Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease (NCT NCT05842967)
NCT ID: NCT05842967
Last Updated: 2025-08-08
Results Overview
Local reactions included pain at injection site, redness and swelling, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: \>2.5 cm to 5.0 cm; moderate: \>5.0 cm to 10.0 cm; severe: \>10 cm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
885 participants
Primary outcome timeframe
Within 7 Days after Vaccination (Vaccination on Day 1)
Results posted on
2025-08-08
Participant Flow
Substudy A (SSA) and substudy B (SSB) are reported differently. SSA was randomized; SSB was open-label single-arm. Enrollment number 885 derived from participants with IP assigned in SSA (681 randomized) and SSB (204). Since no randomization in SSB (single arm), tables of SSB present 217 participants as starting substudy (signed informed consent), out of which 203 vaccinated. In SSA: 678 vaccinated.
For immunogenicity analysis for SSA, as planned, data of participants \>=60 years vaccinated with RSVpreF in C3671013 \[NCT05035212\] study is used for comparison. These participants were not enrolled in the present study C3671023 \[NCT05842967\], only the relevant historical data was used for comparison as per the objectives.
Participant milestones
| Measure |
SSA: RSVpreF
Participants aged \>=18 to \<60 years received respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) 120 microgram (mcg) intramuscularly on Day 1 of SSA.
|
SSA: Placebo
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
SSB: RSVpreF, >= 18 to < 60 Years
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
SSB: RSVpreF, >= 60 Years
Participants aged \>=60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
|---|---|---|---|---|
|
Period 1: SSA
STARTED
|
454
|
227
|
0
|
0
|
|
Period 1: SSA
Vaccinated
|
453
|
225
|
0
|
0
|
|
Period 1: SSA
COMPLETED
|
432
|
218
|
0
|
0
|
|
Period 1: SSA
NOT COMPLETED
|
22
|
9
|
0
|
0
|
|
Period 2: SSB
STARTED
|
0
|
0
|
101
|
116
|
|
Period 2: SSB
Vaccinated
|
0
|
0
|
96
|
107
|
|
Period 2: SSB
COMPLETED
|
0
|
0
|
89
|
103
|
|
Period 2: SSB
NOT COMPLETED
|
0
|
0
|
12
|
13
|
Reasons for withdrawal
| Measure |
SSA: RSVpreF
Participants aged \>=18 to \<60 years received respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) 120 microgram (mcg) intramuscularly on Day 1 of SSA.
|
SSA: Placebo
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
SSB: RSVpreF, >= 18 to < 60 Years
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
SSB: RSVpreF, >= 60 Years
Participants aged \>=60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
|---|---|---|---|---|
|
Period 1: SSA
Adverse Event
|
1
|
1
|
0
|
0
|
|
Period 1: SSA
Death
|
1
|
0
|
0
|
0
|
|
Period 1: SSA
Lost to Follow-up
|
16
|
4
|
0
|
0
|
|
Period 1: SSA
Physician Decision
|
1
|
0
|
0
|
0
|
|
Period 1: SSA
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
|
Period 1: SSA
Randomized but not vaccinated
|
1
|
2
|
0
|
0
|
|
Period 2: SSB
Adverse Event
|
0
|
0
|
2
|
0
|
|
Period 2: SSB
Lost to Follow-up
|
0
|
0
|
4
|
3
|
|
Period 2: SSB
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Period 2: SSB
Enrolled but not vaccinated
|
0
|
0
|
5
|
9
|
|
Period 2: SSB
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease
Baseline characteristics by cohort
| Measure |
SSA: RSVpreF
n=453 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=225 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
SSB: RSVpreF, >= 18 to < 60 Years
n=96 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
SSB: RSVpreF, >= 60 Years
n=107 Participants
Participants aged \>=60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
Total
n=881 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18 to <60 years
|
453 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
774 Participants
n=21 Participants
|
|
Age, Customized
>=60 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
260 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
521 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
360 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
102 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
348 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
712 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
106 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
203 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
312 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
614 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days after Vaccination (Vaccination on Day 1)Population: E-diary safety population included all participants who received the study intervention with at least 1 day of e-diary data transmitted.
Local reactions included pain at injection site, redness and swelling, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: \>2.5 cm to 5.0 cm; moderate: \>5.0 cm to 10.0 cm; severe: \>10 cm.
Outcome measures
| Measure |
SSA: RSVpreF
n=451 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=225 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Mild
|
29.7 Percentage of Participants
Interval 25.5 to 34.2
|
10.2 Percentage of Participants
Interval 6.6 to 14.9
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Moderate
|
5.5 Percentage of Participants
Interval 3.6 to 8.1
|
0.4 Percentage of Participants
Interval 0.0 to 2.5
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Severe
|
0 Percentage of Participants
Interval 0.0 to 0.8
|
0 Percentage of Participants
Interval 0.0 to 1.6
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Mild
|
3.8 Percentage of Participants
Interval 2.2 to 6.0
|
0 Percentage of Participants
Interval 0.0 to 1.6
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Moderate
|
2.2 Percentage of Participants
Interval 1.1 to 4.0
|
0.4 Percentage of Participants
Interval 0.0 to 2.5
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Severe
|
0 Percentage of Participants
Interval 0.0 to 0.8
|
0 Percentage of Participants
Interval 0.0 to 1.6
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Mild
|
4.0 Percentage of Participants
Interval 2.4 to 6.2
|
0.4 Percentage of Participants
Interval 0.0 to 2.5
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Moderate
|
2.9 Percentage of Participants
Interval 1.5 to 4.9
|
0.4 Percentage of Participants
Interval 0.0 to 2.5
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Severe
|
0.2 Percentage of Participants
Interval 0.0 to 1.2
|
0 Percentage of Participants
Interval 0.0 to 1.6
|
PRIMARY outcome
Timeframe: Within 7 Days after Vaccination (Vaccination on Day 1)Population: E-diary safety population included all participants who received the study intervention with at least 1 day of e-diary data transmitted.
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C and severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, nausea, muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Outcome measures
| Measure |
SSA: RSVpreF
n=451 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=225 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: 38.0°C to 38.4°C
|
0.4 Percentage of participants
Interval 0.1 to 1.6
|
0.4 Percentage of participants
Interval 0.0 to 2.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.4°C to 38.9°C
|
1.1 Percentage of participants
Interval 0.4 to 2.6
|
0.9 Percentage of participants
Interval 0.1 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.9°C to 40.0°C
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 1.6
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Mild
|
18.2 Percentage of participants
Interval 14.7 to 22.1
|
22.2 Percentage of participants
Interval 17.0 to 28.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate
|
18.2 Percentage of participants
Interval 14.7 to 22.1
|
15.6 Percentage of participants
Interval 11.1 to 21.0
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Severe
|
0.9 Percentage of participants
Interval 0.2 to 2.3
|
0.4 Percentage of participants
Interval 0.0 to 2.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Mild
|
20.8 Percentage of participants
Interval 17.2 to 24.9
|
18.7 Percentage of participants
Interval 13.8 to 24.4
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Moderate
|
7.3 Percentage of participants
Interval 5.1 to 10.1
|
11.6 Percentage of participants
Interval 7.7 to 16.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Severe
|
0.2 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.6
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Mild
|
15.7 Percentage of participants
Interval 12.5 to 19.4
|
9.8 Percentage of participants
Interval 6.2 to 14.4
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Moderate
|
8.6 Percentage of participants
Interval 6.2 to 11.6
|
6.2 Percentage of participants
Interval 3.4 to 10.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Severe
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 1.6
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Mild
|
7.1 Percentage of participants
Interval 4.9 to 9.9
|
4.0 Percentage of participants
Interval 1.8 to 7.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Moderate
|
5.1 Percentage of participants
Interval 3.3 to 7.6
|
6.2 Percentage of participants
Interval 3.4 to 10.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Severe
|
0.2 Percentage of participants
Interval 0.0 to 1.2
|
0 Percentage of participants
Interval 0.0 to 1.6
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Mild
|
9.3 Percentage of participants
Interval 6.8 to 12.4
|
8.9 Percentage of participants
Interval 5.5 to 13.4
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Moderate
|
2.4 Percentage of participants
Interval 1.2 to 4.3
|
0.9 Percentage of participants
Interval 0.1 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Severe
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0.4 Percentage of participants
Interval 0.0 to 2.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Mild
|
1.6 Percentage of participants
Interval 0.6 to 3.2
|
0.4 Percentage of participants
Interval 0.0 to 2.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Moderate
|
0.4 Percentage of participants
Interval 0.1 to 1.6
|
0.9 Percentage of participants
Interval 0.1 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 0.8
|
0 Percentage of participants
Interval 0.0 to 1.6
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Mild
|
11.1 Percentage of participants
Interval 8.3 to 14.4
|
12.4 Percentage of participants
Interval 8.4 to 17.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Moderate
|
3.1 Percentage of participants
Interval 1.7 to 5.2
|
3.6 Percentage of participants
Interval 1.5 to 6.9
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Severe
|
0.7 Percentage of participants
Interval 0.1 to 1.9
|
0.9 Percentage of participants
Interval 0.1 to 3.2
|
PRIMARY outcome
Timeframe: Within 1 Month after Vaccination (Vaccination on Day 1)Population: Safety population included all enrolled participants who received the study intervention.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included. AEs included both serious and all non-serious adverse events.
Outcome measures
| Measure |
SSA: RSVpreF
n=453 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=225 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
|
7.1 Percentage of participants
Interval 4.9 to 9.8
|
7.6 Percentage of participants
Interval 4.5 to 11.8
|
PRIMARY outcome
Timeframe: Within 6 Months after Vaccination (Vaccination on Day 1)Population: Safety population included all enrolled participants who received the study intervention.
A NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions.
Outcome measures
| Measure |
SSA: RSVpreF
n=453 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=225 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Throughout the Study
|
0.7 Percentage of participants
Interval 0.1 to 1.9
|
2.2 Percentage of participants
Interval 0.7 to 5.1
|
PRIMARY outcome
Timeframe: Within 6 Months after Vaccination (Vaccination on Day 1)Population: Safety population included all enrolled participants who received the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event were included in this outcome measure.
Outcome measures
| Measure |
SSA: RSVpreF
n=453 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=225 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
|
1.1 Percentage of participants
Interval 0.4 to 2.6
|
3.1 Percentage of participants
Interval 1.3 to 6.3
|
PRIMARY outcome
Timeframe: At 1 Month after Vaccination (Vaccination on Day 1)Population: C3671023: Evaluable immunogenicity population: participants eligible for SSA; received study interventions (RSVpreF or placebo) to which they were randomized; had 1-month postvaccination blood collection 27-42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination up to 1-month postvaccination blood draw. C3671013: Immunogenicity subset. "Number Analyzed" = participants evaluable for specified rows.
In this outcome measure, GMTs for RSV A and RSV B neutralizing titers (NTs) are reported. In statistical section, GMT ratio estimated by the ratio of the GMTs for RSV A and RSV B serum NTs at 1 month after vaccination with RSVpreF in current study C3671023 participants to that in study C3671013 adults \>=60 years of age, is reported. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student t distribution).
Outcome measures
| Measure |
SSA: RSVpreF
n=437 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=408 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: Geometric Mean Ratio (GMR) Estimated by Ratio of the Geometric Mean Titers (GMTs) at 1 Month After Vaccination in Study C3671023 Participants Compared to Study C3671013 Adults >= 60 Years
RSV A
|
41097 Titer
Interval 37986.1 to 44463.4
|
26225 Titer
Interval 24143.1 to 28485.7
|
|
SSA: Geometric Mean Ratio (GMR) Estimated by Ratio of the Geometric Mean Titers (GMTs) at 1 Month After Vaccination in Study C3671023 Participants Compared to Study C3671013 Adults >= 60 Years
RSV B
|
37416 Titer
Interval 34277.9 to 40842.0
|
24680 Titer
Interval 22504.3 to 27065.4
|
PRIMARY outcome
Timeframe: At 1 Month after Vaccination (Vaccination on Day 1)Population: C3671023: Evaluable immunogenicity population: participants eligible for SSA; received study interventions (RSVpreF or placebo) to which they were randomized; had 1-month postvaccination blood collection 27-42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination up to 1-month postvaccination blood draw. C3671013: Immunogenicity subset. "Number Analyzed" = participants evaluable for specified rows.
Seroresponse was defined as achieving a \>=4-fold rise from baseline (before vaccination), if the baseline measurement was above the lower limit of quantitation (LLOQ). If the baseline measurement was below the LLOQ, a postvaccination assay result \>=4\* LLOQ was considered a seroresponse.
Outcome measures
| Measure |
SSA: RSVpreF
n=437 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=408 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: Percentage of Participants With Seroresponse Rate and Difference in Seroresponse Rates of RSV A and RSV B Serum NTs at 1 Month After Vaccination for Participants in Study C3671023 and C3671013 Adults >= 60 Years
RSV A
|
93.1 Percentage of participants
Interval 90.3 to 95.3
|
88.0 Percentage of participants
Interval 84.4 to 91.0
|
|
SSA: Percentage of Participants With Seroresponse Rate and Difference in Seroresponse Rates of RSV A and RSV B Serum NTs at 1 Month After Vaccination for Participants in Study C3671023 and C3671013 Adults >= 60 Years
RSV B
|
93.4 Percentage of participants
Interval 90.6 to 95.5
|
85.0 Percentage of participants
Interval 81.2 to 88.4
|
PRIMARY outcome
Timeframe: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1)Population: E-diary safety population included all participants who received the first dose of RSVpreF and had at least 1 day of e-diary data transferred during the Dose 1 e-diary collection period.
Local reactions included pain at injection site, redness and swelling, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: \> 2.0 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm and severe: \> 10 cm.
Outcome measures
| Measure |
SSA: RSVpreF
n=96 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=107 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Mild
|
25.0 Percentage of participants
Interval 16.7 to 34.9
|
16.8 Percentage of participants
Interval 10.3 to 25.3
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Moderate
|
1.0 Percentage of participants
Interval 0.0 to 5.7
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Mild
|
5.2 Percentage of participants
Interval 1.7 to 11.7
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Moderate
|
1.0 Percentage of participants
Interval 0.0 to 5.7
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Mild
|
6.3 Percentage of participants
Interval 2.3 to 13.1
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Moderate
|
2.1 Percentage of participants
Interval 0.3 to 7.3
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
PRIMARY outcome
Timeframe: Within 7 Days after Vaccination 2 (Vaccination 2: 1-month post-vaccination 1 on Day 1)Population: E-diary safety population included all participants who received 2 doses of RSVpreF and had at least 1 day of e-diary data transferred during the Dose 2 e-diary collection period. Here, 'Overall Number of Participants Analyzed' (N)= participants evaluable for this outcome measure.
Local reactions included pain at injection site, redness and swelling, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit = 0.5 cm. Redness and swelling were graded as mild: \>2.0 cm to 5.0 cm; moderate: \>5.0 cm to 10.0 cm and severe: \>10 cm.
Outcome measures
| Measure |
SSA: RSVpreF
n=94 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=105 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Mild
|
42.6 Percentage of participants
Interval 32.4 to 53.2
|
29.5 Percentage of participants
Interval 21.0 to 39.2
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Moderate
|
4.3 Percentage of participants
Interval 1.2 to 10.5
|
1.9 Percentage of participants
Interval 0.2 to 6.7
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Mild
|
2.1 Percentage of participants
Interval 0.3 to 7.5
|
1.9 Percentage of participants
Interval 0.2 to 6.7
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.8
|
1.9 Percentage of participants
Interval 0.2 to 6.7
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Mild
|
2.1 Percentage of participants
Interval 0.3 to 7.5
|
3.8 Percentage of participants
Interval 1.0 to 9.5
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Moderate
|
1.1 Percentage of participants
Interval 0.0 to 5.8
|
5.7 Percentage of participants
Interval 2.1 to 12.0
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
PRIMARY outcome
Timeframe: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1)Population: E-diary safety population included all participants who received the first dose of RSVpreF and had at least 1 day of e-diary data transferred during the Dose 1 e-diary collection period.
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C and severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, nausea, muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Outcome measures
| Measure |
SSA: RSVpreF
n=96 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=107 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: 38.0°C to 38.4°C
|
1.0 Percentage of participants
Interval 0.0 to 5.7
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.4°C to 38.9°C
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.9°C to 40.0°C
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Mild
|
20.8 Percentage of participants
Interval 13.2 to 30.3
|
19.6 Percentage of participants
Interval 12.6 to 28.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Moderate
|
16.7 Percentage of participants
Interval 9.8 to 25.6
|
22.4 Percentage of participants
Interval 14.9 to 31.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Severe
|
2.1 Percentage of participants
Interval 0.3 to 7.3
|
2.8 Percentage of participants
Interval 0.6 to 8.0
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Mild
|
29.2 Percentage of participants
Interval 20.3 to 39.3
|
15.0 Percentage of participants
Interval 8.8 to 23.1
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Moderate
|
9.4 Percentage of participants
Interval 4.4 to 17.1
|
6.5 Percentage of participants
Interval 2.7 to 13.0
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Mild
|
4.2 Percentage of participants
Interval 1.1 to 10.3
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Nausea: Mild
|
9.4 Percentage of participants
Interval 4.4 to 17.1
|
3.7 Percentage of participants
Interval 1.0 to 9.3
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Nausea: Moderate
|
3.1 Percentage of participants
Interval 0.6 to 8.9
|
4.7 Percentage of participants
Interval 1.5 to 10.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Nausea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Mild
|
15.6 Percentage of participants
Interval 9.0 to 24.5
|
12.1 Percentage of participants
Interval 6.6 to 19.9
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Moderate
|
6.3 Percentage of participants
Interval 2.3 to 13.1
|
5.6 Percentage of participants
Interval 2.1 to 11.8
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Muscle Pain: Mild
|
18.8 Percentage of participants
Interval 11.5 to 28.0
|
13.1 Percentage of participants
Interval 7.3 to 21.0
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Muscle Pain: Moderate
|
7.3 Percentage of participants
Interval 3.0 to 14.4
|
5.6 Percentage of participants
Interval 2.1 to 11.8
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Muscle Pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Joint Pain: Mild
|
10.4 Percentage of participants
Interval 5.1 to 18.3
|
11.2 Percentage of participants
Interval 5.9 to 18.8
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Joint Pain: Moderate
|
7.3 Percentage of participants
Interval 3.0 to 14.4
|
8.4 Percentage of participants
Interval 3.9 to 15.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Joint Pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
PRIMARY outcome
Timeframe: Within 7 Days after Vaccination 2 (Vaccination 2: 1-month post-vaccination 1 on Day 1)Population: E-diary safety population included all participants who received 2 doses of RSVpreF and had at least 1 day of e-diary data transferred during the Dose 2 e-diary collection period. Here, 'N'= participants evaluable for this outcome measure.
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C and severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, nausea, muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Outcome measures
| Measure |
SSA: RSVpreF
n=94 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=105 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: 38.0°C to 38.4°C
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >38.4°C to 38.9°C
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >38.9°C to 40.0°C
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Mild
|
19.1 Percentage of participants
Interval 11.8 to 28.6
|
23.8 Percentage of participants
Interval 16.0 to 33.1
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Moderate
|
18.1 Percentage of participants
Interval 10.9 to 27.4
|
19.0 Percentage of participants
Interval 12.0 to 27.9
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Mild
|
13.8 Percentage of participants
Interval 7.6 to 22.5
|
19.0 Percentage of participants
Interval 12.0 to 27.9
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Moderate
|
10.6 Percentage of participants
Interval 5.2 to 18.7
|
5.7 Percentage of participants
Interval 2.1 to 12.0
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Mild
|
2.1 Percentage of participants
Interval 0.3 to 7.5
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Nausea: Mild
|
5.3 Percentage of participants
Interval 1.7 to 12.0
|
5.7 Percentage of participants
Interval 2.1 to 12.0
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Nausea: Moderate
|
1.1 Percentage of participants
Interval 0.0 to 5.8
|
1.0 Percentage of participants
Interval 0.0 to 5.2
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Nausea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Mild
|
6.4 Percentage of participants
Interval 2.4 to 13.4
|
10.5 Percentage of participants
Interval 5.3 to 18.0
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Moderate
|
5.3 Percentage of participants
Interval 1.7 to 12.0
|
2.9 Percentage of participants
Interval 0.6 to 8.1
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Muscle Pain: Mild
|
16.0 Percentage of participants
Interval 9.2 to 25.0
|
15.2 Percentage of participants
Interval 9.0 to 23.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Muscle Pain: Moderate
|
3.2 Percentage of participants
Interval 0.7 to 9.0
|
8.6 Percentage of participants
Interval 4.0 to 15.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Muscle Pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Joint Pain: Mild
|
8.5 Percentage of participants
Interval 3.7 to 16.1
|
12.4 Percentage of participants
Interval 6.8 to 20.2
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Joint Pain: Moderate
|
3.2 Percentage of participants
Interval 0.7 to 9.0
|
4.8 Percentage of participants
Interval 1.6 to 10.8
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Joint Pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.5
|
PRIMARY outcome
Timeframe: From Vaccination 1 (on Day 1) through 1 month after Vaccination 2 (1 month after Vaccination 1) [approximately up to maximum of 2 months]Population: Safety population included all enrolled participants who received the study intervention.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included. AEs included both serious and all non-serious adverse events.
Outcome measures
| Measure |
SSA: RSVpreF
n=96 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=107 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: Percentage of Participants With AEs From Vaccination 1 Through 1 Month After Vaccination 2
|
13.5 Percentage of participants
Interval 7.4 to 22.0
|
22.4 Percentage of participants
Interval 14.9 to 31.5
|
PRIMARY outcome
Timeframe: From Vaccination 1 (on Day 1) through 6 months after Vaccination 2 (1 month after Vaccination 1) [approximately up to maximum of 7 months]Population: Safety population included all enrolled participants who received the study intervention.
A NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions.
Outcome measures
| Measure |
SSA: RSVpreF
n=96 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=107 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: Percentage of Participants With NDCMCs From Vaccination Throughout the Study
|
2.1 Percentage of participants
Interval 0.3 to 7.3
|
6.5 Percentage of participants
Interval 2.7 to 13.0
|
PRIMARY outcome
Timeframe: From Vaccination 1 (on Day 1) through 6 months after Vaccination 2 (1 month after Vaccination 1) [approximately up to maximum of 7 months]Population: Safety population included all enrolled participants who received the study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event were included in this outcome measure.
Outcome measures
| Measure |
SSA: RSVpreF
n=96 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=107 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: Percentage of Participants With SAEs Throughout the Study
|
7.3 Percentage of participants
Interval 3.0 to 14.4
|
14.0 Percentage of participants
Interval 8.1 to 22.1
|
PRIMARY outcome
Timeframe: Before Vaccination 1 (on Day 1)Population: Evaluable immunogenicity population included all eligible participants for SSB who received 2 dose of RSVpreF; (blood collected for 1 month after last dose to be 27-42 days after second dose of RSVpreF; had at least 1 valid, determinate assay result 1 month after vaccination (1 month after second dose of RSVpreF); had no major protocol violations from vaccination through 1-month postvaccination blood draw (1 month after second dose of RSVpreF).
GMT of RSV A and RSV B before vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
SSA: RSVpreF
n=90 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=98 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: GMT of NT for RSV A and RSV B Before Vaccination 1
RSV A
|
2943 Titer
Interval 2417.9 to 3580.9
|
3289 Titer
Interval 2735.1 to 3954.1
|
|
SSB: GMT of NT for RSV A and RSV B Before Vaccination 1
RSV B
|
2584 Titer
Interval 2120.6 to 3147.9
|
2992 Titer
Interval 2416.5 to 3704.1
|
PRIMARY outcome
Timeframe: 1 Month After Vaccination 1 (on Day 1)Population: Evaluable immunogenicity population included all eligible participants for SSB who received 2 dose of RSVpreF; (blood collected for 1 month after last dose to be 27-42 days after second dose of RSVpreF; had at least 1 valid, determinate assay result 1 month after vaccination (1 month after second dose of RSVpreF); had no major protocol violations from vaccination through 1-month postvaccination blood draw (1 month after second dose of RSVpreF).
GMT of RSV A and RSV B before vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
SSA: RSVpreF
n=90 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=98 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: GMT of NT for RSV A and RSV B 1 Month After Vaccination 1
RSV A
|
26173 Titer
Interval 19937.1 to 34359.2
|
26075 Titer
Interval 20513.1 to 33144.1
|
|
SSB: GMT of NT for RSV A and RSV B 1 Month After Vaccination 1
RSV B
|
24701 Titer
Interval 18300.5 to 33340.1
|
25384 Titer
Interval 19749.5 to 32626.2
|
PRIMARY outcome
Timeframe: 1 Month After Vaccination 2 (1-month post Vaccination 1)Population: Evaluable immunogenicity population included all eligible participants for SSB who received 2 dose of RSVpreF; (blood collected for 1 month after last dose to be 27-42 days after second dose of RSVpreF; had at least 1 valid, determinate assay result 1 month after vaccination (1 month after second dose of RSVpreF); had no major protocol violations from vaccination through 1-month postvaccination blood draw (1 month after second dose of RSVpreF).
GMT of RSV A and RSV B before vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
SSA: RSVpreF
n=90 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=98 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: GMT of NT for RSV A and RSV B 1 Month After Vaccination 2
RSV A
|
21910 Titer
Interval 17308.8 to 27733.3
|
25159 Titer
Interval 20085.1 to 31515.2
|
|
SSB: GMT of NT for RSV A and RSV B 1 Month After Vaccination 2
RSV B
|
20936 Titer
Interval 16154.0 to 27134.4
|
22774 Titer
Interval 18016.7 to 28788.3
|
SECONDARY outcome
Timeframe: At 1 Month After Vaccination 1 (on Day 1) to 1 Month Post-Vaccination 1Population: Evaluable immunogenicity population included all eligible participants for SSB who received 2 dose of RSVpreF; (blood collected for 1 month after last dose to be 27-42 days after second dose of RSVpreF; had at least 1 valid, determinate assay result 1 month after vaccination (1 month after second dose of RSVpreF); had no major protocol violations from vaccination through 1-month postvaccination blood draw (1 month after second dose of RSVpreF).
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
SSA: RSVpreF
n=90 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=98 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: Geometric Mean Fold Rise (GMFR) of NTs for RSV A and RSV B From Vaccination 1 to 1 Month Post-Vaccination 1
RSV A
|
8.8 Fold rise
Interval 6.76 to 11.53
|
7.9 Fold rise
Interval 6.21 to 10.13
|
|
SSB: Geometric Mean Fold Rise (GMFR) of NTs for RSV A and RSV B From Vaccination 1 to 1 Month Post-Vaccination 1
RSV B
|
9.6 Fold rise
Interval 7.31 to 12.51
|
8.5 Fold rise
Interval 6.7 to 10.75
|
SECONDARY outcome
Timeframe: At 1 Month After Vaccination 1 (on Day 1) to 1 Month Post-Vaccination 2Population: Evaluable immunogenicity population was analyzed.
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
SSA: RSVpreF
n=90 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=98 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSB: GMFR of NTs for RSV A and RSV B From Vaccination 1 to 1 Month Post-Vaccination 2
RSV A
|
7.4 Fold rise
Interval 5.88 to 9.29
|
7.7 Fold rise
Interval 6.11 to 9.58
|
|
SSB: GMFR of NTs for RSV A and RSV B From Vaccination 1 to 1 Month Post-Vaccination 2
RSV B
|
8.1 Fold rise
Interval 6.45 to 10.18
|
7.6 Fold rise
Interval 6.06 to 9.57
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination (on Day 1) and 1 Month After VaccinationPopulation: Evaluable immunogenicity population=participants who met following criteria:(i)eligible for Substudy A;(ii)received study interventions (RSVpreF or placebo)to which they were randomized;(iii)had 1-month postvaccination blood collected 27-42days after vaccination;(iv) had at least 1 valid,determinate assay result 1month after vaccination;(v)had no major protocol violations from vaccination through 1-month postvaccination blood draw. Here,'Number Analyzed'=participants evaluable at specified rows.
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
SSA: RSVpreF
n=437 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=217 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: GMT of NTs for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
RSV A: Before Vaccination
|
2388 Titer
Interval 2207.7 to 2583.3
|
2797 Titer
Interval 2516.8 to 3108.9
|
|
SSA: GMT of NTs for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
RSV A: 1 month after vaccination
|
41595 Titer
Interval 38416.6 to 45037.5
|
2660 Titer
Interval 2395.2 to 2953.9
|
|
SSA: GMT of NTs for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
RSV B: Before Vaccination
|
2075 Titer
Interval 1899.7 to 2265.4
|
2230 Titer
Interval 1988.6 to 2501.6
|
|
SSA: GMT of NTs for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
RSV B: 1 month after vaccination
|
38450 Titer
Interval 35187.5 to 42014.7
|
2135 Titer
Interval 1905.9 to 2391.3
|
SECONDARY outcome
Timeframe: SSA: Before Vaccination (on Day 1) and 1 Month After VaccinationPopulation: Evaluable immunogenicity population=participants who met following criteria:(i)eligible for Substudy A;(ii)received study interventions (RSVpreF or placebo)to which they were randomized;(iii)had 1-month postvaccination blood collected 27-42days after vaccination;(iv) had at least 1 valid,determinate assay result 1month after vaccination;(v)had no major protocol violations from vaccination through 1-month postvaccination blood draw. Here,'Number Analyzed'=participants evaluable at specified rows.
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
SSA: RSVpreF
n=437 Participants
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=217 Participants
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
|---|---|---|
|
SSA: GMFR of NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
RSV A
|
17.5 Fold rise
Interval 15.88 to 19.21
|
1.0 Fold rise
Interval 0.9 to 1.0
|
|
SSA: GMFR of NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
RSV B
|
18.5 Fold rise
Interval 16.76 to 20.43
|
1.0 Fold rise
Interval 0.91 to 1.01
|
Adverse Events
SSA: RSVpreF
Serious events: 5 serious events
Other events: 301 other events
Deaths: 1 deaths
SSA: Placebo
Serious events: 7 serious events
Other events: 135 other events
Deaths: 0 deaths
SSB: RSVpreF, >= 18 to < 60 Years
Serious events: 7 serious events
Other events: 73 other events
Deaths: 0 deaths
SSB: RSVpreF, >= 60 Years
Serious events: 15 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SSA: RSVpreF
n=453 participants at risk
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=225 participants at risk
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
SSB: RSVpreF, >= 18 to < 60 Years
n=96 participants at risk
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
SSB: RSVpreF, >= 60 Years
n=107 participants at risk
Participants aged \>=60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
|---|---|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Cardiac disorders
Tachycardia
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Ear and labyrinth disorders
Vertigo
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Postoperative wound infection
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant glioma
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Paraesthesia
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Psychiatric disorders
Depression
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Psychiatric disorders
Suicidal ideation
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Eye disorders
Visual impairment
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Chest pain
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Immune system disorders
Kidney transplant rejection
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Cystitis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
SARS-CoV-2 sepsis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Haematoma
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
Other adverse events
| Measure |
SSA: RSVpreF
n=453 participants at risk
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly on Day 1 of SSA.
|
SSA: Placebo
n=225 participants at risk
Participants aged \>=18 to \<60 years received placebo (lyophile matched to RSVpreF) intramuscularly on Day 1 of SSA.
|
SSB: RSVpreF, >= 18 to < 60 Years
n=96 participants at risk
Participants aged \>=18 to \<60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
SSB: RSVpreF, >= 60 Years
n=107 participants at risk
Participants aged \>=60 years received RSVpreF 120 mcg intramuscularly first dose on Day 1 of SSB (Vaccination 1) and second dose on 1-month post-vaccination 1 (Vaccination 2).
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Eye disorders
Epiretinal membrane
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Eye disorders
Ocular hypertension
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Eye disorders
Vitreous haemorrhage
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Fatigue (FATIGUE)
|
37.1%
168/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
38.2%
86/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
54.2%
52/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
57.9%
62/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Injection site pain (PAIN AT INJECTION SITE)
|
35.1%
159/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
10.7%
24/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
56.2%
54/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
38.3%
41/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Oedema peripheral
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Pyrexia (FEVER)
|
1.5%
7/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.3%
3/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Swelling (SWELLING)
|
7.1%
32/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.89%
2/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
9.4%
9/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
11.2%
12/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
14.8%
67/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
16.9%
38/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
29.2%
28/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
25.2%
27/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Food poisoning
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Nausea (NAUSEA)
|
11.7%
53/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
10.2%
23/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
15.6%
15/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
12.1%
13/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
2.0%
9/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.3%
3/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
5.2%
5/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.9%
2/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Hepatobiliary disorders
Primary biliary cholangitis
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Immune system disorders
Seasonal allergy
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
COVID-19
|
1.5%
7/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.3%
3/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.9%
2/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Bronchitis
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Campylobacter infection
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Localised infection
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Otitis media
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Sinusitis
|
0.66%
3/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Tinea cruris
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.66%
3/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.89%
2/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
2.1%
2/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
4.7%
5/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.8%
4/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
2.1%
2/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.9%
2/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
3/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
3.7%
4/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Hepatobiliary procedural complication
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Investigations
Weight decreased
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Gout
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.66%
3/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
12.4%
56/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
10.2%
23/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
21.9%
21/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
25.2%
27/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
24.3%
110/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
16.0%
36/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
33.3%
32/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
30.8%
33/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Bell's palsy
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Dizziness
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Headache (HEADACHE)
|
28.3%
128/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
30.2%
68/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
43.8%
42/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
35.5%
38/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Migraine
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
3.1%
3/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Seizure
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Psychiatric disorders
Depression
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.89%
2/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema (REDNESS)
|
6.0%
27/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
7.3%
7/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
7.5%
8/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Social circumstances
Physical assault
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Bleeding varicose vein
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.44%
1/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Hypotension
|
0.22%
1/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.9%
2/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
General disorders
Impaired healing
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Candida infection
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
2.8%
3/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage IV
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Haematoma
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.93%
1/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/453 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/225 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
1.0%
1/96 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
0.00%
0/107 • SSA- LR/SE: Within 7Days after Vaccination (Vacc on Day1);AEs: Within 1 Month (M) after Vacc (Vacc on Day1), including any events reported up to 6 months; SAEs: Any events reported up to 6 months; SSB- LR/SE: Within 7 Days after Vacc1 (Day1 of SSB) Within 7 Days after Vacc 2 (second dose on 1M post-vacc.1); AEs: From Vacc 1 (on Day1) through 1M after Vacc 2 (1M after Vacc1) [approximately up to maximum of 2M], including any events reported up to 7 months; SAEs: any events reported up to 7 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received the study intervention.
|
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