Trial Outcomes & Findings for A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants (NCT NCT04645966)
NCT ID: NCT04645966
Last Updated: 2024-03-25
Results Overview
Percentage of participants achieving hSBA titer greater than or equal to (\>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
326 participants
Primary outcome timeframe
1 month after primary vaccination 2
Results posted on
2024-03-25
Participant Flow
326 participants signed the informed consent form and were enrolled in the study. Out of which 1 participant was not vaccinated as parent withdrew consent. 325 participants received vaccination. The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.
Participant milestones
| Measure |
Group 1 (MenABCWY +PLP)
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 milliliter (mL) Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) into left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Prophylactic liquid paracetamol regimen (PLP) was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination (Day 1 \[primary vaccination {vacc}1\] and Month 2 \[primary vaccination 2\]). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into right thigh on Day 1.
|
Group 2 (MenABCWY)
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All subjects received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at Day 1.
|
Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 microgram \[mcg\]) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP or SLP was administered orally. Participants received a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 4 (60 mcg rLP2086 +Nimenrix)
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 7 (MenABCWY +SLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.5 mL MenABCWY approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. No participants received booster dose due to study termination.
|
Group 8 (Bexsero +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 10 (Bexsero +Nimenrix)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1), Month 2 (primary vaccination 2) and at approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 11 (MenABCWY +TLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). Therapeutic Liquid Paracetamol regimen (TLP) was administered orally. No participants received Vaccination 2 and booster dose due to study termination. All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Vaccination Phase
STARTED
|
23
|
25
|
36
|
16
|
53
|
50
|
55
|
55
|
12
|
|
Vaccination Phase
Primary Vaccination 1
|
23
|
25
|
39
|
16
|
50
|
50
|
55
|
55
|
12
|
|
Vaccination Phase
Primary Vaccination 2
|
22
|
25
|
23
|
16
|
50
|
42
|
54
|
55
|
0
|
|
Vaccination Phase
Booster Vaccination
|
22
|
25
|
22
|
4
|
9
|
0
|
47
|
45
|
0
|
|
Vaccination Phase
COMPLETED
|
22
|
25
|
20
|
0
|
2
|
0
|
25
|
22
|
0
|
|
Vaccination Phase
NOT COMPLETED
|
1
|
0
|
16
|
16
|
51
|
50
|
30
|
33
|
12
|
|
Follow-up Phase
STARTED
|
22
|
25
|
20
|
0
|
2
|
0
|
25
|
22
|
0
|
|
Follow-up Phase
COMPLETED
|
22
|
25
|
20
|
0
|
2
|
0
|
25
|
21
|
0
|
|
Follow-up Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (MenABCWY +PLP)
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 milliliter (mL) Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) into left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Prophylactic liquid paracetamol regimen (PLP) was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination (Day 1 \[primary vaccination {vacc}1\] and Month 2 \[primary vaccination 2\]). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into right thigh on Day 1.
|
Group 2 (MenABCWY)
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All subjects received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at Day 1.
|
Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 microgram \[mcg\]) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP or SLP was administered orally. Participants received a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 4 (60 mcg rLP2086 +Nimenrix)
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 7 (MenABCWY +SLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.5 mL MenABCWY approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. No participants received booster dose due to study termination.
|
Group 8 (Bexsero +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 10 (Bexsero +Nimenrix)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1), Month 2 (primary vaccination 2) and at approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 11 (MenABCWY +TLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). Therapeutic Liquid Paracetamol regimen (TLP) was administered orally. No participants received Vaccination 2 and booster dose due to study termination. All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Vaccination Phase
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Vaccination Phase
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Vaccination Phase
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Vaccination Phase
Study terminated by sponsor
|
0
|
0
|
14
|
15
|
47
|
43
|
29
|
29
|
12
|
|
Vaccination Phase
Withdrawal by parent/guardian
|
0
|
0
|
2
|
1
|
3
|
4
|
0
|
2
|
0
|
|
Vaccination Phase
Other
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Vaccination Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Vaccination Phase
No longer meets eligibility criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Follow-up Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
Baseline characteristics by cohort
| Measure |
Group 1 (MenABCWY +PLP)
n=23 Participants
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 milliliter (mL) Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) into left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Prophylactic liquid paracetamol regimen (PLP) was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination (Day 1 \[primary vaccination {vacc}1\] and Month 2 \[primary vaccination 2\]). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into right thigh on Day 1.
|
Group 2 (MenABCWY)
n=25 Participants
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All subjects received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at Day 1.
|
Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP)
n=36 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 microgram \[mcg\]) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP or SLP was administered orally. Participants received a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 4 (60 mcg rLP2086 +Nimenrix)
n=16 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
n=53 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 7 (MenABCWY +SLP)
n=50 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.5 mL MenABCWY approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. No participants received booster dose due to study termination.
|
Group 8 (Bexsero +Nimenrix +PLP)
n=55 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 10 (Bexsero +Nimenrix)
n=55 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1), Month 2 (primary vaccination 2) and at approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 11 (MenABCWY +TLP)
n=12 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). Therapeutic Liquid Paracetamol regimen (TLP) was administered orally. No participants received Vaccination 2 and booster dose due to study termination. All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 months of age.
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
158.5 Days
STANDARD_DEVIATION 6.87 • n=5 Participants
|
161.6 Days
STANDARD_DEVIATION 14.45 • n=7 Participants
|
71.1 Days
STANDARD_DEVIATION 7.00 • n=5 Participants
|
67.6 Days
STANDARD_DEVIATION 5.81 • n=4 Participants
|
68.9 Days
STANDARD_DEVIATION 6.39 • n=21 Participants
|
68.0 Days
STANDARD_DEVIATION 5.99 • n=10 Participants
|
67.4 Days
STANDARD_DEVIATION 7.89 • n=115 Participants
|
67.5 Days
STANDARD_DEVIATION 7.30 • n=24 Participants
|
69.4 Days
STANDARD_DEVIATION 7.69 • n=42 Participants
|
81.9 Days
STANDARD_DEVIATION 33.51 • n=42 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
160 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
35 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
165 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
22 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
132 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
33 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
193 Participants
n=42 Participants
|
|
Ethnicity (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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
55 Participants
n=115 Participants
|
55 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
319 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 1 month after primary vaccination 2Population: Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.
Percentage of participants achieving hSBA titer greater than or equal to (\>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=16 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=92 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MenA
|
100.0 Percentage of participants
Interval 79.4 to 100.0
|
100.0 Percentage of participants
Interval 96.0 to 100.0
|
—
|
|
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MenC
|
100.0 Percentage of participants
Interval 79.4 to 100.0
|
100.0 Percentage of participants
Interval 96.0 to 100.0
|
—
|
|
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MenW
|
100.0 Percentage of participants
Interval 79.4 to 100.0
|
100.0 Percentage of participants
Interval 96.0 to 100.0
|
—
|
|
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MenY
|
100.0 Percentage of participants
Interval 79.4 to 100.0
|
100.0 Percentage of participants
Interval 96.1 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 1 month after booster vaccinationPopulation: Post-booster vaccination EIP: randomized participants eligible through V6;received vaccine at V1, V3, V5;blood drawn for assay testing within required timeframes at V6; had at least 1 valid, determinate MenA, MenC, MenW, MenY, or MenB assay result at V6; received no prohibited vaccines/treatment and had no protocol deviations through V6. Here, ''N''=participants evaluable for the outcome measure and ''n''=participants evaluable for specific rows.
Percentage of participants achieving hSBA titer \>= LLOQ (1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.
Outcome measures
| Measure |
Group 7 and 11 Combined
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=42 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MenA
|
—
|
100.0 Percentage of participants
Interval 91.4 to 100.0
|
—
|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MenC
|
—
|
100.0 Percentage of participants
Interval 91.4 to 100.0
|
—
|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MenW
|
—
|
100.0 Percentage of participants
Interval 91.6 to 100.0
|
—
|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MenY
|
—
|
100.0 Percentage of participants
Interval 91.4 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 1 month After primary vaccination 2Population: Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.
Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=18 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=95 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
PMB80 (A22)
|
44.4 Percentage of participants
Interval 21.5 to 69.2
|
9.6 Percentage of participants
Interval 4.5 to 17.4
|
—
|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
PMB2707 (B44)
|
88.9 Percentage of participants
Interval 65.3 to 98.6
|
29.5 Percentage of participants
Interval 20.6 to 39.7
|
—
|
PRIMARY outcome
Timeframe: 1 month after primary vaccination 2Population: Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.
Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain(1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=35 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=45 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5
PMB80 (A22)
|
46.7 Percentage of participants
Interval 28.3 to 65.7
|
47.7 Percentage of participants
Interval 32.5 to 63.3
|
—
|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5
PMB2707 (B44)
|
82.9 Percentage of participants
Interval 66.4 to 93.4
|
97.8 Percentage of participants
Interval 88.2 to 99.9
|
—
|
PRIMARY outcome
Timeframe: 1 Month after booster vaccinationPopulation: Post booster vacc. evaluable immunogenicity population=randomised to study group of interest,eligible through V6. Received investigational products at V1,3,5 as randomised,blood drawn for assay testing at required time frames at V6(1 month after booster vacc\[28-42 days\]).At least 1 valid,determinate MenA, C, W, Y,or B assay result at V6, received no prohibited vaccines/treatment, no protocol deviations through V6.''N''=participants evaluable here; ''n''=participants evaluable for specific rows.
Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.
Outcome measures
| Measure |
Group 7 and 11 Combined
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=41 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
PMB80 (A22)
|
—
|
25.0 Percentage of participants
Interval 12.7 to 41.2
|
—
|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
PMB2707 (B44)
|
—
|
34.1 Percentage of participants
Interval 20.1 to 50.6
|
—
|
PRIMARY outcome
Timeframe: 1 Month after booster vaccinationPopulation: Post booster vacc. evaluable immunogenicity population=randomised to study group of interest,eligible through V6. Received investigational products at V1,3,5 as randomised,blood drawn for assay testing at required time frames at V6(1 month after booster vacc\[28-42 days\]).At least 1 valid,determinate MenA, C, W, Y,or B assay result at V6, received no prohibited vaccines/treatment, no protocol deviations through V6.''N''=participants evaluable here.
Percentage of participants achieving hSBA titer \>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. Groups 4 and 5 had no serum samples collected post-booster for serology testing due to study termination.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=18 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5
PMB80 (A22)
|
38.9 Percentage of participants
Interval 17.3 to 64.3
|
—
|
—
|
|
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5
PMB2707 (B44)
|
83.3 Percentage of participants
Interval 58.6 to 96.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after primary vaccination 1Population: Primary vaccination 1 safety population included all randomised participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=62 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=108 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Redness: Moderate
|
11.3 Percentage of participants
Interval 4.7 to 21.9
|
6.5 Percentage of participants
Interval 2.6 to 12.9
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Redness: Mild
|
22.6 Percentage of participants
Interval 12.9 to 35.0
|
23.1 Percentage of participants
Interval 15.6 to 32.2
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Swelling: Mild
|
21.0 Percentage of participants
Interval 11.7 to 33.2
|
22.2 Percentage of participants
Interval 14.8 to 31.2
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Swelling: Moderate
|
17.7 Percentage of participants
Interval 9.2 to 29.5
|
12.0 Percentage of participants
Interval 6.6 to 19.7
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Tenderness at injection site: Mild
|
22.6 Percentage of participants
Interval 12.9 to 35.0
|
25.9 Percentage of participants
Interval 18.0 to 35.2
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Tenderness at injection site: Moderate
|
48.4 Percentage of participants
Interval 35.5 to 61.4
|
24.1 Percentage of participants
Interval 16.4 to 33.3
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Tenderness at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days after primary Vaccination 2Population: Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=41 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=107 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Redness: Mild
|
26.8 Percentage of participants
Interval 14.2 to 42.9
|
27.1 Percentage of participants
Interval 19.0 to 36.6
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Redness: Moderate
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
11.2 Percentage of participants
Interval 5.9 to 18.8
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 8.6
|
0 Percentage of participants
Interval 0.0 to 3.4
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Swelling: Mild
|
19.5 Percentage of participants
Interval 8.8 to 34.9
|
25.2 Percentage of participants
Interval 17.3 to 34.6
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Swelling: Moderate
|
14.6 Percentage of participants
Interval 5.6 to 29.2
|
12.1 Percentage of participants
Interval 6.6 to 19.9
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 8.6
|
0 Percentage of participants
Interval 0.0 to 3.4
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Tenderness at injection site: Mild
|
22.0 Percentage of participants
Interval 10.6 to 37.6
|
27.1 Percentage of participants
Interval 19.0 to 36.6
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Tenderness at injection site: Moderate
|
34.1 Percentage of participants
Interval 20.1 to 50.6
|
23.4 Percentage of participants
Interval 15.7 to 32.5
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Tenderness at injection site: Severe
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
2.8 Percentage of participants
Interval 0.6 to 8.0
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days after primary Vaccination 1Population: Primary vaccination 1 safety population included all randomized participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method
Outcome measures
| Measure |
Group 7 and 11 Combined
n=62 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=108 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Irritability: Moderate
|
59.7 Percentage of participants
Interval 46.4 to 71.9
|
45.4 Percentage of participants
Interval 35.8 to 55.2
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Decreased appetite: Mild
|
17.7 Percentage of participants
Interval 9.2 to 29.5
|
17.6 Percentage of participants
Interval 10.9 to 26.1
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Fever: 38.0°C to 38.4°C
|
29.0 Percentage of participants
Interval 18.2 to 41.9
|
15.7 Percentage of participants
Interval 9.4 to 24.0
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Fever: >38.4°C to 38.9°C
|
24.2 Percentage of participants
Interval 14.2 to 36.7
|
5.6 Percentage of participants
Interval 2.1 to 11.7
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Fever: >38.9°C to 40.0°C
|
9.7 Percentage of participants
Interval 3.6 to 19.9
|
0 Percentage of participants
Interval 0.0 to 3.4
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Fever: >40.0°C
|
0 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Decreased appetite: Moderate
|
43.5 Percentage of participants
Interval 31.0 to 56.7
|
21.3 Percentage of participants
Interval 14.0 to 30.2
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Decreased appetite: Severe
|
4.8 Percentage of participants
Interval 1.0 to 13.5
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Irritability: Mild
|
21.0 Percentage of participants
Interval 11.7 to 33.2
|
19.4 Percentage of participants
Interval 12.5 to 28.2
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Irritability: Severe
|
14.5 Percentage of participants
Interval 6.9 to 25.8
|
6.5 Percentage of participants
Interval 2.6 to 12.9
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Drowsiness: Mild
|
37.1 Percentage of participants
Interval 25.2 to 50.3
|
39.8 Percentage of participants
Interval 30.5 to 49.7
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Drowsiness: Moderate
|
32.3 Percentage of participants
Interval 20.9 to 45.3
|
18.5 Percentage of participants
Interval 11.7 to 27.1
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Drowsiness: Severe
|
4.8 Percentage of participants
Interval 1.0 to 13.5
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Use of antipyretic medication
|
46.8 Percentage of participants
Interval 34.0 to 59.9
|
50.0 Percentage of participants
Interval 40.2 to 59.8
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after primary vaccination 2Population: Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 deg C and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness was graded as Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=41 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=107 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Irritability: Moderate
|
53.7 Percentage of participants
Interval 37.4 to 69.3
|
48.6 Percentage of participants
Interval 38.8 to 58.5
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Fever: 38.0°C to 38.4°C
|
26.8 Percentage of participants
Interval 14.2 to 42.9
|
31.8 Percentage of participants
Interval 23.1 to 41.5
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Fever: >38.4°C to 38.9°C
|
26.8 Percentage of participants
Interval 14.2 to 42.9
|
14.0 Percentage of participants
Interval 8.1 to 22.1
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Fever: >38.9°C to 40.0°C
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
2.8 Percentage of participants
Interval 0.6 to 8.0
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Fever: >40.0°C
|
0 Percentage of participants
Interval 0.0 to 8.6
|
0 Percentage of participants
Interval 0.0 to 3.4
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Decreased appetite: Mild
|
22.0 Percentage of participants
Interval 10.6 to 37.6
|
20.6 Percentage of participants
Interval 13.4 to 29.5
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Decreased appetite: Moderate
|
31.7 Percentage of participants
Interval 18.1 to 48.1
|
25.2 Percentage of participants
Interval 17.3 to 34.6
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Decreased appetite: Severe
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
3.7 Percentage of participants
Interval 1.0 to 9.3
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Irritability: Mild
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
21.5 Percentage of participants
Interval 14.1 to 30.5
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Irritability: Severe
|
22.0 Percentage of participants
Interval 10.6 to 37.6
|
6.5 Percentage of participants
Interval 2.7 to 13.0
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Drowsiness: Mild
|
29.3 Percentage of participants
Interval 16.1 to 45.5
|
45.8 Percentage of participants
Interval 36.1 to 55.7
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Drowsiness: Moderate
|
34.1 Percentage of participants
Interval 20.1 to 50.6
|
14.0 Percentage of participants
Interval 8.1 to 22.1
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Drowsiness: Severe
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Use of antipyretic medication
|
41.5 Percentage of participants
Interval 26.3 to 57.9
|
72.9 Percentage of participants
Interval 63.4 to 81.0
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after primary vaccination 1Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Medically attended adverse event (MAE) was defined as a nonserious AE that resulted in an evaluation at a medical facility. Newly diagnosed chronic medical condition (NDCMC) was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=62 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=110 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
AEs
|
24.2 Percentage of participants
|
16.4 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
SAEs
|
4.8 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MAEs
|
14.5 Percentage of participants
|
10.0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
NDCMCs
|
0 Percentage of participants
|
0.9 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after primary vaccination 2Population: Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that wasis expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=42 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=109 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
AEs
|
33.3 Percentage of participants
|
12.8 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
SAEs
|
2.4 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
MAEs
|
23.8 Percentage of participants
|
11.0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
NDCMC
|
0 Percentage of participants
|
0.9 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after any primary vaccinationPopulation: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that is was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=62 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=110 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
AEs
|
40.3 Percentage of participants
|
24.5 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
SAEs
|
6.5 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MAEs
|
29.0 Percentage of participants
|
16.4 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
NDCMC
|
0 Percentage of participants
|
0.9 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=62 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=110 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
AEs
|
56.5 Percentage of participants
|
33.6 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
SAEs
|
6.5 Percentage of participants
|
1.8 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MAEs
|
43.5 Percentage of participants
|
24.5 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
NDCMC
|
1.6 Percentage of participants
|
0.9 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From 1 month after primary vaccination 2 up to booster vaccinationPopulation: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=41 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=109 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined
AEs
|
17.1 Percentage of participants
|
18.3 Percentage of participants
|
—
|
|
Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined
SAEs
|
4.9 Percentage of participants
|
2.8 Percentage of participants
|
—
|
|
Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined
MAEs
|
12.2 Percentage of participants
|
15.6 Percentage of participants
|
—
|
|
Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined
NDCMC
|
0 Percentage of participants
|
0.9 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months)Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=62 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=110 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MAEs
|
45.2 Percentage of participants
|
30.0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
AEs
|
59.7 Percentage of participants
|
40.0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
SAEs
|
9.7 Percentage of participants
|
4.5 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
NDCMC
|
1.6 Percentage of participants
|
1.8 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 30 minutes After primary vaccination 1Population: Primary vaccination 1 safety population included all participants who received the first dose of investigational product at Visit 1 and who had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=62 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=110 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 30 minutes After primary vaccination 2Population: Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure.
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=42 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=109 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 30 minutes after booster vaccinationPopulation: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Outcome measures
| Measure |
Group 7 and 11 Combined
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=92 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
|
—
|
0 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days after booster vaccinationPopulation: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement.
Outcome measures
| Measure |
Group 7 and 11 Combined
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=92 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Redness
|
—
|
38 Participants
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Swelling
|
—
|
35 Participants
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Tenderness at injection site
|
—
|
63 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after booster vaccinationPopulation: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 deg C, categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was graded as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
Group 7 and 11 Combined
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=91 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Fever: 38.0°C to 38.4°C
|
—
|
19.8 Percentage of participants
Interval 12.2 to 29.4
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Fever: >38.4°C to 38.9°C
|
—
|
11.0 Percentage of participants
Interval 5.4 to 19.3
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Fever: >38.9°C to 40.0°C
|
—
|
4.4 Percentage of participants
Interval 1.2 to 10.9
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Fever: >40.0°C
|
—
|
0 Percentage of participants
Interval 0.0 to 4.0
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Decreased appetite: Mild
|
—
|
17.6 Percentage of participants
Interval 10.4 to 27.0
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Decreased appetite: Moderate
|
—
|
27.5 Percentage of participants
Interval 18.6 to 37.8
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Decreased appetite: Severe
|
—
|
2.2 Percentage of participants
Interval 0.3 to 7.7
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Irritability: Mild
|
—
|
22.0 Percentage of participants
Interval 14.0 to 31.9
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Irritability: Moderate
|
—
|
42.9 Percentage of participants
Interval 32.5 to 53.7
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Irritability: Severe
|
—
|
7.7 Percentage of participants
Interval 3.1 to 15.2
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Drowsiness: Mild
|
—
|
26.4 Percentage of participants
Interval 17.7 to 36.7
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Drowsiness: Moderate
|
—
|
18.7 Percentage of participants
Interval 11.3 to 28.2
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Drowsiness: Severe
|
—
|
1.1 Percentage of participants
Interval 0.0 to 6.0
|
—
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Use of antipyretic medication
|
—
|
63.7 Percentage of participants
Interval 53.0 to 73.6
|
—
|
PRIMARY outcome
Timeframe: From date of booster vaccination through 1 month after booster vaccinationPopulation: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Group 7 and 11 Combined
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=92 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
AEs
|
—
|
27.2 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
SAEs
|
—
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MAEs
|
—
|
92 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
NDCMC
|
—
|
0 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months)Population: Booster vaccination follow-up safety population included participants who received the booster dose of investigational product and who had safety follow-up between Visit 6 and up to and including Visit 7 (after booster vaccination). Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Group 7 and 11 Combined
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=92 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
AEs
|
—
|
17.4 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
SAEs
|
—
|
2.2 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MAEs
|
—
|
15.2 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
NDCMC
|
—
|
0 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months)Population: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Group 7 and 11 Combined
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=92 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
AEs
|
—
|
40.2 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
SAEs
|
—
|
2.2 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
MAEs
|
—
|
25.0 Percentage of participants
|
—
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
NDCMC
|
—
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 Month after primary Vaccination 2Population: Post-primary vaccination 2 evaluable immunogenicity population: participants randomized to study group of interest; eligible through Visit(V)4; received vaccine at V1,V3;blood drawn for assay testing at required timeframes at V4; had at least 1 valid, determinate MenA, MenC, MenW, MenY, or MenB assay result at V4;received no prohibited vaccines/treatment,no protocol deviations through V4. Here,''N''= participants evaluable for the outcome measure;''n''= participants evaluable for specific rows.
GMTs were calculated by exponentiating mean logarithm of titers and CIs were calculated by exponentiating confidence limits based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=35 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=45 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5
PMB80 (A22)
|
13.9 Titers
Interval 10.8 to 18.0
|
15.3 Titers
Interval 12.1 to 19.3
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5
PMB2707 (B44)
|
25.0 Titers
Interval 19.9 to 31.4
|
25.0 Titers
Interval 19.9 to 31.4
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster vaccinationPopulation: Post-primary vaccination 2 evaluable immunogenicity population:eligible participants randomized through Visit(V)4;received vaccine at V1,V3;blood drawn for assay testing within required timeframes at V4;had at least 1 valid, determinate MenA, C, W, Y, or B assay result at V4;received no prohibited vaccines/treatment;no protocol deviation through V4. Here,''N''=participants evaluable for this outcome measure.
GMTs were calculated by exponentiating the mean logarithm of the titers and CIs were calculated by exponentiating the confidence limits based on the Student t distribution for the mean logarithm of the titers. No serum samples were collected after booster dose for groups 4 and 5 due to study termination.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=18 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5
PMB80 (A22)
|
21.8 Titers
95% Confidence Interval 11.1 • Interval 11.1 to 42.6
|
—
|
—
|
|
hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5
PMB2707 (B44)
|
25.4 Titers
95% Confidence Interval 12.6 • Interval 12.6 to 51.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 Days after primary Vaccination(Vac) 1 and 2Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure; ''n''= participants evaluable for specific rows.
Local reactions included pain at injection site, redness and swelling and were recorded by participant's in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site on left arm were reported in this outcome measure.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=36 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=16 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
n=53 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vacc1Redness:Moderate
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
0 Percentage of participants
Interval 0.0 to 20.6
|
3.8 Percentage of participants
Interval 0.5 to 13.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vaccination 1:Redness:Mild
|
27.8 Percentage of participants
Interval 14.2 to 45.2
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
13.2 Percentage of participants
Interval 5.5 to 25.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vacc1Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 9.7
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 6.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vacc1:Swelling: Mild
|
16.7 Percentage of participants
Interval 6.4 to 32.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
9.4 Percentage of participants
Interval 3.1 to 20.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vacc1:Swelling: Moderate
|
11.1 Percentage of participants
Interval 3.1 to 26.1
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
5.7 Percentage of participants
Interval 1.2 to 15.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vacc1:Swelling: Severe
|
0 Percentage of participants
Interval to 9.7
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 6.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac1Tenderness at inj.site:Mild
|
19.4 Percentage of participants
Interval 8.2 to 36.0
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
22.6 Percentage of participants
Interval 12.3 to 36.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac1Tenderness at inj.site: Moderate
|
41.7 Percentage of participants
Interval 25.5 to 59.2
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
20.8 Percentage of participants
Interval 10.8 to 34.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac1Tenderness at inj.site: Severe
|
0 Percentage of participants
Interval 0.0 to 9.7
|
0 Percentage of participants
Interval 0.0 to 20.6
|
1.9 Percentage of participants
Interval 0.0 to 10.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Redness: Mild
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
19.2 Percentage of participants
Interval 9.6 to 32.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Redness: Moderate
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 20.6
|
3.8 Percentage of participants
Interval 0.5 to 13.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 6.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Swelling: Mild
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
9.6 Percentage of participants
Interval 3.2 to 21.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 16.1
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
1.9 Percentage of participants
Interval 0.0 to 10.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Swelling Severe
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 6.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Tenderness at inj.site Mild
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
32.7 Percentage of participants
Interval 20.3 to 47.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Tenderness at inj.siteModerate
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
17.3 Percentage of participants
Interval 8.2 to 30.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Vac2Tenderness at inj.siteSevere
|
0 Percentage of participants
Interval 0.0 to 16.1
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
1.9 Percentage of participants
Interval 0.0 to 10.3
|
SECONDARY outcome
Timeframe: Within 7 Days after primary Vaccination 1 and 2Population: Primary vaccination 1 safety population included all randomized participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure; ''n''= participants evaluable for specific rows.
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Exact 2-sided CI was based on the Clopper and Pearson method. Decreased appetite was categorized as Grade 1:decreased interest in eating, Grade 2:decreased oral intake, Grade3: refusal to feed. Drowsiness: Grade 1 Increased or prolonged sleeping bouts,Grade2: Slightly subdued interfering with daily activity, Grade3; Disabling, not interested in usual daily activity. Irritability; Grade1: Easily consolable, Grade2: requiring increased attention, Grade 3: Inconsolable; crying could not be comforted.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=36 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=16 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
n=53 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1Fever>38.4°C to 38.9°C
|
27.8 Percentage of participants
Interval 14.2 to 45.2
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
17.0 Percentage of participants
Interval 8.1 to 29.8
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1Fever>38.9°C to 40.0°C
|
0 Percentage of participants
Interval 0.0 to 9.7
|
0 Percentage of participants
Interval 0.0 to 20.6
|
11.3 Percentage of participants
Interval 4.3 to 23.0
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1Decreasedappetite Severe
|
2.8 Percentage of participants
Interval 0.1 to 14.5
|
0 Percentage of participants
Interval 0.0 to 20.6
|
3.8 Percentage of participants
Interval 0.5 to 13.0
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1IrritabilityMild
|
16.7 Percentage of participants
Interval 6.4 to 32.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
5.7 Percentage of participants
Interval 1.2 to 15.7
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1IrritabilityModerate
|
58.3 Percentage of participants
Interval 40.8 to 74.5
|
75.0 Percentage of participants
Interval 47.6 to 92.7
|
58.5 Percentage of participants
Interval 44.1 to 71.9
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1IrritabilitySevere
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
6.3 Percentage of participants
Interval 0.22 to 30.2
|
13.2 Percentage of participants
Interval 5.5 to 25.3
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1DrowsinessMild
|
36.1 Percentage of participants
Interval 20.8 to 53.8
|
37.5 Percentage of participants
Interval 15.2 to 64.6
|
49.1 Percentage of participants
Interval 35.1 to 63.2
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1DrowsinessModerate
|
33.3 Percentage of participants
Interval 18.6 to 51.0
|
31.3 Percentage of participants
Interval 11.0 to 58.7
|
39.6 Percentage of participants
Interval 26.5 to 54.0
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1DrowsinessSevere
|
2.8 Percentage of participants
Interval 0.1 to 14.5
|
0 Percentage of participants
Interval 0.0 to 20.6
|
3.8 Percentage of participants
Interval 0.5 to 13.0
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Use of antipyretic medication
|
58.3 Percentage of participants
Interval 40.8 to 74.5
|
56.3 Percentage of participants
Interval 29.9 to 80.2
|
83.0 Percentage of participants
Interval 70.2 to 91.9
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2 >38.0°C to 38.4°C
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
25.0 Percentage of participants
Interval 7.3 to 52.4
|
28.8 Percentage of participants
Interval 17.1 to 43.1
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2 >>38.4°C to 38.9°C
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
25.0 Percentage of participants
Interval 7.3 to 52.4
|
25.0 Percentage of participants
Interval 14.0 to 38.9
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2>>38.9°C to 40.0°C
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 20.6
|
13.5 Percentage of participants
Interval 5.6 to 25.8
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2>40.0°C
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 6.8
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2Decreased appetiteMild
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
28.8 Percentage of participants
Interval 17.1 to 43.1
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2Decreased appetiteModerate
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
50.0 Percentage of participants
Interval 24.7 to 75.3
|
38.5 Percentage of participants
Interval 25.3 to 53.0
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2Decreased appetite Severe
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
5.8 Percentage of participants
Interval 1.2 to 15.9
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2 Irritability Mild
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
21.2 Percentage of participants
Interval 11.1 to 34.7
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2IrritabilityModerate
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
68.8 Percentage of participants
Interval 41.3 to 89.0
|
48.1 Percentage of participants
Interval 34.0 to 62.4
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2IrritabilitySevere
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
0 Percentage of participants
Interval 0.0 to 20.6
|
9.6 Percentage of participants
Interval 3.2 to 21.0
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2DrowsinessMild
|
47.6 Percentage of participants
Interval 25.7 to 70.2
|
43.8 Percentage of participants
Interval 19.8 to 70.1
|
40.4 Percentage of participants
Interval 27.0 to 54.9
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2DrowsinessModertae
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
28.8 Percentage of participants
Interval 17.1 to 43.1
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2DrowsinessSevere
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 20.6
|
3.8 Percentage of participants
Interval 0.5 to 13.2
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac2Use of antipyretic medication
|
81.0 Percentage of participants
Interval 58.1 to 94.6
|
87.5 Percentage of participants
Interval 61.7 to 98.4
|
86.5 Percentage of participants
Interval 74.2 to 94.4
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1Fever38.0°C to 38.4°C
|
30.6 Percentage of participants
Interval 16.3 to 48.1
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
35.8 Percentage of participants
Interval 23.1 to 50.2
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1Fever >40.0°C
|
0 Percentage of participants
Interval 0.0 to 9.7
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 6.7
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1Decreased appetite Mild
|
25.0 Percentage of participants
Interval 12.1 to 42.2
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
28.3 Percentage of participants
Interval 16.8 to 42.3
|
|
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Vac1Decreased appetite Moderate
|
22.2 Percentage of participants
Interval 10.1 to 39.2
|
43.8 Percentage of participants
Interval 19.8 to 70.1
|
34.0 Percentage of participants
Interval 21.5 to 48.3
|
SECONDARY outcome
Timeframe: Within 30 days after any vaccinationPopulation: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
Outcome measures
| Measure |
Group 7 and 11 Combined
n=36 Participants
Group 7: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. Group11: Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). TLP regimen was administered orally. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
|
Group 8 and 10 Combined
n=16 Participants
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
n=53 Participants
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
|---|---|---|---|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5
AEs
|
52.8 Percentage of participants
|
68.8 Percentage of participants
|
60.4 Percentage of participants
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5
SAEs
|
2.8 Percentage of participants
|
6.3 Percentage of participants
|
20.8 Percentage of participants
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5
MAEs
|
47.2 Percentage of participants
|
62.5 Percentage of participants
|
47.2 Percentage of participants
|
|
Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5
NDCMC
|
0 Percentage of participants
|
6.3 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Group 1 (MenABCWY +PLP)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Group 2 (MenABCWY)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP)
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Group 4 (60 mcg rLP2086 +Nimenrix)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Serious events: 11 serious events
Other events: 53 other events
Deaths: 0 deaths
Group 7 (MenABCWY +SLP)
Serious events: 5 serious events
Other events: 50 other events
Deaths: 1 deaths
Group 8 (Bexsero +Nimenrix +PLP)
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Group 10 (Bexsero +Nimenrix)
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Group 11 (MenABCWY +TLP)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (MenABCWY +PLP)
n=23 participants at risk
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 milliliter (mL) Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) into left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Prophylactic liquid paracetamol regimen (PLP) was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination (Day 1 \[primary vaccination {vacc}1\] and Month 2 \[primary vaccination 2\]). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into right thigh on Day 1.
|
Group 2 (MenABCWY)
n=25 participants at risk
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All subjects received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at Day 1.
|
Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP)
n=36 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 microgram \[mcg\]) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP or SLP was administered orally. Participants received a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 4 (60 mcg rLP2086 +Nimenrix)
n=16 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
n=53 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 7 (MenABCWY +SLP)
n=50 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.5 mL MenABCWY approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. No participants received booster dose due to study termination.
|
Group 8 (Bexsero +Nimenrix +PLP)
n=55 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 10 (Bexsero +Nimenrix)
n=55 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1), Month 2 (primary vaccination 2) and at approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 11 (MenABCWY +TLP)
n=12 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). Therapeutic Liquid Paracetamol regimen (TLP) was administered orally. No participants received Vaccination 2 and booster dose due to study termination. All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Eye disorders
Papilloedema
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.8%
2/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
2/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Gastroenteritis bacillus
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Human herpesvirus 7 infection
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.8%
2/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
Other adverse events
| Measure |
Group 1 (MenABCWY +PLP)
n=23 participants at risk
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 milliliter (mL) Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) into left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Prophylactic liquid paracetamol regimen (PLP) was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination (Day 1 \[primary vaccination {vacc}1\] and Month 2 \[primary vaccination 2\]). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into right thigh on Day 1.
|
Group 2 (MenABCWY)
n=25 participants at risk
Infant participants aged 6 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All subjects received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at Day 1.
|
Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP)
n=36 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 microgram \[mcg\]) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP or SLP was administered orally. Participants received a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 4 (60 mcg rLP2086 +Nimenrix)
n=16 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
n=53 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 7 (MenABCWY +SLP)
n=50 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.5 mL MenABCWY approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. No participants received booster dose due to study termination.
|
Group 8 (Bexsero +Nimenrix +PLP)
n=55 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 10 (Bexsero +Nimenrix)
n=55 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1), Month 2 (primary vaccination 2) and at approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
|
Group 11 (MenABCWY +TLP)
n=12 participants at risk
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). Therapeutic Liquid Paracetamol regimen (TLP) was administered orally. No participants received Vaccination 2 and booster dose due to study termination. All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Congenital, familial and genetic disorders
Congenital skin disorder
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Congenital, familial and genetic disorders
Odontogenic cyst
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.6%
2/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Endocrine disorders
Precocious puberty
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.0%
2/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.7%
3/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Gingival cyst
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Infantile colic
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
3/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Injection site erythema
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Injection site mass
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Injection site pain
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Injection site swelling
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Mass
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Pain
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Pyrexia
|
26.1%
6/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.0%
2/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.6%
2/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
7.5%
4/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.0%
4/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
9.1%
5/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Pyrexia (FEVER)
|
65.2%
15/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
76.0%
19/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
69.4%
25/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
62.5%
10/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
79.2%
42/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
76.0%
38/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
58.2%
32/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
70.9%
39/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
58.3%
7/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Swelling
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Swelling (SWELLING)
|
43.5%
10/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
56.0%
14/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
36.1%
13/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
31.2%
5/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
18.9%
10/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
52.0%
26/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
54.5%
30/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
56.4%
31/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.7%
2/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Tenderness (TENDERNESS)
|
87.0%
20/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
80.0%
20/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
63.9%
23/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
50.0%
8/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
66.0%
35/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
82.0%
41/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
74.5%
41/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
81.8%
45/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
66.7%
8/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
General disorders
Vaccination site pain
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Immune system disorders
Food allergy
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Bronchiolitis
|
8.7%
2/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.0%
4/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
3/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.5%
2/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.8%
2/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.0%
3/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Bronchitis
|
8.7%
2/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.0%
2/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
COVID-19
|
8.7%
2/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.0%
3/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
7.5%
4/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.0%
8/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
9.1%
5/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
10.9%
6/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Conjunctivitis
|
17.4%
4/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.0%
3/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
18.8%
3/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.7%
3/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
7.3%
4/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
7.3%
4/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Ear infection
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.6%
2/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Gastroenteritis
|
26.1%
6/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
32.0%
8/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.6%
2/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
7.3%
4/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
7.3%
4/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
28.0%
7/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Herpangina
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Impetigo
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Laryngitis
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.0%
3/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.6%
2/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.7%
3/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
2/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Mumps
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Nasopharyngitis
|
21.7%
5/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.0%
2/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.0%
3/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
9.1%
5/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Oral candidiasis
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Otitis media
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.0%
4/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.5%
2/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Otitis media acute
|
17.4%
4/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
24.0%
6/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.6%
2/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.8%
2/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Parvovirus B19 infection
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Pharyngitis
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.0%
3/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Respiratory tract infection
|
8.7%
2/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.0%
3/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Respiratory tract infection viral
|
17.4%
4/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
20.0%
5/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Skin candida
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Skin infection
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Tonsillitis
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.4%
4/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
20.0%
5/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.7%
6/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.5%
2/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
13.2%
7/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
14.0%
7/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
20.0%
11/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
20.0%
11/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
25.0%
3/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Vaccination site infection
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Viraemia
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Viral infection
|
17.4%
4/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.0%
2/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
7.3%
4/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.0%
3/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Head injury
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.8%
2/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.7%
2/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
|
78.3%
18/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
68.0%
17/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
69.4%
25/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
68.8%
11/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
86.8%
46/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
76.0%
38/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
67.3%
37/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
74.5%
41/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
75.0%
9/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.8%
2/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.7%
2/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Nervous system disorders
External hydrocephalus
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
|
78.3%
18/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
72.0%
18/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
88.9%
32/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
75.0%
12/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
94.3%
50/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
78.0%
39/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
80.0%
44/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
78.2%
43/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
83.3%
10/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Nervous system disorders
Motor developmental delay
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.7%
2/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Psychiatric disorders
Irritability
|
8.7%
2/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.0%
4/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
16.7%
2/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Psychiatric disorders
Irritability (IRRITABILITY)
|
95.7%
22/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
80.0%
20/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
88.9%
32/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
87.5%
14/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
94.3%
50/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
98.0%
49/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
80.0%
44/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
89.1%
49/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
100.0%
12/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.0%
3/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
8.7%
2/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
3.6%
2/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Erythema (REDNESS)
|
34.8%
8/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
52.0%
13/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
50.0%
18/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
37.5%
6/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
35.8%
19/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
44.0%
22/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
56.4%
31/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
63.6%
35/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
33.3%
4/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
6.2%
1/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
8.3%
1/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
4.0%
1/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.8%
1/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.5%
3/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.8%
1/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Infections and infestations
Viral rash
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.0%
3/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
12.5%
2/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Investigations
Cardiac murmur
|
0.00%
0/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
1.9%
1/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
|
Investigations
SARS-CoV-2 test positive
|
4.3%
1/23 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/25 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/36 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/16 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/53 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.0%
1/50 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/55 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/12 • Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER