Trial Outcomes & Findings for Safety and Immunogenicity of a Chlamydia Vaccine CTH522 (NCT NCT03926728)
NCT ID: NCT03926728
Last Updated: 2024-08-22
Results Overview
Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
Visit 2 (Day 0) plus 14 Days
Results posted on
2024-08-22
Participant Flow
Participant milestones
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01+ TO CTH522 + TO Placebo
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
9
|
3
|
9
|
3
|
9
|
3
|
9
|
3
|
9
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
8
|
2
|
9
|
3
|
8
|
2
|
9
|
3
|
8
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01+ TO CTH522 + TO Placebo
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of a Chlamydia Vaccine CTH522
Baseline characteristics by cohort
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
65 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Age, Continuous
|
22.0 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
21.7 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
28.4 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
32.3 years
STANDARD_DEVIATION 6.1 • n=21 Participants
|
22.4 years
STANDARD_DEVIATION 2.4 • n=10 Participants
|
25.7 years
STANDARD_DEVIATION 9 • n=115 Participants
|
26.8 years
STANDARD_DEVIATION 5.6 • n=6 Participants
|
31.7 years
STANDARD_DEVIATION 8.5 • n=6 Participants
|
30.1 years
STANDARD_DEVIATION 9.9 • n=64 Participants
|
24.7 years
STANDARD_DEVIATION 5.5 • n=17 Participants
|
25.0 years
STANDARD_DEVIATION 5.3 • n=21 Participants
|
26.8 years
STANDARD_DEVIATION 6.8 • n=22 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
34 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
31 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=10 Participants
|
3 participants
n=115 Participants
|
6 participants
n=6 Participants
|
1 participants
n=6 Participants
|
7 participants
n=64 Participants
|
3 participants
n=17 Participants
|
3 participants
n=21 Participants
|
46 participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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
|
3 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=6 Participants
|
1 participants
n=6 Participants
|
1 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
8 participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
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
|
1 participants
n=6 Participants
|
0 participants
n=6 Participants
|
1 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
3 participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=6 Participants
|
1 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
8 participants
n=22 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
3 participants
n=21 Participants
|
9 participants
n=10 Participants
|
3 participants
n=115 Participants
|
9 participants
n=6 Participants
|
3 participants
n=6 Participants
|
9 participants
n=64 Participants
|
3 participants
n=17 Participants
|
3 participants
n=21 Participants
|
65 participants
n=22 Participants
|
|
BMI
|
20.70 kg/m2
STANDARD_DEVIATION 3.96 • n=5 Participants
|
24.78 kg/m2
STANDARD_DEVIATION 3.02 • n=7 Participants
|
23.73 kg/m2
STANDARD_DEVIATION 2.25 • n=5 Participants
|
22.62 kg/m2
STANDARD_DEVIATION 3.58 • n=4 Participants
|
26.23 kg/m2
STANDARD_DEVIATION 2.55 • n=21 Participants
|
23.63 kg/m2
STANDARD_DEVIATION 2.41 • n=10 Participants
|
24.70 kg/m2
STANDARD_DEVIATION 1.55 • n=115 Participants
|
23.13 kg/m2
STANDARD_DEVIATION 1.67 • n=6 Participants
|
21.70 kg/m2
STANDARD_DEVIATION 0.92 • n=6 Participants
|
24.11 kg/m2
STANDARD_DEVIATION 3.55 • n=64 Participants
|
24.37 kg/m2
STANDARD_DEVIATION 3.20 • n=17 Participants
|
22.77 kg/m2
STANDARD_DEVIATION 0.55 • n=21 Participants
|
23.64 kg/m2
STANDARD_DEVIATION 2.78 • n=22 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Day 0) plus 14 DaysLocal injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Local Injection Site Reactions
Injection site pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Local Injection Site Reactions
Injection site pain
|
2 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
|
Solicited Local Injection Site Reactions
Injection site warmth
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Solicited Local Injection Site Reactions
Injection site swelling
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Local Injection Site Reactions
Injection site erythema
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (Day 28) plus 14 DaysPopulation: Percentages calculated from number of participants vaccinated on Day 28.
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Local Injection Site Reactions
Injection site pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Local Injection Site Reactions
Injection site swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Solicited Local Injection Site Reactions
Injection site pain
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Solicited Local Injection Site Reactions
Injection site warmth
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Solicited Local Injection Site Reactions
Injection site erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Visit 7 (Day 112) plus 14 DaysPopulation: Percentages calculated from number of participants vaccinated on Day 112
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=8 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=8 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Local Injection Site Reactions
Injection site pain
|
1 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
|
Solicited Local Injection Site Reactions
Injection site warmth
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Solicited Local Injection Site Reactions
Injection site swelling
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Local Injection Site Reactions
Injection site pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Local Injection Site Reactions
Injection site erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (Day 28) plus 14 DaysPopulation: Percentages calculated from number of participants vaccinated on Day 28
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Local Ocular Reactions
Ocular discomfort
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Solicited Local Ocular Reactions
Ocular hyperaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Local Ocular Reactions
Lacrimation increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Solicited Local Ocular Reactions
Swelling of eyelid
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Visit 7 (Day 112) plus 14 DaysPopulation: Percentages calculated from number of participants vaccinated on Day 112
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=8 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=8 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Local Ocular Reactions
Ocular hyperaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Solicited Local Ocular Reactions
Ocular discomfort
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Local Ocular Reactions
Lacrimation increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Visit 9 (Day 140) plus 14 DaysPopulation: Percentages calculated from number of participants vaccinated on Day 140
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=7 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=8 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=8 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Local Ocular Reactions
Ocular discomfort
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Solicited Local Ocular Reactions
Lacrimation increased
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Solicited Local Ocular Reactions
Ocular hyperaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Solicited Local Ocular Reactions
Swelling of eyelid
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Day 0) plus 14 DaysPopulation: Percentages calculated from number of participants vaccinated on Day 0
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Systemic Reactions
Myalgia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Systemic Reactions
Chills
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Systemic Reactions
Pyrexia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Systemic Reactions
Rash
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (Day 28) plus 14 DaysPopulation: Percentages calculated from number of participants vaccinated on Day 28
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Systemic Reactions
Pyrexia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Systemic Reactions
Myalgia
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Systemic Reactions
Chills
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Systemic Reactions
Rash
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Visit 7 (Day 112) plus 14 DaysPopulation: Percentages calculated from number of participants vaccinated on Day 112
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=8 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=8 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Solicited Systemic Reactions
Myalgia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Systemic Reactions
chills
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14, 28, 42, 56, 112, 126, 140, 154, 238Population: Frequency of 4-fold increase seroconversion for anti-CTH522 IgG - full analysis set
Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity (4-fold Increase From Baseline)
Day 14
|
0 Participants
|
6 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (4-fold Increase From Baseline)
Day 28
|
0 Participants
|
8 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (4-fold Increase From Baseline)
Day 42
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (4-fold Increase From Baseline)
Day 56
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (4-fold Increase From Baseline)
Day 112
|
1 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (4-fold Increase From Baseline)
Day 126
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (4-fold Increase From Baseline)
Day 140
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (4-fold Increase From Baseline)
Day 154
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (4-fold Increase From Baseline)
Day 238
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14, 28, 42, 56, 112, 126, 140, 154, 238Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
Outcome measures
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 Participants
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 Participants
Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity (10-fold Increase From Baseline)
Day 56
|
1 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (10-fold Increase From Baseline)
Day 112
|
1 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (10-fold Increase From Baseline)
Day 126
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (10-fold Increase From Baseline)
Day 140
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (10-fold Increase From Baseline)
Day 154
|
2 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (10-fold Increase From Baseline)
Day 238
|
1 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (10-fold Increase From Baseline)
Day 14
|
0 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (10-fold Increase From Baseline)
Day 28
|
0 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity (10-fold Increase From Baseline)
Day 42
|
1 Participants
|
8 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort F1 IM Placebo + TO Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort F2 IM Placebo + ID Placebo + TO Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo
n=2 participants at risk
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522
n=9 participants at risk
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo
n=3 participants at risk
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522
n=9 participants at risk
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.
|
Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo
n=3 participants at risk
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.
|
Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522
n=9 participants at risk
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.
|
Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo
n=3 participants at risk
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522
n=9 participants at risk
Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo
n=3 participants at risk
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522
n=9 participants at risk
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
|
Cohort F1 IM Placebo + TO Placebo
n=3 participants at risk
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.
|
Cohort F2 IM Placebo + ID Placebo + TO Placebo
n=3 participants at risk
Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye pruritus
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 5 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 6 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 5 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 7 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Mouth ulceration
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Chills
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 5 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site rash
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Blepharitis
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Eye discharge
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Eye irritation
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Eye disorders
Eye pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Feeling abnormal
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Feeling hot
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site bruising
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site erythema
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
3/3 • Number of events 7 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
88.9%
8/9 • Number of events 11 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 6 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site movement impairment
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site pain
|
100.0%
2/2 • Number of events 9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
9/9 • Number of events 37 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
3/3 • Number of events 13 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
9/9 • Number of events 48 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
3/3 • Number of events 11 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
9/9 • Number of events 48 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
3/3 • Number of events 10 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
9/9 • Number of events 42 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
3/3 • Number of events 16 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
100.0%
9/9 • Number of events 45 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site pruritus
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 5 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
55.6%
5/9 • Number of events 6 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site swelling
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Injection site warmth
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 6 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 7 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
6/9 • Number of events 11 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 6 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
55.6%
5/9 • Number of events 6 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Malaise
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Corona virus infection
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Investigations
Body temperature increased
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 5 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Pubic pain
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
6/9 • Number of events 9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 5 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 6 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Migraine
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
66.7%
2/3 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
44.4%
4/9 • Number of events 4 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 5 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
3/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
33.3%
1/3 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
50.0%
1/2 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/9 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
0.00%
0/3 • Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place