Trial Outcomes & Findings for A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults. (NCT NCT02017899)
NCT ID: NCT02017899
Last Updated: 2019-01-23
Results Overview
Any erythema/induration refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration \>100 mm in diameter. Grade 3 (severe) for injection site pain refers to: prevents daily activity
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
During a 7-day (Days 1-7) post vaccination period following any injection
Results posted on
2019-01-23
Participant Flow
Participant milestones
| Measure |
S. Sonnei 1790GAHB - 1 mcg
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 5 mcg
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
8
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
9
|
8
|
7
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
S. Sonnei 1790GAHB - 1 mcg
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 5 mcg
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
Baseline characteristics by cohort
| Measure |
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=8 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=9 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
Total
n=50 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
50 Participants
n=115 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
|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 7 • n=7 Participants
|
26.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
26.9 years
STANDARD_DEVIATION 4.2 • n=21 Participants
|
33.1 years
STANDARD_DEVIATION 8.2 • n=10 Participants
|
30.2 years
STANDARD_DEVIATION 6.9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
9 participants
n=21 Participants
|
8 participants
n=10 Participants
|
50 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: During a 7-day (Days 1-7) post vaccination period following any injectionPopulation: Analysis was done on as treated safety population
Any erythema/induration refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration \>100 mm in diameter. Grade 3 (severe) for injection site pain refers to: prevents daily activity
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=8 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=9 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local Reaction After Any Vaccination
Any Pain
|
9 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Solicited Local Reaction After Any Vaccination
Grade 3 Pain
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Reaction After Any Vaccination
Any Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Reaction After Any Vaccination
Grade 3 Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Reaction After Any Vaccination
Any Induration
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Reaction After Any Vaccination
Grade 3 Induration
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 7-day (Days 1 to 7) post vaccination period following any injectionPopulation: Analysis was done on as treated population
Any= Incidence of any symptom regardless of intensity grade. Grade 3 = symptom that prevented daily activities
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=8 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=9 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Any Headache
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Grade 3 Headache
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Any Arthralgia
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Grade 3 Arthralgia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Any Chills
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Grade 3 Chills
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Any Fatigue
|
3 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Any Malaise
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Grade 3 Malaise
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Any Myalgia
|
1 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Fever (≥38.0°C)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Fever (≥40.0°C)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 8Day 8: VISIT 2 (D7 post 1st vac)
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=8 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=9 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Neutrophils Results Below and Above the Normal Ranges
Neutrophils Results Below Normal Ranges
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Neutrophils Results Below and Above the Normal Ranges
Neutrophils Results Above Normal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 36Population: Some Arms have zero subjects attending visit 3.1, as complete blood counts testing 7 days after 2nd and 3rd vaccination was introduced following a protocol amendment while the study was ongoing.
Day 36: VISIT 3.1 (D7 post 2nd vac.)
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=5 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=8 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=3 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Below Normal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Above Normal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 57Day 57: VISIT 4 (3rd vac.)
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=7 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=7 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Below Normal Ranges
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Above Normal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 64Population: Some arms have zero subjects attending visit 3.1, as complete blood counts testing 7 days after 2nd and 3rd vaccination was introduced following a protocol amendment while the study was ongoing.
Day 64: VISIT 4.1 (D7 post 3rd vac.)
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=6 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=2 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=7 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=4 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Below Normal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Above Normal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 85Day 85: VISIT 5 (1 month post 3rd vac.)
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=6 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=8 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Below Normal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Above Normal Ranges
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 225Day 225: VISIT 6 (6 months post 3rd vac.)
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=7 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=8 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Below Normal Ranges
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Neutrophils Results Below and Above the Normal
Neutrophils Results Above Normal Ranges
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline, at 28 days after each vaccination and at 168 days after last vaccinationPopulation: Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available \& who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=7 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=9 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)
Baseline (Day 1)
|
7.74 Titers
Interval 2.72 to 22.0
|
27 Titers
Interval 3.75 to 191.0
|
8.78 Titers
Interval 1.2 to 64.0
|
6.91 Titers
Interval 2.03 to 24.0
|
6.37 Titers
Interval 2.38 to 17.0
|
4.71 Titers
Interval 2.02 to 11.0
|
|
Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)
One month after first vac.
|
23 Titers
Interval 6.13 to 86.0
|
141 Titers
Interval 21.0 to 962.0
|
186 Titers
Interval 40.0 to 855.0
|
157 Titers
Interval 45.0 to 546.0
|
6.35 Titers
Interval 2.61 to 15.0
|
6.2 Titers
Interval 1.97 to 20.0
|
|
Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)
One month after second vac.
|
41 Titers
Interval 11.0 to 148.0
|
314 Titers
Interval 60.0 to 1646.0
|
111 Titers
Interval 17.0 to 717.0
|
193 Titers
Interval 52.0 to 707.0
|
6.56 Titers
Interval 2.5 to 17.0
|
18 Titers
Interval 6.95 to 49.0
|
|
Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)
One month after third vac.
|
67 Titers
Interval 17.0 to 269.0
|
486 Titers
Interval 120.0 to 1959.0
|
149 Titers
Interval 17.0 to 1289.0
|
159 Titers
Interval 47.0 to 539.0
|
7.71 Titers
Interval 2.31 to 26.0
|
32 Titers
Interval 10.0 to 98.0
|
|
Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)
Six months after third vac.
|
42 Titers
Interval 9.96 to 178.0
|
418 Titers
Interval 87.0 to 2002.0
|
106 Titers
Interval 9.89 to 1143.0
|
102 Titers
Interval 27.0 to 383.0
|
5.05 Titers
Interval 1.65 to 15.0
|
12 Titers
Interval 2.66 to 57.0
|
SECONDARY outcome
Timeframe: At 28 days after each vaccination and 168 days after last vaccinationPopulation: Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available \& who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis
Seroresponse is defined as: If half of the baseline value is greater than 25 ELISA Unit (EU) then an increase of at least 50% in the post-vaccination sample as compared to baseline \[i.e. ((Post-vac minus baseline)/baseline)100% ≥ 50%\]. If half of the baseline value is less or equal to 25 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e. \[post-vac minus baseline\] ≥25 EU)
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=7 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=9 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Seroresponse for Anti-LPS S. Sonnei
One month after first vac.
|
3 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Seroresponse for Anti-LPS S. Sonnei
One month after second vac.
|
5 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Seroresponse for Anti-LPS S. Sonnei
One month after third vac.
|
7 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Seroresponse for Anti-LPS S. Sonnei
Six months after third vac.
|
6 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At baseline, at 28 days after each vaccination and at 168 days after last vaccinationPopulation: Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available \& who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis
High seroresponse is defined as a post vaccination titer ≥X anti-LPS serum IgG units in the GSK (former Novartis) ELISA that correspond to a titer of 1:800 in the ELISA method used by Cohen et al. To determine the value for 'X' the GSK (former Novartis) anti-LPS ELISA was calibrated against the Cohen ELISA and it was found that a concentration of 121 EU EU/mL corresponds to a titer of 1:800 in the Cohen assay
Outcome measures
| Measure |
S. Sonnei 1790GAHB - 5 mcg
n=9 Participants
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 Participants
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=7 Participants
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=9 Participants
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 Participants
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
S. Sonnei 1790GAHB - 1 mcg
n=8 Participants
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
|---|---|---|---|---|---|---|
|
Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)
Baseline
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)
One month after first vac.
|
2 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)
One month after second vac.
|
3 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)
One month after third vac.
|
5 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)
Six months after third vac.
|
2 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
S. Sonnei 1790GAHB - 1 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
S. Sonnei 1790GAHB - 5 mcg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
S. Sonnei 1790GAHB - 25 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
S. Sonnei 1790GAHB - 50 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
S. Sonnei 1790GAHB - 100 mcg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
S. Sonnei 1790GAHB - 1 mcg
n=8 participants at risk
Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 5 mcg
n=9 participants at risk
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 25 mcg
n=8 participants at risk
Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 50 mcg
n=8 participants at risk
Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB
|
S. Sonnei 1790GAHB - 100 mcg
n=9 participants at risk
Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB
|
Placebo
n=8 participants at risk
2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo
|
|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Rhinoplasty
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
General disorders
Chills
|
25.0%
2/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 6 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
33.3%
3/9 • Number of events 8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
75.0%
6/8 • Number of events 8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
62.5%
5/8 • Number of events 13 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
55.6%
5/9 • Number of events 9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
62.5%
5/8 • Number of events 11 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
General disorders
Injection site erythema
|
37.5%
3/8 • Number of events 6 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
37.5%
3/8 • Number of events 6 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
62.5%
5/8 • Number of events 9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
77.8%
7/9 • Number of events 14 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
25.0%
2/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
General disorders
Injection site induration
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
37.5%
3/8 • Number of events 5 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
37.5%
3/8 • Number of events 7 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
66.7%
6/9 • Number of events 12 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
25.0%
2/8 • Number of events 4 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
General disorders
Injection site pain
|
100.0%
8/8 • Number of events 20 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
100.0%
9/9 • Number of events 19 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
100.0%
8/8 • Number of events 23 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
100.0%
8/8 • Number of events 22 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
100.0%
9/9 • Number of events 26 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
75.0%
6/8 • Number of events 17 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
General disorders
Malaise
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
22.2%
2/9 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
25.0%
2/8 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
37.5%
3/8 • Number of events 5 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
33.3%
3/9 • Number of events 6 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Nervous system disorders
Headache
|
62.5%
5/8 • Number of events 13 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
33.3%
3/9 • Number of events 13 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
62.5%
5/8 • Number of events 7 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
62.5%
5/8 • Number of events 12 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
22.2%
2/9 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
62.5%
5/8 • Number of events 14 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Nervous system disorders
Morton's neuralgia
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Nervous system disorders
Sciatica
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Eye disorders
Conjunctivitis allergic
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Eye disorders
Myopia
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
37.5%
3/8 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
25.0%
2/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
33.3%
3/9 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
25.0%
2/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
62.5%
5/8 • Number of events 5 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
37.5%
3/8 • Number of events 5 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
50.0%
4/8 • Number of events 7 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
55.6%
5/9 • Number of events 10 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
37.5%
3/8 • Number of events 6 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Cystitis
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
11.1%
1/9 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Rhinitis
|
25.0%
2/8 • Number of events 2 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
37.5%
3/8 • Number of events 3 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
12.5%
1/8 • Number of events 1 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/9 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
0.00%
0/8 • Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
|
Additional Information
Dr. Audino Podda
GSK Vaccines Institute for Global Health S.r.l.
Phone: +39 0577 243496
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Trial results may not be published or disclosed in any other way by the Institution, without the prior written consent by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER