4 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 0
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 1
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
PLTCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
PLTCd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
PLTCd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 0
|
41 Participants
|
43 Participants
|
44 Participants
|
41 Participants
|
41 Participants
|
46 Participants
|
42 Participants
|
42 Participants
|
40 Participants
|
41 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 1
|
2 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, GRADE 1, GRADE 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 0
|
41 Participants
|
39 Participants
|
42 Participants
|
39 Participants
|
45 Participants
|
44 Participants
|
36 Participants
|
39 Participants
|
38 Participants
|
39 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 1
|
1 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
WBCi, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 0
|
39 Participants
|
42 Participants
|
39 Participants
|
42 Participants
|
44 Participants
|
42 Participants
|
39 Participants
|
39 Participants
|
35 Participants
|
43 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 1
|
0 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, GRADE 1, GRADE 0
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, GRADE 1, GRADE 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ASTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 0
|
43 Participants
|
44 Participants
|
43 Participants
|
45 Participants
|
43 Participants
|
43 Participants
|
39 Participants
|
43 Participants
|
40 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 1
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 4
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ASTi, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ASTi, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
BUN, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
BUN, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 0
|
42 Participants
|
45 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
45 Participants
|
43 Participants
|
46 Participants
|
42 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
BUN, GRADE 1, GRADE 0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
BUN, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
CRE, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
CRE, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
CRE, GRADE 0, GRADE 0
|
44 Participants
|
46 Participants
|
45 Participants
|
46 Participants
|
46 Participants
|
46 Participants
|
43 Participants
|
47 Participants
|
45 Participants
|
46 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
EOSi, UNKNOWN, GRADE 0
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
EOSi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, GRADE 0
|
43 Participants
|
40 Participants
|
39 Participants
|
44 Participants
|
45 Participants
|
44 Participants
|
40 Participants
|
43 Participants
|
36 Participants
|
43 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, GRADE 1
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
NEUd, GRADE 3, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 0
|
42 Participants
|
45 Participants
|
44 Participants
|
43 Participants
|
46 Participants
|
45 Participants
|
43 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
PLTCd, GRADE 1, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
EOSi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
EOSi, GRADE 1, GRADE 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 0
|
37 Participants
|
34 Participants
|
41 Participants
|
35 Participants
|
42 Participants
|
37 Participants
|
37 Participants
|
39 Participants
|
39 Participants
|
40 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 1
|
2 Participants
|
7 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 1
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 2
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
HEMd, GRADE 3, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, UNKNOWN, GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ALTi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 8 to Month 14 + 28 daysPopulation: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=46 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 0
|
38 Participants
|
38 Participants
|
39 Participants
|
42 Participants
|
40 Participants
|
41 Participants
|
38 Participants
|
39 Participants
|
30 Participants
|
40 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 1
|
1 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
13 Participants
|
6 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, GRADE 1, GRADE 0
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ALTi, GRADE 1, GRADE 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 0
|
42 Participants
|
43 Participants
|
41 Participants
|
44 Participants
|
42 Participants
|
43 Participants
|
37 Participants
|
42 Participants
|
37 Participants
|
43 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 1
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 4
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
BUN, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
BUN, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 0
|
41 Participants
|
45 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
45 Participants
|
42 Participants
|
46 Participants
|
41 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
BUN, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
EOSi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 0
|
35 Participants
|
33 Participants
|
39 Participants
|
33 Participants
|
39 Participants
|
37 Participants
|
35 Participants
|
36 Participants
|
39 Participants
|
39 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 1
|
4 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ASTi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
BUN, GRADE 1, GRADE 0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
CRE, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
CRE, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
CRE, GRADE 0, GRADE 0
|
44 Participants
|
46 Participants
|
45 Participants
|
46 Participants
|
46 Participants
|
46 Participants
|
43 Participants
|
47 Participants
|
45 Participants
|
46 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
EOSi, UNKNOWN, GRADE 0
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
EOSi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
EOSi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
EOSi, GRADE 0, GRADE 0
|
42 Participants
|
40 Participants
|
39 Participants
|
43 Participants
|
45 Participants
|
44 Participants
|
39 Participants
|
42 Participants
|
34 Participants
|
43 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
EOSi, GRADE 0, GRADE 1
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
EOSi, GRADE 1, GRADE 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 1, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 1
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 2
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
HEMd, GRADE 3, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, UNKNOWN, GRADE 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 0
|
40 Participants
|
41 Participants
|
39 Participants
|
44 Participants
|
40 Participants
|
44 Participants
|
43 Participants
|
38 Participants
|
38 Participants
|
40 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 1
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
LYMd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 0
|
36 Participants
|
34 Participants
|
37 Participants
|
35 Participants
|
36 Participants
|
38 Participants
|
34 Participants
|
35 Participants
|
34 Participants
|
34 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 1
|
5 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 2
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 0
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
NEUd, GRADE 3, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
PLTCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 0
|
42 Participants
|
45 Participants
|
44 Participants
|
43 Participants
|
46 Participants
|
45 Participants
|
43 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
PLTCd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
PLTCd, GRADE 1, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
PLTCd, GRADE 2, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 0
|
41 Participants
|
42 Participants
|
41 Participants
|
40 Participants
|
41 Participants
|
46 Participants
|
42 Participants
|
41 Participants
|
38 Participants
|
41 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 1
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, GRADE 1, GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 0
|
39 Participants
|
39 Participants
|
40 Participants
|
37 Participants
|
43 Participants
|
43 Participants
|
35 Participants
|
37 Participants
|
36 Participants
|
36 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 1
|
3 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
WBCi, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 8 to Month 26Population: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=46 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, GRADE 1, GRADE 1
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, GRADE 1, GRADE 0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
CRE, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
EOSi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, GRADE 0
|
42 Participants
|
40 Participants
|
39 Participants
|
43 Participants
|
45 Participants
|
44 Participants
|
38 Participants
|
41 Participants
|
34 Participants
|
42 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
PLTCd, GRADE 2, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 0
|
38 Participants
|
38 Participants
|
39 Participants
|
42 Participants
|
40 Participants
|
39 Participants
|
37 Participants
|
38 Participants
|
29 Participants
|
40 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 1
|
1 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
14 Participants
|
6 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, GRADE 0, GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ALTi, GRADE 1, GRADE 0
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 0
|
42 Participants
|
42 Participants
|
41 Participants
|
44 Participants
|
42 Participants
|
42 Participants
|
36 Participants
|
42 Participants
|
37 Participants
|
43 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 1
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, GRADE 0, GRADE 4
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ASTi, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 1
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 2
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 1, GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 2, GRADE 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 3, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, UNKNOWN, GRADE 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 0
|
39 Participants
|
40 Participants
|
39 Participants
|
44 Participants
|
40 Participants
|
44 Participants
|
43 Participants
|
37 Participants
|
38 Participants
|
40 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 1
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 2
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 0, GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 1, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
LYMd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, UNKNOWN, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 0
|
35 Participants
|
34 Participants
|
37 Participants
|
35 Participants
|
36 Participants
|
36 Participants
|
34 Participants
|
35 Participants
|
34 Participants
|
34 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 1
|
5 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 0, GRADE 2
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 0
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 1, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 2, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
NEUd, GRADE 3, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
PLTCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 0
|
42 Participants
|
45 Participants
|
44 Participants
|
43 Participants
|
46 Participants
|
44 Participants
|
43 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
PLTCd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
PLTCd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
PLTCd, GRADE 1, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, UNKNOWN, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 0
|
39 Participants
|
42 Participants
|
41 Participants
|
40 Participants
|
41 Participants
|
46 Participants
|
42 Participants
|
41 Participants
|
38 Participants
|
41 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 1
|
4 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, GRADE 1, GRADE 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCd, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 0
|
37 Participants
|
38 Participants
|
40 Participants
|
37 Participants
|
43 Participants
|
43 Participants
|
35 Participants
|
37 Participants
|
36 Participants
|
36 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 1
|
5 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 1, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
WBCi, GRADE 2, GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 0
|
40 Participants
|
45 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
45 Participants
|
42 Participants
|
46 Participants
|
41 Participants
|
45 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, GRADE 0, GRADE 1
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
BUN, GRADE 2, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
CRE, UNKNOWN, GRADE 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
CRE, GRADE 0, GRADE 0
|
44 Participants
|
46 Participants
|
45 Participants
|
46 Participants
|
46 Participants
|
46 Participants
|
43 Participants
|
47 Participants
|
45 Participants
|
46 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
EOSi, UNKNOWN, GRADE 0
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, UNKNOWN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
EOSi, GRADE 0, GRADE 1
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
EOSi, GRADE 1, GRADE 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
EOSi, GRADE 1, GRADE 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, UNKNOWN, GRADE 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 0
|
33 Participants
|
32 Participants
|
37 Participants
|
31 Participants
|
38 Participants
|
36 Participants
|
35 Participants
|
35 Participants
|
37 Participants
|
39 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 1
|
5 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 2
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
HEMd, GRADE 0, GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 1 up to Month 26)Population: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
MAEs are defined as events for which the subject receives medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=47 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
|
21 Participants
|
16 Participants
|
20 Participants
|
23 Participants
|
21 Participants
|
14 Participants
|
19 Participants
|
18 Participants
|
23 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 1 up to Month 26)Population: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=47 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 1 up to Month 26)Population: Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=47 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At Day 1Population: Analysis of immunogenicity was performed on the Per-Protocol Set (PPS) which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 ELISA.Unit per milliliter (EL.U/mL).
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=45 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 1
|
45 Participants
|
46 Participants
|
47 Participants
|
47 Participants
|
48 Participants
|
47 Participants
|
47 Participants
|
46 Participants
|
44 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: At Day 29Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 29
|
43 Participants
|
40 Participants
|
41 Participants
|
40 Participants
|
42 Participants
|
42 Participants
|
37 Participants
|
41 Participants
|
39 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: At Day 85Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=38 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 85
|
39 Participants
|
36 Participants
|
34 Participants
|
35 Participants
|
39 Participants
|
35 Participants
|
34 Participants
|
34 Participants
|
35 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: At Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=45 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1
|
8887.9 EL.U/mL
Interval 7004.9 to 11277.1
|
8719.3 EL.U/mL
Interval 6547.0 to 11612.3
|
9691 EL.U/mL
Interval 7593.7 to 12367.7
|
9121 EL.U/mL
Interval 7180.0 to 11586.6
|
9948.6 EL.U/mL
Interval 8106.2 to 12209.8
|
8555.5 EL.U/mL
Interval 6980.1 to 10486.4
|
9019.6 EL.U/mL
Interval 7263.5 to 11200.2
|
9278.2 EL.U/mL
Interval 7430.7 to 11585.1
|
9039.3 EL.U/mL
Interval 6930.7 to 11789.5
|
9160 EL.U/mL
Interval 7225.7 to 11612.2
|
PRIMARY outcome
Timeframe: At Day 29Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29
|
112973.2 EL.U/mL
Interval 90888.2 to 140424.5
|
45645 EL.U/mL
Interval 35289.4 to 59039.5
|
116596.8 EL.U/mL
Interval 93869.6 to 144826.6
|
61634.2 EL.U/mL
Interval 49810.3 to 76264.7
|
46596.2 EL.U/mL
Interval 38306.7 to 56679.5
|
67114.6 EL.U/mL
Interval 54649.7 to 82422.6
|
35580.2 EL.U/mL
Interval 24654.2 to 51348.2
|
20398.6 EL.U/mL
Interval 16362.4 to 25430.5
|
36426.2 EL.U/mL
Interval 29124.8 to 45558.0
|
21938.1 EL.U/mL
Interval 18037.8 to 26681.8
|
PRIMARY outcome
Timeframe: At Day 85Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=38 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85
|
45351.6 EL.U/mL
Interval 36766.7 to 55941.1
|
28437.5 EL.U/mL
Interval 21623.4 to 37398.9
|
74639.7 EL.U/mL
Interval 59986.3 to 92872.6
|
30419.3 EL.U/mL
Interval 23619.9 to 39176.0
|
25718.6 EL.U/mL
Interval 20748.8 to 31878.8
|
48775.9 EL.U/mL
Interval 40697.7 to 58457.7
|
28617.8 EL.U/mL
Interval 19448.1 to 42110.9
|
15105.9 EL.U/mL
Interval 12007.7 to 19003.6
|
37911.4 EL.U/mL
Interval 30149.4 to 47671.7
|
16749.9 EL.U/mL
Interval 13471.8 to 20825.8
|
PRIMARY outcome
Timeframe: At Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H1 stalk immune response measured by MN are expressed in 1/DILUTION (DIL). The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=44 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=44 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=43 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=41 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 1
|
32 Participants
|
34 Participants
|
35 Participants
|
36 Participants
|
33 Participants
|
40 Participants
|
37 Participants
|
34 Participants
|
31 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: At Day 29Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 29
|
43 Participants
|
40 Participants
|
40 Participants
|
40 Participants
|
41 Participants
|
41 Participants
|
36 Participants
|
41 Participants
|
37 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: At Day 85Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=38 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=38 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 85
|
36 Participants
|
35 Participants
|
34 Participants
|
31 Participants
|
38 Participants
|
35 Participants
|
30 Participants
|
32 Participants
|
35 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: At Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=44 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=44 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=43 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=41 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1
|
40.6 Titer
Interval 29.4 to 56.1
|
45.4 Titer
Interval 33.4 to 61.6
|
45.9 Titer
Interval 34.2 to 61.8
|
45.8 Titer
Interval 34.5 to 60.8
|
41.9 Titer
Interval 30.7 to 57.3
|
45.1 Titer
Interval 35.0 to 58.2
|
44.6 Titer
Interval 34.4 to 57.7
|
43.4 Titer
Interval 32.4 to 58.0
|
42.7 Titer
Interval 31.2 to 58.6
|
38 Titer
Interval 28.8 to 50.2
|
PRIMARY outcome
Timeframe: At Day 29Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29
|
100.3 Titer
Interval 88.1 to 114.1
|
109.3 Titer
Interval 94.0 to 127.0
|
113.1 Titer
Interval 96.5 to 132.6
|
105.6 Titer
Interval 91.0 to 122.5
|
96.4 Titer
Interval 83.2 to 111.6
|
89.8 Titer
Interval 73.0 to 110.5
|
86.2 Titer
Interval 69.9 to 106.3
|
80 Titer
Interval 66.6 to 96.1
|
74.5 Titer
Interval 59.6 to 93.2
|
87.2 Titer
Interval 75.6 to 100.7
|
PRIMARY outcome
Timeframe: At Day 85Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=38 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=38 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85
|
73 Titer
Interval 58.3 to 91.5
|
98.9 Titer
Interval 81.5 to 119.9
|
122.7 Titer
Interval 108.9 to 138.3
|
59.6 Titer
Interval 45.9 to 77.4
|
87.4 Titer
Interval 71.1 to 107.6
|
109.8 Titer
Interval 93.0 to 129.8
|
55.4 Titer
Interval 41.3 to 74.3
|
75.3 Titer
Interval 56.4 to 100.4
|
88.3 Titer
Interval 74.2 to 105.2
|
86.1 Titer
Interval 70.2 to 105.5
|
PRIMARY outcome
Timeframe: At Day 29, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with an equal or greater than (≥) 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
|
88.4 Percentage of subjects
Interval 74.9 to 96.1
|
60 Percentage of subjects
Interval 43.3 to 75.1
|
87.8 Percentage of subjects
Interval 73.8 to 95.9
|
70 Percentage of subjects
Interval 53.5 to 83.4
|
52.4 Percentage of subjects
Interval 36.4 to 68.0
|
83.3 Percentage of subjects
Interval 68.6 to 93.0
|
35.1 Percentage of subjects
Interval 20.2 to 52.5
|
24.4 Percentage of subjects
Interval 12.4 to 40.3
|
38.5 Percentage of subjects
Interval 23.4 to 55.4
|
15 Percentage of subjects
Interval 5.7 to 29.8
|
PRIMARY outcome
Timeframe: At Day 85, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=38 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
|
51.3 Percentage of subjects
Interval 34.8 to 67.6
|
44.4 Percentage of subjects
Interval 27.9 to 61.9
|
79.4 Percentage of subjects
Interval 62.1 to 91.3
|
37.1 Percentage of subjects
Interval 21.5 to 55.1
|
20.5 Percentage of subjects
Interval 9.3 to 36.5
|
80 Percentage of subjects
Interval 63.1 to 91.6
|
29.4 Percentage of subjects
Interval 15.1 to 47.5
|
8.8 Percentage of subjects
Interval 1.9 to 23.7
|
37.1 Percentage of subjects
Interval 21.5 to 55.1
|
7.9 Percentage of subjects
Interval 1.7 to 21.4
|
PRIMARY outcome
Timeframe: At Day 29, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=38 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=36 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29
|
40.5 Percentage of subjects
Interval 25.6 to 56.7
|
39.5 Percentage of subjects
Interval 24.0 to 56.6
|
31.6 Percentage of subjects
Interval 17.5 to 48.7
|
41 Percentage of subjects
Interval 25.6 to 57.9
|
36.8 Percentage of subjects
Interval 21.8 to 54.0
|
31.7 Percentage of subjects
Interval 18.1 to 48.1
|
34.3 Percentage of subjects
Interval 19.1 to 52.2
|
26.3 Percentage of subjects
Interval 13.4 to 43.1
|
29.7 Percentage of subjects
Interval 15.9 to 47.0
|
36.1 Percentage of subjects
Interval 20.8 to 53.8
|
PRIMARY outcome
Timeframe: At Day 85, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=32 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=35 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=32 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=34 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85
|
29.7 Percentage of subjects
Interval 15.9 to 47.0
|
38.2 Percentage of subjects
Interval 22.2 to 56.4
|
34.4 Percentage of subjects
Interval 18.6 to 53.2
|
15.2 Percentage of subjects
Interval 5.1 to 31.9
|
31.4 Percentage of subjects
Interval 16.9 to 49.3
|
41.2 Percentage of subjects
Interval 24.6 to 59.3
|
21.2 Percentage of subjects
Interval 9.0 to 38.9
|
18.8 Percentage of subjects
Interval 7.2 to 36.4
|
33.3 Percentage of subjects
Interval 18.0 to 51.8
|
41.2 Percentage of subjects
Interval 24.6 to 59.3
|
PRIMARY outcome
Timeframe: At Day 29, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
|
58.1 Percentage of subjects
Interval 42.1 to 73.0
|
35 Percentage of subjects
Interval 20.6 to 51.7
|
61 Percentage of subjects
Interval 44.5 to 75.8
|
30 Percentage of subjects
Interval 16.6 to 46.5
|
21.4 Percentage of subjects
Interval 10.3 to 36.8
|
42.9 Percentage of subjects
Interval 27.7 to 59.0
|
13.5 Percentage of subjects
Interval 4.5 to 28.8
|
2.4 Percentage of subjects
Interval 0.1 to 12.9
|
15.4 Percentage of subjects
Interval 5.9 to 30.5
|
2.5 Percentage of subjects
Interval 0.1 to 13.2
|
PRIMARY outcome
Timeframe: At Day 85, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=38 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
|
12.8 Percentage of subjects
Interval 4.3 to 27.4
|
5.6 Percentage of subjects
Interval 0.7 to 18.7
|
47.1 Percentage of subjects
Interval 29.8 to 64.9
|
17.1 Percentage of subjects
Interval 6.6 to 33.6
|
5.1 Percentage of subjects
Interval 0.6 to 17.3
|
25.7 Percentage of subjects
Interval 12.5 to 43.3
|
17.6 Percentage of subjects
Interval 6.8 to 34.5
|
2.9 Percentage of subjects
Interval 0.1 to 15.3
|
14.3 Percentage of subjects
Interval 4.8 to 30.3
|
5.3 Percentage of subjects
Interval 0.6 to 17.7
|
PRIMARY outcome
Timeframe: At Day 29, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=38 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=36 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29
|
7.1 Percentage of subjects
Interval 1.5 to 19.5
|
7.9 Percentage of subjects
Interval 1.7 to 21.4
|
10.5 Percentage of subjects
Interval 2.9 to 24.8
|
5.1 Percentage of subjects
Interval 0.6 to 17.3
|
7.9 Percentage of subjects
Interval 1.7 to 21.4
|
4.9 Percentage of subjects
Interval 0.6 to 16.5
|
8.6 Percentage of subjects
Interval 1.8 to 23.1
|
2.6 Percentage of subjects
Interval 0.1 to 13.8
|
2.7 Percentage of subjects
Interval 0.1 to 14.2
|
2.8 Percentage of subjects
Interval 0.1 to 14.5
|
PRIMARY outcome
Timeframe: At Day 85, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=32 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=35 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=32 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=34 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85
|
2.7 Percentage of subjects
Interval 0.1 to 14.2
|
8.8 Percentage of subjects
Interval 1.9 to 23.7
|
15.6 Percentage of subjects
Interval 5.3 to 32.8
|
3 Percentage of subjects
Interval 0.1 to 15.8
|
8.6 Percentage of subjects
Interval 1.8 to 23.1
|
8.8 Percentage of subjects
Interval 1.9 to 23.7
|
0 Percentage of subjects
Interval 0.0 to 10.6
|
6.3 Percentage of subjects
Interval 0.8 to 20.8
|
3 Percentage of subjects
Interval 0.1 to 15.8
|
2.9 Percentage of subjects
Interval 0.1 to 15.3
|
PRIMARY outcome
Timeframe: At Day 29, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
|
12.4 Ratio
Interval 9.2 to 16.7
|
5.9 Ratio
Interval 4.4 to 8.0
|
12.6 Ratio
Interval 9.2 to 17.1
|
6.8 Ratio
Interval 4.9 to 9.5
|
4.7 Ratio
Interval 3.6 to 6.2
|
8.1 Ratio
Interval 6.2 to 10.5
|
4.2 Ratio
Interval 2.9 to 6.2
|
2.3 Ratio
Interval 1.8 to 3.0
|
3.9 Ratio
Interval 2.8 to 5.4
|
2.4 Ratio
Interval 1.9 to 2.9
|
PRIMARY outcome
Timeframe: At Day 85, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=39 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=38 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
|
5 Ratio
Interval 3.9 to 6.5
|
3.4 Ratio
Interval 2.6 to 4.5
|
8.1 Ratio
Interval 6.1 to 10.8
|
3.4 Ratio
Interval 2.4 to 4.9
|
2.6 Ratio
Interval 2.1 to 3.2
|
6.3 Ratio
Interval 5.0 to 7.9
|
3.4 Ratio
Interval 2.3 to 5.0
|
1.7 Ratio
Interval 1.4 to 2.1
|
3.8 Ratio
Interval 2.7 to 5.5
|
1.8 Ratio
Interval 1.5 to 2.3
|
PRIMARY outcome
Timeframe: At Day 29, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=38 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=38 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=36 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29
|
2.4 Ratio
Interval 1.7 to 3.3
|
2.6 Ratio
Interval 1.9 to 3.6
|
2.4 Ratio
Interval 1.8 to 3.3
|
2.3 Ratio
Interval 1.7 to 3.2
|
2.3 Ratio
Interval 1.7 to 3.2
|
2 Ratio
Interval 1.5 to 2.7
|
2.3 Ratio
Interval 1.7 to 3.2
|
1.9 Ratio
Interval 1.4 to 2.5
|
1.7 Ratio
Interval 1.2 to 2.4
|
2.2 Ratio
Interval 1.6 to 3.1
|
PRIMARY outcome
Timeframe: At Day 85, compared to pre-vaccination at Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=32 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=35 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=32 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=34 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85
|
1.6 Ratio
Interval 1.2 to 2.2
|
2.2 Ratio
Interval 1.5 to 3.2
|
2.5 Ratio
Interval 1.7 to 3.7
|
1.1 Ratio
Interval 0.8 to 1.6
|
2 Ratio
Interval 1.5 to 2.8
|
2.5 Ratio
Interval 1.7 to 3.5
|
1.2 Ratio
Interval 0.9 to 1.7
|
1.6 Ratio
Interval 1.1 to 2.2
|
2 Ratio
Interval 1.4 to 2.8
|
2.4 Ratio
Interval 1.7 to 3.3
|
SECONDARY outcome
Timeframe: 28 days post priming dose(s) i.e. at Day 29 for 1 priming dose groups and at Day 85 for 2 priming doses groupsPopulation: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
The adjusted GMCs are presented to evaluate the adjuvant effect post-dose 1 and post-dose 2.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=34 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=35 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA
|
112206.4 EL.U/mL
Interval 91362.2 to 137806.3
|
47432.6 EL.U/mL
Interval 38317.4 to 58716.2
|
73945.6 EL.U/mL
Interval 58686.6 to 93172.2
|
61356.7 EL.U/mL
Interval 49582.3 to 75927.0
|
45346.6 EL.U/mL
Interval 36827.0 to 55837.2
|
50602.8 EL.U/mL
Interval 40283.4 to 63565.8
|
36159.3 EL.U/mL
Interval 28972.3 to 45129.0
|
20403.5 EL.U/mL
Interval 16531.4 to 25182.7
|
36826.9 EL.U/mL
Interval 29320.0 to 46255.8
|
21675.2 EL.U/mL
Interval 17515.2 to 26823.1
|
SECONDARY outcome
Timeframe: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=27 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=34 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M8
|
27068.3 EL.U/mL
Interval 21884.3 to 33480.4
|
17155.9 EL.U/mL
Interval 13158.7 to 22367.4
|
41759.7 EL.U/mL
Interval 32814.0 to 53144.1
|
18915.3 EL.U/mL
Interval 15026.4 to 23810.7
|
15092.4 EL.U/mL
Interval 12226.1 to 18630.8
|
25279.1 EL.U/mL
Interval 20711.4 to 30854.2
|
19028.4 EL.U/mL
Interval 13706.8 to 26416.0
|
11024.8 EL.U/mL
Interval 8751.5 to 13888.6
|
22359.8 EL.U/mL
Interval 18089.1 to 27638.8
|
13142.1 EL.U/mL
Interval 10306.0 to 16758.7
|
|
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M14
|
22687.1 EL.U/mL
Interval 18078.5 to 28470.4
|
17662.4 EL.U/mL
Interval 14339.6 to 21755.1
|
37282.2 EL.U/mL
Interval 29437.7 to 47216.9
|
20146.8 EL.U/mL
Interval 15305.9 to 26518.8
|
16645.4 EL.U/mL
Interval 12389.7 to 22362.8
|
24615 EL.U/mL
Interval 19677.5 to 30791.4
|
16969.8 EL.U/mL
Interval 11848.5 to 24304.6
|
10820.3 EL.U/mL
Interval 8524.9 to 13733.9
|
22791.5 EL.U/mL
Interval 17767.3 to 29236.4
|
12458.4 EL.U/mL
Interval 9721.6 to 15965.7
|
|
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M14+28 days
|
49594 EL.U/mL
Interval 39888.4 to 61661.1
|
92885.6 EL.U/mL
Interval 73985.7 to 116613.7
|
73078 EL.U/mL
Interval 62288.9 to 85736.0
|
36709.7 EL.U/mL
Interval 30186.1 to 44643.2
|
75155.7 EL.U/mL
Interval 56729.2 to 99567.4
|
52026.4 EL.U/mL
Interval 42254.7 to 64057.8
|
22653.6 EL.U/mL
Interval 16071.5 to 31931.4
|
29508.2 EL.U/mL
Interval 21062.2 to 41341.1
|
38364 EL.U/mL
Interval 30403.9 to 48408.1
|
17593.3 EL.U/mL
Interval 13932.1 to 22216.6
|
|
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M20
|
27648.6 EL.U/mL
Interval 22712.3 to 33657.7
|
36133.6 EL.U/mL
Interval 29063.7 to 44923.2
|
38120.3 EL.U/mL
Interval 30433.7 to 47748.2
|
21916.1 EL.U/mL
Interval 17219.1 to 27894.4
|
31396.4 EL.U/mL
Interval 24953.9 to 39502.2
|
29988.8 EL.U/mL
Interval 24033.9 to 37419.1
|
18408.1 EL.U/mL
Interval 12608.3 to 26875.7
|
16632.9 EL.U/mL
Interval 12484.8 to 22159.2
|
23145.3 EL.U/mL
Interval 18447.2 to 29039.9
|
12635.2 EL.U/mL
Interval 9489.2 to 16824.1
|
|
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M26
|
22850.2 EL.U/mL
Interval 18790.0 to 27787.8
|
29027.2 EL.U/mL
Interval 23343.2 to 36095.3
|
32635.4 EL.U/mL
Interval 26013.9 to 40942.3
|
18266 EL.U/mL
Interval 14093.9 to 23673.1
|
27491.3 EL.U/mL
Interval 20448.3 to 36960.2
|
25059.4 EL.U/mL
Interval 19893.4 to 31567.0
|
18220.9 EL.U/mL
Interval 12067.9 to 27511.0
|
14269 EL.U/mL
Interval 10104.9 to 20149.0
|
21673.7 EL.U/mL
Interval 17482.9 to 26869.2
|
12050.6 EL.U/mL
Interval 8943.4 to 16237.5
|
SECONDARY outcome
Timeframe: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=27 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=34 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M20
|
29 Participants
|
30 Participants
|
24 Participants
|
24 Participants
|
31 Participants
|
27 Participants
|
20 Participants
|
27 Participants
|
27 Participants
|
25 Participants
|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M8
|
39 Participants
|
34 Participants
|
30 Participants
|
27 Participants
|
36 Participants
|
33 Participants
|
30 Participants
|
34 Participants
|
33 Participants
|
34 Participants
|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M14
|
35 Participants
|
32 Participants
|
26 Participants
|
26 Participants
|
31 Participants
|
31 Participants
|
25 Participants
|
30 Participants
|
30 Participants
|
31 Participants
|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M14+28 days
|
28 Participants
|
31 Participants
|
23 Participants
|
25 Participants
|
29 Participants
|
29 Participants
|
22 Participants
|
26 Participants
|
27 Participants
|
29 Participants
|
|
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
M26
|
29 Participants
|
29 Participants
|
22 Participants
|
21 Participants
|
25 Participants
|
25 Participants
|
20 Participants
|
25 Participants
|
25 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=27 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=34 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M20
|
27.6 Percentage of subjects
Interval 12.7 to 47.2
|
60 Percentage of subjects
Interval 40.6 to 77.3
|
50 Percentage of subjects
Interval 29.1 to 70.9
|
33.3 Percentage of subjects
Interval 15.6 to 55.3
|
38.7 Percentage of subjects
Interval 21.8 to 57.8
|
48.1 Percentage of subjects
Interval 28.7 to 68.1
|
20 Percentage of subjects
Interval 5.7 to 43.7
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
25.9 Percentage of subjects
Interval 11.1 to 46.3
|
0 Percentage of subjects
Interval 0.0 to 13.7
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M26
|
20.7 Percentage of subjects
Interval 8.0 to 39.7
|
41.4 Percentage of subjects
Interval 23.5 to 61.1
|
36.4 Percentage of subjects
Interval 17.2 to 59.3
|
28.6 Percentage of subjects
Interval 11.3 to 52.2
|
32 Percentage of subjects
Interval 14.9 to 53.5
|
36 Percentage of subjects
Interval 18.0 to 57.5
|
15 Percentage of subjects
Interval 3.2 to 37.9
|
8 Percentage of subjects
Interval 1.0 to 26.0
|
24 Percentage of subjects
Interval 9.4 to 45.1
|
0 Percentage of subjects
Interval 0.0 to 14.8
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M8
|
23.1 Percentage of subjects
Interval 11.1 to 39.3
|
23.5 Percentage of subjects
Interval 10.7 to 41.2
|
53.3 Percentage of subjects
Interval 34.3 to 71.7
|
14.8 Percentage of subjects
Interval 4.2 to 33.7
|
5.6 Percentage of subjects
Interval 0.7 to 18.7
|
39.4 Percentage of subjects
Interval 22.9 to 57.9
|
23.3 Percentage of subjects
Interval 9.9 to 42.3
|
8.8 Percentage of subjects
Interval 1.9 to 23.7
|
21.2 Percentage of subjects
Interval 9.0 to 38.9
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M14
|
20 Percentage of subjects
Interval 8.4 to 36.9
|
25 Percentage of subjects
Interval 11.5 to 43.4
|
50 Percentage of subjects
Interval 29.9 to 70.1
|
30.8 Percentage of subjects
Interval 14.3 to 51.8
|
9.7 Percentage of subjects
Interval 2.0 to 25.8
|
38.7 Percentage of subjects
Interval 21.8 to 57.8
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
3.3 Percentage of subjects
Interval 0.1 to 17.2
|
13.3 Percentage of subjects
Interval 3.8 to 30.7
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M14+28 days
|
46.4 Percentage of subjects
Interval 27.5 to 66.1
|
83.9 Percentage of subjects
Interval 66.3 to 94.5
|
82.6 Percentage of subjects
Interval 61.2 to 95.0
|
44 Percentage of subjects
Interval 24.4 to 65.1
|
69 Percentage of subjects
Interval 49.2 to 84.7
|
75.9 Percentage of subjects
Interval 56.5 to 89.7
|
22.7 Percentage of subjects
Interval 7.8 to 45.4
|
38.5 Percentage of subjects
Interval 20.2 to 59.4
|
33.3 Percentage of subjects
Interval 16.5 to 54.0
|
10.3 Percentage of subjects
Interval 2.2 to 27.4
|
SECONDARY outcome
Timeframe: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=27 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=34 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M8
|
7.7 Percentage of subjects
Interval 1.6 to 20.9
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
23.3 Percentage of subjects
Interval 9.9 to 42.3
|
7.4 Percentage of subjects
Interval 0.9 to 24.3
|
0 Percentage of subjects
Interval 0.0 to 9.7
|
9.1 Percentage of subjects
Interval 1.9 to 24.3
|
10 Percentage of subjects
Interval 2.1 to 26.5
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
9.1 Percentage of subjects
Interval 1.9 to 24.3
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M14
|
5.7 Percentage of subjects
Interval 0.7 to 19.2
|
3.1 Percentage of subjects
Interval 0.1 to 16.2
|
30.8 Percentage of subjects
Interval 14.3 to 51.8
|
3.8 Percentage of subjects
Interval 0.1 to 19.6
|
3.2 Percentage of subjects
Interval 0.1 to 16.7
|
3.2 Percentage of subjects
Interval 0.1 to 16.7
|
4 Percentage of subjects
Interval 0.1 to 20.4
|
0 Percentage of subjects
Interval 0.0 to 11.6
|
10 Percentage of subjects
Interval 2.1 to 26.5
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M14+28 days
|
17.9 Percentage of subjects
Interval 6.1 to 36.9
|
58.1 Percentage of subjects
Interval 39.1 to 75.5
|
52.2 Percentage of subjects
Interval 30.6 to 73.2
|
24 Percentage of subjects
Interval 9.4 to 45.1
|
37.9 Percentage of subjects
Interval 20.7 to 57.7
|
34.5 Percentage of subjects
Interval 17.9 to 54.3
|
4.5 Percentage of subjects
Interval 0.1 to 22.8
|
11.5 Percentage of subjects
Interval 2.4 to 30.2
|
18.5 Percentage of subjects
Interval 6.3 to 38.1
|
0 Percentage of subjects
Interval 0.0 to 11.9
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M20
|
10.3 Percentage of subjects
Interval 2.2 to 27.4
|
26.7 Percentage of subjects
Interval 12.3 to 45.9
|
16.7 Percentage of subjects
Interval 4.7 to 37.4
|
8.3 Percentage of subjects
Interval 1.0 to 27.0
|
9.7 Percentage of subjects
Interval 2.0 to 25.8
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
5 Percentage of subjects
Interval 0.1 to 24.9
|
3.7 Percentage of subjects
Interval 0.1 to 19.0
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
0 Percentage of subjects
Interval 0.0 to 13.7
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
M26
|
3.4 Percentage of subjects
Interval 0.1 to 17.8
|
13.8 Percentage of subjects
Interval 3.9 to 31.7
|
4.5 Percentage of subjects
Interval 0.1 to 22.8
|
4.8 Percentage of subjects
Interval 0.1 to 23.8
|
4 Percentage of subjects
Interval 0.1 to 20.4
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
10 Percentage of subjects
Interval 1.2 to 31.7
|
4 Percentage of subjects
Interval 0.1 to 20.4
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
0 Percentage of subjects
Interval 0.0 to 14.8
|
SECONDARY outcome
Timeframe: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=27 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=36 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=30 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=34 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=33 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=34 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26
M8
|
2.9 Ratio
Interval 2.2 to 3.7
|
2.3 Ratio
Interval 1.8 to 2.9
|
4.7 Ratio
Interval 3.5 to 6.3
|
2 Ratio
Interval 1.4 to 2.8
|
1.4 Ratio
Interval 1.2 to 1.8
|
3.3 Ratio
Interval 2.6 to 4.3
|
2.2 Ratio
Interval 1.5 to 3.1
|
1.3 Ratio
Interval 1.1 to 1.7
|
2.4 Ratio
Interval 1.7 to 3.3
|
1.3 Ratio
Interval 1.1 to 1.5
|
|
MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26
M14
|
2.5 Ratio
Interval 2.0 to 3.2
|
2.4 Ratio
Interval 1.8 to 3.2
|
4.7 Ratio
Interval 3.2 to 6.8
|
2.3 Ratio
Interval 1.7 to 3.2
|
1.6 Ratio
Interval 1.2 to 2.1
|
3.2 Ratio
Interval 2.5 to 4.2
|
2 Ratio
Interval 1.4 to 2.8
|
1.2 Ratio
Interval 1.0 to 1.5
|
2.1 Ratio
Interval 1.4 to 3.1
|
1.2 Ratio
Interval 1.0 to 1.4
|
|
MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26
M14+28 days
|
5.3 Ratio
Interval 3.7 to 7.7
|
12.6 Ratio
Interval 8.7 to 18.2
|
9.5 Ratio
Interval 6.6 to 13.6
|
4.3 Ratio
Interval 3.0 to 6.4
|
7.3 Ratio
Interval 5.0 to 10.7
|
7.1 Ratio
Interval 5.3 to 9.5
|
2.7 Ratio
Interval 2.0 to 3.8
|
3.4 Ratio
Interval 2.3 to 5.0
|
4.1 Ratio
Interval 2.6 to 6.3
|
1.7 Ratio
Interval 1.3 to 2.2
|
|
MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26
M20
|
3 Ratio
Interval 2.3 to 3.8
|
4.9 Ratio
Interval 3.5 to 6.8
|
4.6 Ratio
Interval 3.3 to 6.3
|
2.6 Ratio
Interval 1.8 to 3.8
|
3.1 Ratio
Interval 2.3 to 4.1
|
4 Ratio
Interval 3.0 to 5.3
|
2.2 Ratio
Interval 1.5 to 3.2
|
1.8 Ratio
Interval 1.4 to 2.3
|
2.5 Ratio
Interval 1.7 to 3.6
|
1.3 Ratio
Interval 1.1 to 1.6
|
|
MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26
M26
|
2.7 Ratio
Interval 2.0 to 3.5
|
3.7 Ratio
Interval 2.7 to 5.2
|
3.7 Ratio
Interval 2.7 to 5.2
|
2.3 Ratio
Interval 1.5 to 3.6
|
2.6 Ratio
Interval 1.9 to 3.7
|
3.3 Ratio
Interval 2.4 to 4.4
|
2.1 Ratio
Interval 1.4 to 3.3
|
1.5 Ratio
Interval 1.1 to 2.1
|
2.2 Ratio
Interval 1.5 to 3.3
|
1.3 Ratio
Interval 1.1 to 1.6
|
SECONDARY outcome
Timeframe: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=45 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M8
|
29904.9 EL.U/mL
Interval 24015.3 to 37238.9
|
12923.2 EL.U/mL
Interval 9816.8 to 17012.6
|
38258.4 EL.U/mL
Interval 29536.3 to 49556.3
|
18259.9 EL.U/mL
Interval 13789.8 to 24179.0
|
12402.4 EL.U/mL
Interval 9535.4 to 16131.4
|
24555.6 EL.U/mL
Interval 19235.1 to 31347.7
|
19264.5 EL.U/mL
Interval 13044.6 to 28450.1
|
8229 EL.U/mL
Interval 6456.6 to 10488.1
|
22379.6 EL.U/mL
Interval 17763.5 to 28195.2
|
9409 EL.U/mL
Interval 7202.0 to 12292.4
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M14+28 days
|
36459.1 EL.U/mL
Interval 29419.5 to 45183.3
|
91778 EL.U/mL
Interval 73053.9 to 115301.3
|
76909.5 EL.U/mL
Interval 63594.4 to 93012.4
|
27256.3 EL.U/mL
Interval 20573.9 to 36109.3
|
81616.2 EL.U/mL
Interval 64374.2 to 103476.4
|
58542.1 EL.U/mL
Interval 47219.6 to 72579.5
|
19172.9 EL.U/mL
Interval 12543.2 to 29306.6
|
29940.3 EL.U/mL
Interval 20765.3 to 43169.3
|
41953 EL.U/mL
Interval 34398.2 to 51167.0
|
11753.1 EL.U/mL
Interval 9023.9 to 15307.8
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M8
|
11992.9 EL.U/mL
Interval 9665.8 to 14880.2
|
10240.6 EL.U/mL
Interval 7932.7 to 13220.0
|
18529.9 EL.U/mL
Interval 15273.7 to 22480.4
|
10260.8 EL.U/mL
Interval 8094.5 to 13006.8
|
9973.8 EL.U/mL
Interval 7709.1 to 12903.9
|
12753.8 EL.U/mL
Interval 10434.4 to 15588.8
|
9988.8 EL.U/mL
Interval 7297.7 to 13672.3
|
8182.1 EL.U/mL
Interval 6517.6 to 10271.7
|
12617.3 EL.U/mL
Interval 10198.5 to 15609.8
|
9590.3 EL.U/mL
Interval 7160.5 to 12844.6
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M26
|
10832.8 EL.U/mL
Interval 8488.3 to 13825.0
|
11823.4 EL.U/mL
Interval 9575.2 to 14599.4
|
12186.4 EL.U/mL
Interval 9948.2 to 14928.2
|
9767.9 EL.U/mL
Interval 7407.6 to 12880.1
|
11445.8 EL.U/mL
Interval 8371.9 to 15648.3
|
9308.8 EL.U/mL
Interval 7285.1 to 11894.6
|
10283.6 EL.U/mL
Interval 6627.6 to 15956.4
|
7937 EL.U/mL
Interval 5903.9 to 10670.1
|
11617.9 EL.U/mL
Interval 8948.6 to 15083.3
|
7646.4 EL.U/mL
Interval 5326.5 to 10976.9
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, Day 1
|
5848.2 EL.U/mL
Interval 4577.0 to 7472.5
|
5975.5 EL.U/mL
Interval 4615.6 to 7736.1
|
6882.1 EL.U/mL
Interval 5488.8 to 8629.2
|
5968.7 EL.U/mL
Interval 4723.0 to 7542.9
|
6704 EL.U/mL
Interval 5329.0 to 8433.8
|
5513.6 EL.U/mL
Interval 4551.7 to 6678.7
|
6042.3 EL.U/mL
Interval 4790.1 to 7622.0
|
5917.2 EL.U/mL
Interval 4681.7 to 7478.9
|
6320.1 EL.U/mL
Interval 4858.6 to 8221.2
|
5512.2 EL.U/mL
Interval 4373.1 to 6948.0
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, Day 29
|
111973.1 EL.U/mL
Interval 90350.2 to 138770.8
|
28538 EL.U/mL
Interval 22181.5 to 36716.0
|
115020.5 EL.U/mL
Interval 93922.9 to 140857.1
|
59190.1 EL.U/mL
Interval 46420.7 to 75472.2
|
30980 EL.U/mL
Interval 25025.9 to 38350.8
|
64182.7 EL.U/mL
Interval 50875.4 to 80970.8
|
30976.4 EL.U/mL
Interval 20643.7 to 46481.0
|
12700 EL.U/mL
Interval 10182.5 to 15839.8
|
33198.1 EL.U/mL
Interval 25465.3 to 43279.1
|
10941.3 EL.U/mL
Interval 8962.2 to 13357.5
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, Day 85
|
42295.4 EL.U/mL
Interval 34505.4 to 51844.2
|
18172.7 EL.U/mL
Interval 13948.3 to 23676.6
|
60609.1 EL.U/mL
Interval 47899.9 to 76690.5
|
26581.4 EL.U/mL
Interval 19839.5 to 35614.4
|
16519.5 EL.U/mL
Interval 13127.6 to 20787.9
|
39576.4 EL.U/mL
Interval 31245.9 to 50128.0
|
23576.8 EL.U/mL
Interval 15654.3 to 35508.7
|
9640.8 EL.U/mL
Interval 7382.5 to 12590.1
|
29437.8 EL.U/mL
Interval 22555.8 to 38419.7
|
8939.2 EL.U/mL
Interval 7063.2 to 11313.4
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M14
|
21754.4 EL.U/mL
Interval 17375.9 to 27236.2
|
11417.4 EL.U/mL
Interval 8969.1 to 14534.0
|
30670.3 EL.U/mL
Interval 23748.7 to 39609.2
|
17100.4 EL.U/mL
Interval 12454.3 to 23479.8
|
10899.7 EL.U/mL
Interval 8122.1 to 14627.2
|
19573.6 EL.U/mL
Interval 14935.3 to 25652.3
|
15050.2 EL.U/mL
Interval 9969.1 to 22721.0
|
7717.7 EL.U/mL
Interval 5839.8 to 10199.6
|
21978.5 EL.U/mL
Interval 17171.0 to 28132.1
|
8582.5 EL.U/mL
Interval 6443.9 to 11430.8
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M20
|
24198.7 EL.U/mL
Interval 19291.6 to 30353.9
|
34266 EL.U/mL
Interval 26622.0 to 44104.8
|
36950 EL.U/mL
Interval 29306.1 to 46587.6
|
19456.7 EL.U/mL
Interval 14167.4 to 26720.7
|
32287.4 EL.U/mL
Interval 25257.3 to 41274.2
|
28818 EL.U/mL
Interval 22130.7 to 37525.9
|
14269 EL.U/mL
Interval 9295.0 to 21905.0
|
15780.8 EL.U/mL
Interval 11287.6 to 22062.7
|
25006.7 EL.U/mL
Interval 19478.3 to 32104.2
|
7961.8 EL.U/mL
Interval 5712.7 to 11096.2
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M26
|
20136.5 EL.U/mL
Interval 16257.6 to 24940.8
|
27000.7 EL.U/mL
Interval 21059.5 to 34617.9
|
29403.8 EL.U/mL
Interval 22530.7 to 38373.5
|
15358.6 EL.U/mL
Interval 11070.7 to 21307.3
|
27477.2 EL.U/mL
Interval 20295.7 to 37199.7
|
22917.6 EL.U/mL
Interval 17205.8 to 30525.6
|
14906.4 EL.U/mL
Interval 9433.3 to 23554.9
|
13186.7 EL.U/mL
Interval 9162.6 to 18978.2
|
23570.6 EL.U/mL
Interval 18496.4 to 30036.9
|
7708.3 EL.U/mL
Interval 5593.3 to 10623.1
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, Day 1
|
4936.1 EL.U/mL
Interval 3878.3 to 6282.3
|
4845.1 EL.U/mL
Interval 3641.3 to 6446.9
|
5936.9 EL.U/mL
Interval 4557.4 to 7734.1
|
5299.3 EL.U/mL
Interval 4197.0 to 6691.1
|
5368.1 EL.U/mL
Interval 4259.0 to 6766.0
|
4651.7 EL.U/mL
Interval 3734.8 to 5793.7
|
4991.2 EL.U/mL
Interval 4039.5 to 6167.0
|
5543.3 EL.U/mL
Interval 4394.6 to 6992.4
|
5399.2 EL.U/mL
Interval 4075.9 to 7152.3
|
5681.1 EL.U/mL
Interval 4327.4 to 7458.4
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, Day 29
|
26663.7 EL.U/mL
Interval 21555.9 to 32981.8
|
19762.5 EL.U/mL
Interval 15199.9 to 25694.6
|
30387.7 EL.U/mL
Interval 25266.3 to 36547.2
|
19951 EL.U/mL
Interval 16410.4 to 24255.6
|
21416.3 EL.U/mL
Interval 17539.0 to 26150.8
|
19348 EL.U/mL
Interval 16009.2 to 23383.0
|
13383.5 EL.U/mL
Interval 9734.9 to 18399.5
|
10899.9 EL.U/mL
Interval 8829.7 to 13455.5
|
14152.1 EL.U/mL
Interval 11530.1 to 17370.3
|
11675.5 EL.U/mL
Interval 9209.8 to 14801.4
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, Day 85
|
13071 EL.U/mL
Interval 10618.2 to 16090.3
|
13472.1 EL.U/mL
Interval 10474.3 to 17327.9
|
27305.6 EL.U/mL
Interval 22369.5 to 33330.8
|
10270.7 EL.U/mL
Interval 8541.1 to 12350.5
|
12017.1 EL.U/mL
Interval 9474.7 to 15241.8
|
17205.7 EL.U/mL
Interval 14796.1 to 20007.7
|
10062.6 EL.U/mL
Interval 7439.9 to 13610.1
|
8762.3 EL.U/mL
Interval 6910.2 to 11110.9
|
15219.4 EL.U/mL
Interval 12301.2 to 18829.9
|
9136.2 EL.U/mL
Interval 6966.1 to 11982.3
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M14
|
9039.6 EL.U/mL
Interval 7212.3 to 11329.9
|
8610.3 EL.U/mL
Interval 6938.0 to 10685.6
|
14078.6 EL.U/mL
Interval 11455.9 to 17301.7
|
8820.4 EL.U/mL
Interval 6959.4 to 11179.1
|
8370.2 EL.U/mL
Interval 6213.2 to 11276.0
|
10216.5 EL.U/mL
Interval 8035.8 to 12989.1
|
8526.2 EL.U/mL
Interval 6047.8 to 12020.2
|
6955.8 EL.U/mL
Interval 5553.1 to 8713.0
|
11876.7 EL.U/mL
Interval 9622.1 to 14659.6
|
8178.4 EL.U/mL
Interval 6007.8 to 11133.2
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M14+28 days
|
19763.3 EL.U/mL
Interval 15225.3 to 25653.9
|
26567.6 EL.U/mL
Interval 21331.9 to 33088.4
|
20291 EL.U/mL
Interval 17142.5 to 24017.8
|
15768 EL.U/mL
Interval 12672.2 to 19620.0
|
24020.6 EL.U/mL
Interval 19157.0 to 30118.9
|
15872.3 EL.U/mL
Interval 12888.2 to 19547.3
|
11742.6 EL.U/mL
Interval 8553.4 to 16120.9
|
12543.5 EL.U/mL
Interval 9593.4 to 16400.7
|
14564 EL.U/mL
Interval 12163.0 to 17439.0
|
10758.1 EL.U/mL
Interval 8190.4 to 14130.7
|
|
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M20
|
12192 EL.U/mL
Interval 9446.1 to 15736.1
|
14228.2 EL.U/mL
Interval 11276.5 to 17952.5
|
13068.8 EL.U/mL
Interval 10894.9 to 15676.5
|
10503.1 EL.U/mL
Interval 8169.3 to 13503.6
|
12541.2 EL.U/mL
Interval 9836.1 to 15990.2
|
10695.2 EL.U/mL
Interval 8464.7 to 13513.5
|
9695.4 EL.U/mL
Interval 6545.1 to 14362.2
|
8934.7 EL.U/mL
Interval 6832.5 to 11683.6
|
12302.2 EL.U/mL
Interval 9853.6 to 15359.2
|
7764.5 EL.U/mL
Interval 5518.3 to 10925.1
|
SECONDARY outcome
Timeframe: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H2 and anti-H18 immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=45 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, Day 29
|
43 Participants
|
40 Participants
|
41 Participants
|
40 Participants
|
42 Participants
|
42 Participants
|
37 Participants
|
41 Participants
|
39 Participants
|
40 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M8
|
39 Participants
|
34 Participants
|
30 Participants
|
27 Participants
|
36 Participants
|
33 Participants
|
30 Participants
|
34 Participants
|
33 Participants
|
34 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M14+28 days
|
28 Participants
|
31 Participants
|
23 Participants
|
25 Participants
|
29 Participants
|
29 Participants
|
22 Participants
|
26 Participants
|
27 Participants
|
29 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, Day 85
|
39 Participants
|
36 Participants
|
34 Participants
|
35 Participants
|
39 Participants
|
35 Participants
|
34 Participants
|
34 Participants
|
35 Participants
|
38 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, Day 1
|
45 Participants
|
46 Participants
|
47 Participants
|
47 Participants
|
48 Participants
|
47 Participants
|
47 Participants
|
46 Participants
|
44 Participants
|
45 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, Day 85
|
39 Participants
|
36 Participants
|
34 Participants
|
35 Participants
|
39 Participants
|
35 Participants
|
34 Participants
|
34 Participants
|
35 Participants
|
38 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M14
|
35 Participants
|
32 Participants
|
26 Participants
|
26 Participants
|
31 Participants
|
31 Participants
|
25 Participants
|
30 Participants
|
30 Participants
|
31 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M20
|
29 Participants
|
30 Participants
|
24 Participants
|
24 Participants
|
31 Participants
|
27 Participants
|
20 Participants
|
27 Participants
|
27 Participants
|
25 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H2, M26
|
29 Participants
|
29 Participants
|
22 Participants
|
21 Participants
|
25 Participants
|
25 Participants
|
20 Participants
|
25 Participants
|
25 Participants
|
23 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, Day 1
|
45 Participants
|
46 Participants
|
46 Participants
|
47 Participants
|
48 Participants
|
47 Participants
|
47 Participants
|
46 Participants
|
44 Participants
|
45 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, Day 29
|
43 Participants
|
40 Participants
|
41 Participants
|
40 Participants
|
42 Participants
|
42 Participants
|
37 Participants
|
41 Participants
|
39 Participants
|
40 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M8
|
39 Participants
|
34 Participants
|
30 Participants
|
27 Participants
|
36 Participants
|
33 Participants
|
30 Participants
|
34 Participants
|
33 Participants
|
34 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M14
|
35 Participants
|
32 Participants
|
26 Participants
|
26 Participants
|
31 Participants
|
31 Participants
|
25 Participants
|
30 Participants
|
30 Participants
|
31 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M14+28 days
|
28 Participants
|
31 Participants
|
23 Participants
|
25 Participants
|
29 Participants
|
29 Participants
|
22 Participants
|
26 Participants
|
27 Participants
|
29 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M20
|
29 Participants
|
30 Participants
|
24 Participants
|
24 Participants
|
31 Participants
|
27 Participants
|
20 Participants
|
27 Participants
|
27 Participants
|
25 Participants
|
|
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
Anti-H18, M26
|
29 Participants
|
29 Participants
|
22 Participants
|
21 Participants
|
25 Participants
|
25 Participants
|
20 Participants
|
25 Participants
|
25 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 4-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M8
|
51.3 Percentage of subjects
Interval 34.8 to 67.6
|
23.5 Percentage of subjects
Interval 10.7 to 41.2
|
73.3 Percentage of subjects
Interval 54.1 to 87.7
|
29.6 Percentage of subjects
Interval 13.8 to 50.2
|
8.3 Percentage of subjects
Interval 1.8 to 22.5
|
69.7 Percentage of subjects
Interval 51.3 to 84.4
|
26.7 Percentage of subjects
Interval 12.3 to 45.9
|
5.9 Percentage of subjects
Interval 0.7 to 19.7
|
33.3 Percentage of subjects
Interval 18.0 to 51.8
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M14
|
34.3 Percentage of subjects
Interval 19.1 to 52.2
|
15.6 Percentage of subjects
Interval 5.3 to 32.8
|
61.5 Percentage of subjects
Interval 40.6 to 79.8
|
30.8 Percentage of subjects
Interval 14.3 to 51.8
|
6.5 Percentage of subjects
Interval 0.8 to 21.4
|
58.1 Percentage of subjects
Interval 39.1 to 75.5
|
16 Percentage of subjects
Interval 4.5 to 36.1
|
3.3 Percentage of subjects
Interval 0.1 to 17.2
|
23.3 Percentage of subjects
Interval 9.9 to 42.3
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M14+28 days
|
57.1 Percentage of subjects
Interval 37.2 to 75.5
|
100 Percentage of subjects
Interval 88.8 to 100.0
|
100 Percentage of subjects
Interval 85.2 to 100.0
|
52 Percentage of subjects
Interval 31.3 to 72.2
|
82.8 Percentage of subjects
Interval 64.2 to 94.2
|
96.6 Percentage of subjects
Interval 82.2 to 99.9
|
36.4 Percentage of subjects
Interval 17.2 to 59.3
|
50 Percentage of subjects
Interval 29.9 to 70.1
|
63 Percentage of subjects
Interval 42.4 to 80.6
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M26
|
41.4 Percentage of subjects
Interval 23.5 to 61.1
|
62.1 Percentage of subjects
Interval 42.3 to 79.3
|
54.5 Percentage of subjects
Interval 32.2 to 75.6
|
38.1 Percentage of subjects
Interval 18.1 to 61.6
|
48 Percentage of subjects
Interval 27.8 to 68.7
|
56 Percentage of subjects
Interval 34.9 to 75.6
|
20 Percentage of subjects
Interval 5.7 to 43.7
|
16 Percentage of subjects
Interval 4.5 to 36.1
|
32 Percentage of subjects
Interval 14.9 to 53.5
|
4.3 Percentage of subjects
Interval 0.1 to 21.9
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, Day 29
|
55.8 Percentage of subjects
Interval 39.9 to 70.9
|
52.5 Percentage of subjects
Interval 36.1 to 68.5
|
50 Percentage of subjects
Interval 33.8 to 66.2
|
40 Percentage of subjects
Interval 24.9 to 56.7
|
45.2 Percentage of subjects
Interval 29.8 to 61.3
|
52.4 Percentage of subjects
Interval 36.4 to 68.0
|
21.6 Percentage of subjects
Interval 9.8 to 38.2
|
19.5 Percentage of subjects
Interval 8.8 to 34.9
|
20.5 Percentage of subjects
Interval 9.3 to 36.5
|
15 Percentage of subjects
Interval 5.7 to 29.8
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M26
|
24.1 Percentage of subjects
Interval 10.3 to 43.5
|
31 Percentage of subjects
Interval 15.3 to 50.8
|
28.6 Percentage of subjects
Interval 11.3 to 52.2
|
23.8 Percentage of subjects
Interval 8.2 to 47.2
|
20 Percentage of subjects
Interval 6.8 to 40.7
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
10 Percentage of subjects
Interval 1.2 to 31.7
|
8 Percentage of subjects
Interval 1.0 to 26.0
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
0 Percentage of subjects
Interval 0.0 to 14.8
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M8
|
12.8 Percentage of subjects
Interval 4.3 to 27.4
|
20.6 Percentage of subjects
Interval 8.7 to 37.9
|
44.8 Percentage of subjects
Interval 26.4 to 64.3
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
11.1 Percentage of subjects
Interval 3.1 to 26.1
|
39.4 Percentage of subjects
Interval 22.9 to 57.9
|
16.7 Percentage of subjects
Interval 5.6 to 34.7
|
11.8 Percentage of subjects
Interval 3.3 to 27.5
|
24.2 Percentage of subjects
Interval 11.1 to 42.3
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M14
|
8.6 Percentage of subjects
Interval 1.8 to 23.1
|
21.9 Percentage of subjects
Interval 9.3 to 40.0
|
36 Percentage of subjects
Interval 18.0 to 57.5
|
11.5 Percentage of subjects
Interval 2.4 to 30.2
|
6.5 Percentage of subjects
Interval 0.8 to 21.4
|
29 Percentage of subjects
Interval 14.2 to 48.0
|
8 Percentage of subjects
Interval 1.0 to 26.0
|
3.3 Percentage of subjects
Interval 0.1 to 17.2
|
13.3 Percentage of subjects
Interval 3.8 to 30.7
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M14+28 days
|
35.7 Percentage of subjects
Interval 18.6 to 55.9
|
71 Percentage of subjects
Interval 52.0 to 85.8
|
54.5 Percentage of subjects
Interval 32.2 to 75.6
|
36 Percentage of subjects
Interval 18.0 to 57.5
|
55.2 Percentage of subjects
Interval 35.7 to 73.6
|
55.2 Percentage of subjects
Interval 35.7 to 73.6
|
18.2 Percentage of subjects
Interval 5.2 to 40.3
|
15.4 Percentage of subjects
Interval 4.4 to 34.9
|
25.9 Percentage of subjects
Interval 11.1 to 46.3
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M20
|
20.7 Percentage of subjects
Interval 8.0 to 39.7
|
40 Percentage of subjects
Interval 22.7 to 59.4
|
30.4 Percentage of subjects
Interval 13.2 to 52.9
|
20.8 Percentage of subjects
Interval 7.1 to 42.2
|
19.4 Percentage of subjects
Interval 7.5 to 37.5
|
29.6 Percentage of subjects
Interval 13.8 to 50.2
|
5 Percentage of subjects
Interval 0.1 to 24.9
|
7.4 Percentage of subjects
Interval 0.9 to 24.3
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
4 Percentage of subjects
Interval 0.1 to 20.4
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, Day 85
|
66.7 Percentage of subjects
Interval 49.8 to 80.9
|
36.1 Percentage of subjects
Interval 20.8 to 53.8
|
79.4 Percentage of subjects
Interval 62.1 to 91.3
|
45.7 Percentage of subjects
Interval 28.8 to 63.4
|
17.9 Percentage of subjects
Interval 7.5 to 33.5
|
77.1 Percentage of subjects
Interval 59.9 to 89.6
|
35.3 Percentage of subjects
Interval 19.7 to 53.5
|
2.9 Percentage of subjects
Interval 0.1 to 15.3
|
42.9 Percentage of subjects
Interval 26.3 to 60.6
|
5.3 Percentage of subjects
Interval 0.6 to 17.7
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M20
|
41.4 Percentage of subjects
Interval 23.5 to 61.1
|
70 Percentage of subjects
Interval 50.6 to 85.3
|
75 Percentage of subjects
Interval 53.3 to 90.2
|
41.7 Percentage of subjects
Interval 22.1 to 63.4
|
54.8 Percentage of subjects
Interval 36.0 to 72.7
|
74.1 Percentage of subjects
Interval 53.7 to 88.9
|
20 Percentage of subjects
Interval 5.7 to 43.7
|
18.5 Percentage of subjects
Interval 6.3 to 38.1
|
37 Percentage of subjects
Interval 19.4 to 57.6
|
4 Percentage of subjects
Interval 0.1 to 20.4
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, Day 85
|
17.9 Percentage of subjects
Interval 7.5 to 33.5
|
33.3 Percentage of subjects
Interval 18.6 to 51.0
|
48.5 Percentage of subjects
Interval 30.8 to 66.5
|
14.3 Percentage of subjects
Interval 4.8 to 30.3
|
20.5 Percentage of subjects
Interval 9.3 to 36.5
|
48.6 Percentage of subjects
Interval 31.4 to 66.0
|
14.7 Percentage of subjects
Interval 5.0 to 31.1
|
5.9 Percentage of subjects
Interval 0.7 to 19.7
|
25.7 Percentage of subjects
Interval 12.5 to 43.3
|
5.3 Percentage of subjects
Interval 0.6 to 17.7
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, Day 29
|
95.3 Percentage of subjects
Interval 84.2 to 99.4
|
62.5 Percentage of subjects
Interval 45.8 to 77.3
|
92.7 Percentage of subjects
Interval 80.1 to 98.5
|
82.5 Percentage of subjects
Interval 67.2 to 92.7
|
57.1 Percentage of subjects
Interval 41.0 to 72.3
|
90.5 Percentage of subjects
Interval 77.4 to 97.3
|
62.2 Percentage of subjects
Interval 44.8 to 77.5
|
26.8 Percentage of subjects
Interval 14.2 to 42.9
|
48.7 Percentage of subjects
Interval 32.4 to 65.2
|
12.5 Percentage of subjects
Interval 4.2 to 26.8
|
SECONDARY outcome
Timeframe: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 10-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M14+28 days
|
17.9 Percentage of subjects
Interval 6.1 to 36.9
|
25.8 Percentage of subjects
Interval 11.9 to 44.6
|
18.2 Percentage of subjects
Interval 5.2 to 40.3
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
17.2 Percentage of subjects
Interval 5.8 to 35.8
|
3.4 Percentage of subjects
Interval 0.1 to 17.8
|
4.5 Percentage of subjects
Interval 0.1 to 22.8
|
7.7 Percentage of subjects
Interval 0.9 to 25.1
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
0 Percentage of subjects
Interval 0.0 to 11.9
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, Day 29
|
67.4 Percentage of subjects
Interval 51.5 to 80.9
|
15 Percentage of subjects
Interval 5.7 to 29.8
|
68.3 Percentage of subjects
Interval 51.9 to 81.9
|
42.5 Percentage of subjects
Interval 27.0 to 59.1
|
16.7 Percentage of subjects
Interval 7.0 to 31.4
|
61.9 Percentage of subjects
Interval 45.6 to 76.4
|
18.9 Percentage of subjects
Interval 8.0 to 35.2
|
2.4 Percentage of subjects
Interval 0.1 to 12.9
|
20.5 Percentage of subjects
Interval 9.3 to 36.5
|
2.5 Percentage of subjects
Interval 0.1 to 13.2
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M8
|
15.4 Percentage of subjects
Interval 5.9 to 30.5
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
26.7 Percentage of subjects
Interval 12.3 to 45.9
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
0 Percentage of subjects
Interval 0.0 to 9.7
|
12.1 Percentage of subjects
Interval 3.4 to 28.2
|
16.7 Percentage of subjects
Interval 5.6 to 34.7
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
15.2 Percentage of subjects
Interval 5.1 to 31.9
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M14+28 days
|
25 Percentage of subjects
Interval 10.7 to 44.9
|
71 Percentage of subjects
Interval 52.0 to 85.8
|
65.2 Percentage of subjects
Interval 42.7 to 83.6
|
24 Percentage of subjects
Interval 9.4 to 45.1
|
48.3 Percentage of subjects
Interval 29.4 to 67.5
|
65.5 Percentage of subjects
Interval 45.7 to 82.1
|
9.1 Percentage of subjects
Interval 1.1 to 29.2
|
15.4 Percentage of subjects
Interval 4.4 to 34.9
|
22.2 Percentage of subjects
Interval 8.6 to 42.3
|
3.4 Percentage of subjects
Interval 0.1 to 17.8
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M26
|
13.8 Percentage of subjects
Interval 3.9 to 31.7
|
13.8 Percentage of subjects
Interval 3.9 to 31.7
|
18.2 Percentage of subjects
Interval 5.2 to 40.3
|
9.5 Percentage of subjects
Interval 1.2 to 30.4
|
24 Percentage of subjects
Interval 9.4 to 45.1
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
10 Percentage of subjects
Interval 1.2 to 31.7
|
8 Percentage of subjects
Interval 1.0 to 26.0
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
0 Percentage of subjects
Interval 0.0 to 14.8
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M14
|
0 Percentage of subjects
Interval 0.0 to 10.0
|
0 Percentage of subjects
Interval 0.0 to 10.9
|
12 Percentage of subjects
Interval 2.5 to 31.2
|
3.8 Percentage of subjects
Interval 0.1 to 19.6
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
4 Percentage of subjects
Interval 0.1 to 20.4
|
0 Percentage of subjects
Interval 0.0 to 11.6
|
10 Percentage of subjects
Interval 2.1 to 26.5
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M20
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
13.3 Percentage of subjects
Interval 3.8 to 30.7
|
4.3 Percentage of subjects
Interval 0.1 to 21.9
|
4.2 Percentage of subjects
Interval 0.1 to 21.1
|
6.5 Percentage of subjects
Interval 0.8 to 21.4
|
0 Percentage of subjects
Interval 0.0 to 12.8
|
5 Percentage of subjects
Interval 0.1 to 24.9
|
3.7 Percentage of subjects
Interval 0.1 to 19.0
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
0 Percentage of subjects
Interval 0.0 to 13.7
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M26
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
10.3 Percentage of subjects
Interval 2.2 to 27.4
|
4.8 Percentage of subjects
Interval 0.1 to 23.8
|
4.8 Percentage of subjects
Interval 0.1 to 23.8
|
8 Percentage of subjects
Interval 1.0 to 26.0
|
0 Percentage of subjects
Interval 0.0 to 13.7
|
10 Percentage of subjects
Interval 1.2 to 31.7
|
0 Percentage of subjects
Interval 0.0 to 13.7
|
8 Percentage of subjects
Interval 1.0 to 26.0
|
0 Percentage of subjects
Interval 0.0 to 14.8
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, Day 29
|
23.3 Percentage of subjects
Interval 11.8 to 38.6
|
15 Percentage of subjects
Interval 5.7 to 29.8
|
25 Percentage of subjects
Interval 12.7 to 41.2
|
12.5 Percentage of subjects
Interval 4.2 to 26.8
|
16.7 Percentage of subjects
Interval 7.0 to 31.4
|
16.7 Percentage of subjects
Interval 7.0 to 31.4
|
8.1 Percentage of subjects
Interval 1.7 to 21.9
|
2.4 Percentage of subjects
Interval 0.1 to 12.9
|
7.7 Percentage of subjects
Interval 1.6 to 20.9
|
2.5 Percentage of subjects
Interval 0.1 to 13.2
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, Day 85
|
25.6 Percentage of subjects
Interval 13.0 to 42.1
|
5.6 Percentage of subjects
Interval 0.7 to 18.7
|
55.9 Percentage of subjects
Interval 37.9 to 72.8
|
22.9 Percentage of subjects
Interval 10.4 to 40.1
|
2.6 Percentage of subjects
Interval 0.1 to 13.5
|
48.6 Percentage of subjects
Interval 31.4 to 66.0
|
20.6 Percentage of subjects
Interval 8.7 to 37.9
|
2.9 Percentage of subjects
Interval 0.1 to 15.3
|
17.1 Percentage of subjects
Interval 6.6 to 33.6
|
5.3 Percentage of subjects
Interval 0.6 to 17.7
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M14
|
14.3 Percentage of subjects
Interval 4.8 to 30.3
|
0 Percentage of subjects
Interval 0.0 to 10.9
|
23.1 Percentage of subjects
Interval 9.0 to 43.6
|
11.5 Percentage of subjects
Interval 2.4 to 30.2
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
6.5 Percentage of subjects
Interval 0.8 to 21.4
|
8 Percentage of subjects
Interval 1.0 to 26.0
|
0 Percentage of subjects
Interval 0.0 to 11.6
|
10 Percentage of subjects
Interval 2.1 to 26.5
|
0 Percentage of subjects
Interval 0.0 to 11.2
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H2, M20
|
13.8 Percentage of subjects
Interval 3.9 to 31.7
|
23.3 Percentage of subjects
Interval 9.9 to 42.3
|
25 Percentage of subjects
Interval 9.8 to 46.7
|
20.8 Percentage of subjects
Interval 7.1 to 42.2
|
25.8 Percentage of subjects
Interval 11.9 to 44.6
|
22.2 Percentage of subjects
Interval 8.6 to 42.3
|
5 Percentage of subjects
Interval 0.1 to 24.9
|
7.4 Percentage of subjects
Interval 0.9 to 24.3
|
11.1 Percentage of subjects
Interval 2.4 to 29.2
|
0 Percentage of subjects
Interval 0.0 to 13.7
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, Day 85
|
7.7 Percentage of subjects
Interval 1.6 to 20.9
|
2.8 Percentage of subjects
Interval 0.1 to 14.5
|
24.2 Percentage of subjects
Interval 11.1 to 42.3
|
5.7 Percentage of subjects
Interval 0.7 to 19.2
|
2.6 Percentage of subjects
Interval 0.1 to 13.5
|
5.7 Percentage of subjects
Interval 0.7 to 19.2
|
2.9 Percentage of subjects
Interval 0.1 to 15.3
|
2.9 Percentage of subjects
Interval 0.1 to 15.3
|
11.4 Percentage of subjects
Interval 3.2 to 26.7
|
5.3 Percentage of subjects
Interval 0.6 to 17.7
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Anti-H18, M8
|
2.6 Percentage of subjects
Interval 0.1 to 13.5
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
3.7 Percentage of subjects
Interval 0.1 to 19.0
|
0 Percentage of subjects
Interval 0.0 to 9.7
|
3 Percentage of subjects
Interval 0.1 to 15.8
|
6.7 Percentage of subjects
Interval 0.8 to 22.1
|
2.9 Percentage of subjects
Interval 0.1 to 15.3
|
9.1 Percentage of subjects
Interval 1.9 to 24.3
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
SECONDARY outcome
Timeframe: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=41 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=40 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=42 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H2, Day 29
|
18.4 Ratio
Interval 13.6 to 24.9
|
5.3 Ratio
Interval 4.0 to 7.0
|
17.3 Ratio
Interval 12.9 to 23.1
|
9.9 Ratio
Interval 7.0 to 14.0
|
4.7 Ratio
Interval 3.7 to 6.0
|
12.3 Ratio
Interval 9.2 to 16.3
|
5.6 Ratio
Interval 3.8 to 8.1
|
2.3 Ratio
Interval 1.8 to 2.9
|
5 Ratio
Interval 3.5 to 7.0
|
1.9 Ratio
Interval 1.6 to 2.3
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H2, Day 85
|
7 Ratio
Interval 5.2 to 9.2
|
3.2 Ratio
Interval 2.5 to 4.2
|
9.5 Ratio
Interval 7.2 to 12.5
|
4.4 Ratio
Interval 3.0 to 6.5
|
2.4 Ratio
Interval 2.0 to 2.9
|
8.2 Ratio
Interval 6.3 to 10.7
|
4.1 Ratio
Interval 2.8 to 5.8
|
1.7 Ratio
Interval 1.4 to 2.0
|
4.2 Ratio
Interval 2.9 to 6.1
|
1.6 Ratio
Interval 1.3 to 1.9
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H2, M8
|
4.8 Ratio
Interval 3.7 to 6.2
|
2.4 Ratio
Interval 1.9 to 2.9
|
6.2 Ratio
Interval 4.6 to 8.4
|
3.1 Ratio
Interval 2.1 to 4.4
|
1.8 Ratio
Interval 1.5 to 2.1
|
5.2 Ratio
Interval 4.0 to 6.6
|
3.3 Ratio
Interval 2.2 to 4.9
|
1.5 Ratio
Interval 1.3 to 1.8
|
3.3 Ratio
Interval 2.3 to 4.7
|
1.5 Ratio
Interval 1.3 to 1.7
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H2, M14
|
3.6 Ratio
Interval 2.8 to 4.7
|
2.2 Ratio
Interval 1.8 to 2.6
|
5.6 Ratio
Interval 3.9 to 8.1
|
3.1 Ratio
Interval 2.1 to 4.5
|
1.6 Ratio
Interval 1.4 to 2.0
|
4.1 Ratio
Interval 3.3 to 5.3
|
2.5 Ratio
Interval 1.8 to 3.6
|
1.4 Ratio
Interval 1.2 to 1.7
|
2.8 Ratio
Interval 2.0 to 4.0
|
1.4 Ratio
Interval 1.2 to 1.6
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H2, M14+28 days
|
6.1 Ratio
Interval 4.3 to 8.7
|
17.2 Ratio
Interval 12.5 to 23.8
|
14.7 Ratio
Interval 10.4 to 20.8
|
5.1 Ratio
Interval 3.4 to 7.7
|
12.1 Ratio
Interval 8.0 to 18.3
|
12.6 Ratio
Interval 9.7 to 16.2
|
3.3 Ratio
Interval 2.3 to 4.8
|
5.6 Ratio
Interval 3.7 to 8.4
|
6.1 Ratio
Interval 4.2 to 8.9
|
1.9 Ratio
Interval 1.5 to 2.3
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H2, M20
|
3.9 Ratio
Interval 3.0 to 5.1
|
6.4 Ratio
Interval 4.8 to 8.7
|
6.5 Ratio
Interval 4.6 to 9.0
|
3.6 Ratio
Interval 2.4 to 5.3
|
4.8 Ratio
Interval 3.4 to 6.9
|
6.2 Ratio
Interval 4.8 to 8.0
|
2.5 Ratio
Interval 1.7 to 3.6
|
2.7 Ratio
Interval 1.9 to 3.9
|
3.7 Ratio
Interval 2.6 to 5.2
|
1.3 Ratio
Interval 1.1 to 1.6
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H18, Day 29
|
5.2 Ratio
Interval 3.9 to 6.9
|
4.6 Ratio
Interval 3.5 to 6.0
|
5.3 Ratio
Interval 3.8 to 7.3
|
3.7 Ratio
Interval 2.8 to 4.9
|
4.1 Ratio
Interval 3.2 to 5.3
|
4.3 Ratio
Interval 3.3 to 5.6
|
2.7 Ratio
Interval 2.0 to 3.7
|
2.1 Ratio
Interval 1.7 to 2.7
|
2.5 Ratio
Interval 1.9 to 3.3
|
2 Ratio
Interval 1.7 to 2.4
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H18, Day 85
|
2.6 Ratio
Interval 2.1 to 3.3
|
2.9 Ratio
Interval 2.2 to 3.7
|
4.9 Ratio
Interval 3.7 to 6.5
|
2 Ratio
Interval 1.5 to 2.7
|
2.2 Ratio
Interval 1.8 to 2.7
|
4.3 Ratio
Interval 3.4 to 5.3
|
2 Ratio
Interval 1.5 to 2.7
|
1.6 Ratio
Interval 1.4 to 2.0
|
2.6 Ratio
Interval 1.9 to 3.6
|
1.6 Ratio
Interval 1.3 to 1.9
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H18, M8
|
2.4 Ratio
Interval 1.9 to 2.9
|
2.4 Ratio
Interval 1.9 to 3.0
|
3.5 Ratio
Interval 2.6 to 4.6
|
1.8 Ratio
Interval 1.4 to 2.4
|
1.8 Ratio
Interval 1.5 to 2.2
|
3.2 Ratio
Interval 2.6 to 3.9
|
2 Ratio
Interval 1.5 to 2.7
|
1.6 Ratio
Interval 1.3 to 2.0
|
2.3 Ratio
Interval 1.7 to 3.2
|
1.5 Ratio
Interval 1.3 to 1.7
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H18, M14
|
1.9 Ratio
Interval 1.5 to 2.2
|
2.1 Ratio
Interval 1.7 to 2.6
|
3.1 Ratio
Interval 2.3 to 4.4
|
1.8 Ratio
Interval 1.3 to 2.4
|
1.6 Ratio
Interval 1.3 to 2.0
|
2.6 Ratio
Interval 2.1 to 3.3
|
1.7 Ratio
Interval 1.2 to 2.3
|
1.3 Ratio
Interval 1.1 to 1.5
|
1.9 Ratio
Interval 1.4 to 2.5
|
1.3 Ratio
Interval 1.1 to 1.5
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H18, M20
|
2.5 Ratio
Interval 1.9 to 3.1
|
3.5 Ratio
Interval 2.6 to 4.8
|
2.7 Ratio
Interval 2.0 to 3.8
|
2.2 Ratio
Interval 1.6 to 3.1
|
2.4 Ratio
Interval 1.9 to 3.1
|
2.8 Ratio
Interval 2.3 to 3.5
|
2 Ratio
Interval 1.4 to 2.8
|
1.6 Ratio
Interval 1.3 to 2.0
|
2.1 Ratio
Interval 1.6 to 2.9
|
1.3 Ratio
Interval 1.1 to 1.6
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H18, M14+28 days
|
4.1 Ratio
Interval 2.9 to 5.7
|
6.4 Ratio
Interval 4.6 to 9.0
|
4.6 Ratio
Interval 3.1 to 6.6
|
3.3 Ratio
Interval 2.3 to 4.7
|
4.4 Ratio
Interval 3.3 to 5.9
|
4.3 Ratio
Interval 3.4 to 5.3
|
2.4 Ratio
Interval 1.8 to 3.3
|
2.4 Ratio
Interval 1.8 to 3.2
|
2.6 Ratio
Interval 1.8 to 3.6
|
1.7 Ratio
Interval 1.3 to 2.1
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H18, M26
|
2.4 Ratio
Interval 1.8 to 3.0
|
2.9 Ratio
Interval 2.1 to 3.9
|
2.4 Ratio
Interval 1.7 to 3.4
|
2.1 Ratio
Interval 1.5 to 3.1
|
2.2 Ratio
Interval 1.6 to 3.0
|
2.5 Ratio
Interval 2.0 to 3.1
|
2.1 Ratio
Interval 1.4 to 3.2
|
1.4 Ratio
Interval 1.1 to 1.8
|
1.9 Ratio
Interval 1.3 to 2.8
|
1.4 Ratio
Interval 1.2 to 1.6
|
|
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
Anti-H2, M26
|
3.5 Ratio
Interval 2.7 to 4.6
|
5 Ratio
Interval 3.7 to 6.7
|
5 Ratio
Interval 3.5 to 7.1
|
3 Ratio
Interval 2.0 to 4.7
|
4.2 Ratio
Interval 2.8 to 6.1
|
4.9 Ratio
Interval 3.7 to 6.5
|
2.6 Ratio
Interval 1.7 to 3.9
|
2.3 Ratio
Interval 1.6 to 3.4
|
3.2 Ratio
Interval 2.2 to 4.6
|
1.4 Ratio
Interval 1.2 to 1.6
|
SECONDARY outcome
Timeframe: At Days 1, 29 and 85Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=45 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay
Day 1
|
58.8 Titer
Interval 45.6 to 75.7
|
61 Titer
Interval 47.8 to 77.8
|
62.9 Titer
Interval 50.8 to 77.8
|
51.7 Titer
Interval 39.5 to 67.6
|
53.7 Titer
Interval 42.6 to 67.7
|
56.2 Titer
Interval 44.5 to 70.8
|
56.2 Titer
Interval 45.6 to 69.1
|
70.9 Titer
Interval 57.3 to 87.8
|
56.6 Titer
Interval 45.2 to 70.8
|
60.6 Titer
Interval 48.9 to 75.2
|
|
Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay
Day 29
|
84 Titer
Interval 68.8 to 102.5
|
93.5 Titer
Interval 76.7 to 113.9
|
87.2 Titer
Interval 77.0 to 98.8
|
84.3 Titer
Interval 74.2 to 95.7
|
93.1 Titer
Interval 82.2 to 105.5
|
80 Titer
Interval 67.8 to 94.4
|
71.5 Titer
Interval 59.4 to 86.0
|
78.7 Titer
Interval 64.9 to 95.4
|
69.4 Titer
Interval 54.1 to 88.9
|
103.7 Titer
Interval 88.0 to 122.3
|
|
Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay
Day 85
|
65.8 Titer
Interval 49.6 to 87.2
|
89.8 Titer
Interval 73.7 to 109.5
|
96.1 Titer
Interval 83.8 to 110.2
|
56 Titer
Interval 45.3 to 69.2
|
81.5 Titer
Interval 68.1 to 97.5
|
86.6 Titer
Interval 73.7 to 101.7
|
63.9 Titer
Interval 51.7 to 79.1
|
68 Titer
Interval 52.8 to 87.5
|
84.9 Titer
Interval 72.6 to 99.3
|
99.6 Titer
Interval 78.5 to 126.3
|
SECONDARY outcome
Timeframe: At Days 1, 29 and 85Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Anti-H1N1 swine influenza and anti-IIV4-H1N1 immune response measured by MN assay. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: cut-off = 20 1/DIL.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=45 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=46 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=47 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=46 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=44 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=45 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay
Day 1
|
40 Participants
|
41 Participants
|
43 Participants
|
38 Participants
|
42 Participants
|
42 Participants
|
44 Participants
|
43 Participants
|
42 Participants
|
43 Participants
|
|
Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay
Day 29
|
42 Participants
|
39 Participants
|
40 Participants
|
40 Participants
|
41 Participants
|
42 Participants
|
37 Participants
|
40 Participants
|
36 Participants
|
40 Participants
|
|
Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay
Day 85
|
36 Participants
|
35 Participants
|
34 Participants
|
34 Participants
|
38 Participants
|
35 Participants
|
34 Participants
|
32 Participants
|
35 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: At Day 29 and Day 85, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 4-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Day 29
|
9.3 Percentage of subjects
Interval 2.6 to 22.1
|
22.5 Percentage of subjects
Interval 10.8 to 38.5
|
7.7 Percentage of subjects
Interval 1.6 to 20.9
|
23.1 Percentage of subjects
Interval 11.1 to 39.3
|
24.4 Percentage of subjects
Interval 12.4 to 40.3
|
9.5 Percentage of subjects
Interval 2.7 to 22.6
|
10.8 Percentage of subjects
Interval 3.0 to 25.4
|
2.4 Percentage of subjects
Interval 0.1 to 12.9
|
7.7 Percentage of subjects
Interval 1.6 to 20.9
|
15 Percentage of subjects
Interval 5.7 to 29.8
|
|
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Day 85
|
5.1 Percentage of subjects
Interval 0.6 to 17.3
|
16.7 Percentage of subjects
Interval 6.4 to 32.8
|
18.2 Percentage of subjects
Interval 7.0 to 35.5
|
5.9 Percentage of subjects
Interval 0.7 to 19.7
|
21.1 Percentage of subjects
Interval 9.6 to 37.3
|
14.3 Percentage of subjects
Interval 4.8 to 30.3
|
5.9 Percentage of subjects
Interval 0.7 to 19.7
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
8.6 Percentage of subjects
Interval 1.8 to 23.1
|
15.8 Percentage of subjects
Interval 6.0 to 31.3
|
SECONDARY outcome
Timeframe: At Day 29 and Day 85, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
Percentage of subjects with a ≥ 10-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Day 29
|
2.3 Percentage of subjects
Interval 0.1 to 12.3
|
2.5 Percentage of subjects
Interval 0.1 to 13.2
|
0 Percentage of subjects
Interval 0.0 to 9.0
|
0 Percentage of subjects
Interval 0.0 to 9.0
|
0 Percentage of subjects
Interval 0.0 to 8.6
|
0 Percentage of subjects
Interval 0.0 to 8.4
|
0 Percentage of subjects
Interval 0.0 to 9.5
|
0 Percentage of subjects
Interval 0.0 to 8.6
|
0 Percentage of subjects
Interval 0.0 to 9.0
|
0 Percentage of subjects
Interval 0.0 to 8.8
|
|
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Day 85
|
0 Percentage of subjects
Interval 0.0 to 9.0
|
2.8 Percentage of subjects
Interval 0.1 to 14.5
|
3 Percentage of subjects
Interval 0.1 to 15.8
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
0 Percentage of subjects
Interval 0.0 to 9.3
|
2.9 Percentage of subjects
Interval 0.1 to 14.9
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
0 Percentage of subjects
Interval 0.0 to 10.3
|
0 Percentage of subjects
Interval 0.0 to 10.0
|
0 Percentage of subjects
Interval 0.0 to 9.3
|
SECONDARY outcome
Timeframe: At Day 29 and at Day 85, compared to Day 1Population: Analysis of immunogenicity was performed on the PPS which included all eligible subjects according to protocol and for whom immunogenicity results were available.
MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1.
Outcome measures
| Measure |
D-SUIV Adjuvanted Group 1
n=43 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=40 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=42 Participants
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=37 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=41 Participants
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=39 Participants
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=40 Participants
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay
Day 85
|
1.1 Ratio
Interval 0.9 to 1.3
|
1.5 Ratio
Interval 1.1 to 2.0
|
1.6 Ratio
Interval 1.2 to 2.1
|
1 Ratio
Interval 0.9 to 1.3
|
1.5 Ratio
Interval 1.2 to 1.9
|
1.5 Ratio
Interval 1.2 to 1.9
|
1.1 Ratio
Interval 0.9 to 1.3
|
0.9 Ratio
Interval 0.8 to 1.1
|
1.3 Ratio
Interval 1.1 to 1.6
|
1.5 Ratio
Interval 1.3 to 1.9
|
|
MGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay
Day 29
|
1.4 Ratio
Interval 1.1 to 1.7
|
1.7 Ratio
Interval 1.3 to 2.1
|
1.4 Ratio
Interval 1.2 to 1.6
|
1.7 Ratio
Interval 1.3 to 2.2
|
1.7 Ratio
Interval 1.4 to 2.2
|
1.4 Ratio
Interval 1.2 to 1.7
|
1.3 Ratio
Interval 1.0 to 1.5
|
1.1 Ratio
Interval 0.9 to 1.3
|
1.2 Ratio
Interval 1.0 to 1.5
|
1.7 Ratio
Interval 1.4 to 2.0
|
Adverse Events
D-SUIV Adjuvanted Group 1
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
D-SUIV Adjuvanted Group 2
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
D-SUIV Adjuvanted Group 3
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
D-SUIV Adjuvanted Group 4
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
D-SUIV Adjuvanted Group 5
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
D-SUIV Adjuvanted Group 6
Serious events: 2 serious events
Other events: 44 other events
Deaths: 1 deaths
D-SUIV Unadjuvanted Group 1
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
D-SUIV Unadjuvanted Group 2
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
D-SUIV Unadjuvanted Group 3
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
IIV4 Group
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
D-SUIV Adjuvanted Group 1
n=45 participants at risk
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 participants at risk
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 participants at risk
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 participants at risk
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 participants at risk
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 participants at risk
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 participants at risk
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=48 participants at risk
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 participants at risk
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=47 participants at risk
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Immune system disorders
Drug hypersensitivity
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Influenza
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Viral infection
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Wound infection
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage II
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
Other adverse events
| Measure |
D-SUIV Adjuvanted Group 1
n=45 participants at risk
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 2
n=46 participants at risk
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 3
n=47 participants at risk
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 4
n=47 participants at risk
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 5
n=48 participants at risk
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Adjuvanted Group 6
n=47 participants at risk
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 1
n=47 participants at risk
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 2
n=48 participants at risk
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
D-SUIV Unadjuvanted Group 3
n=46 participants at risk
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
IIV4 Group
n=47 participants at risk
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Nervous system disorders
Headache
|
55.6%
25/45 • Number of events 37 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
63.0%
29/46 • Number of events 50 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
63.8%
30/47 • Number of events 50 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
66.0%
31/47 • Number of events 49 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
52.1%
25/48 • Number of events 42 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
72.3%
34/47 • Number of events 55 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
42.6%
20/47 • Number of events 26 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
52.1%
25/48 • Number of events 43 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
43.5%
20/46 • Number of events 31 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
48.9%
23/47 • Number of events 28 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Nervous system disorders
Migraine
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Nervous system disorders
Parosmia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Psychiatric disorders
Abnormal dreams
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Psychiatric disorders
Depression
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.4%
3/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.3%
4/48 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/46 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site pain
|
82.2%
37/45 • Number of events 66 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
91.3%
42/46 • Number of events 75 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
87.2%
41/47 • Number of events 92 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
91.5%
43/47 • Number of events 69 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
87.5%
42/48 • Number of events 76 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
93.6%
44/47 • Number of events 99 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
38.3%
18/47 • Number of events 24 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
45.8%
22/48 • Number of events 28 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
50.0%
23/46 • Number of events 40 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
83.0%
39/47 • Number of events 66 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
2.2%
1/45 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.4%
2/45 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/46 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.4%
3/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
3/45 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
13.0%
6/46 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.6%
5/47 • Number of events 7 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.4%
5/48 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.6%
5/47 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.3%
4/48 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
13.0%
6/46 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.2%
3/48 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Eye disorders
Blepharospasm
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Eye disorders
Dry eye
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Eye disorders
Eye pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Eye disorders
Myopia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Eye disorders
Photophobia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Eye disorders
Vision blurred
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/46 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
22.2%
10/45 • Number of events 12 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
32.6%
15/46 • Number of events 19 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
29.8%
14/47 • Number of events 22 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
23.4%
11/47 • Number of events 14 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
25.0%
12/48 • Number of events 17 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
31.9%
15/47 • Number of events 19 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
17.0%
8/47 • Number of events 8 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
20.8%
10/48 • Number of events 14 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
26.1%
12/46 • Number of events 16 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
19.1%
9/47 • Number of events 10 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Chest discomfort
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Chest pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Chills
|
20.0%
9/45 • Number of events 13 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
34.8%
16/46 • Number of events 20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
31.9%
15/47 • Number of events 20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
27.7%
13/47 • Number of events 16 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
41.7%
20/48 • Number of events 25 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
36.2%
17/47 • Number of events 21 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.4%
3/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.3%
4/48 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.9%
5/46 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.4%
3/47 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Cyst
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Energy increased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Fatigue
|
55.6%
25/45 • Number of events 39 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
60.9%
28/46 • Number of events 44 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
59.6%
28/47 • Number of events 50 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
53.2%
25/47 • Number of events 40 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
52.1%
25/48 • Number of events 48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
55.3%
26/47 • Number of events 35 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
38.3%
18/47 • Number of events 24 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
50.0%
24/48 • Number of events 30 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
39.1%
18/46 • Number of events 28 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
31.9%
15/47 • Number of events 21 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Influenza like illness
|
8.9%
4/45 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.5%
3/46 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.5%
4/47 • Number of events 7 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.4%
3/47 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.3%
4/48 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site bruising
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site erythema
|
4.4%
2/45 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.7%
4/46 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.4%
3/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.5%
4/47 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site haematoma
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site lymphadenopathy
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site mass
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site pruritus
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site reaction
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.4%
3/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site swelling
|
11.1%
5/45 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.7%
4/46 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.6%
5/47 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.6%
5/47 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.3%
4/48 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Injection site warmth
|
2.2%
1/45 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Malaise
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Peripheral swelling
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Pyrexia
|
15.6%
7/45 • Number of events 7 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
23.9%
11/46 • Number of events 17 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
17.0%
8/47 • Number of events 8 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
19.1%
9/47 • Number of events 10 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
12.5%
6/48 • Number of events 9 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
19.1%
9/47 • Number of events 11 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.6%
5/47 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.3%
4/48 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
13.0%
6/46 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
12.8%
6/47 • Number of events 7 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Swelling
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Thirst
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
General disorders
Vaccination site pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Ear infection
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Eye infection
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Gastroenteritis viral
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
3/45 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.7%
4/46 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.5%
3/46 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Otitis media
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Pharyngitis
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Sinusitis
|
8.9%
4/45 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/46 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
2/45 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
15.2%
7/46 • Number of events 7 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.6%
5/47 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.5%
4/47 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.2%
3/48 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.5%
4/47 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.6%
5/47 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
18.8%
9/48 • Number of events 9 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
15.2%
7/46 • Number of events 7 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
8.5%
4/47 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Viral infection
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/46 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/46 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Body temperature increased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Haemoglobin decreased
|
6.7%
3/45 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Lymphocyte percentage decreased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Lymphocyte percentage increased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Monocyte count increased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Neutrophil count decreased
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.4%
3/47 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
6.2%
3/48 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Neutrophil count increased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
Neutrophil percentage decreased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Investigations
White blood cell count increased
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.3%
24/45 • Number of events 37 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
50.0%
23/46 • Number of events 36 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
63.8%
30/47 • Number of events 47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
57.4%
27/47 • Number of events 33 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
54.2%
26/48 • Number of events 36 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
59.6%
28/47 • Number of events 44 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
21.3%
10/47 • Number of events 12 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
29.2%
14/48 • Number of events 15 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
32.6%
15/46 • Number of events 19 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
25.5%
12/47 • Number of events 17 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
12/45 • Number of events 13 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
28.3%
13/46 • Number of events 19 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
27.7%
13/47 • Number of events 17 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
12.8%
6/47 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
27.1%
13/48 • Number of events 17 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
27.7%
13/47 • Number of events 18 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
14.9%
7/47 • Number of events 8 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
12.5%
6/48 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.9%
5/46 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
10.6%
5/47 • Number of events 8 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.2%
2/48 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.2%
1/45 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Vascular disorders
Flushing
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Vascular disorders
Hypertension
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/48 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/45 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/48 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/46 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
0.00%
0/47 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER