Trial Outcomes & Findings for A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults (NCT NCT05788237)
NCT ID: NCT05788237
Last Updated: 2024-11-22
Results Overview
Local reactions included pain, redness and swelling at the injection site, 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; 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: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
508 participants
Primary outcome timeframe
SSA: From Day 1 to Day 7 after Vaccination 1
Results posted on
2024-11-22
Participant Flow
This study had sub-study A (SSA) and sub-study B (SSB).
A total of 508 participants (SSA: 273 + SSB: 235) were enrolled in this study, 455 participants (SSA:251 + SSB: 204) were randomized to receive study intervention.
Participant milestones
| Measure |
SSA: Group 1: Combination (RSVpreF + qIRV)/ Placebo
Participants aged \>= 60 years were randomized to receive 1.0 mL combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\]. After 1 month, placebo (0.9% normal saline for injection) \[Vaccination 2\] was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2.
|
SSA: Group 2: Sequential Administration qIRV/ RSVpreF
Participants aged \>= 60 years were randomized to receive 1.0 mL of qIRV intramuscularly on Day 1 (Vaccination 1). After 1 month, RSVpreF (Vaccination 2) was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2.
|
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation
Participants aged \>=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination.
|
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Participants aged \>=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination.
|
|---|---|---|---|---|
|
SSA (Approximately 2 Months)
STARTED
|
125
|
126
|
0
|
0
|
|
SSA (Approximately 2 Months)
Vaccination 1
|
125
|
126
|
0
|
0
|
|
SSA (Approximately 2 Months)
Vaccination 2
|
121
|
116
|
0
|
0
|
|
SSA (Approximately 2 Months)
COMPLETED
|
120
|
113
|
0
|
0
|
|
SSA (Approximately 2 Months)
NOT COMPLETED
|
5
|
13
|
0
|
0
|
|
SSB (Approximately 1 Month)
STARTED
|
0
|
0
|
102
|
102
|
|
SSB (Approximately 1 Month)
Vaccination
|
0
|
0
|
101
|
102
|
|
SSB (Approximately 1 Month)
COMPLETED
|
0
|
0
|
101
|
100
|
|
SSB (Approximately 1 Month)
NOT COMPLETED
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
SSA: Group 1: Combination (RSVpreF + qIRV)/ Placebo
Participants aged \>= 60 years were randomized to receive 1.0 mL combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\]. After 1 month, placebo (0.9% normal saline for injection) \[Vaccination 2\] was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2.
|
SSA: Group 2: Sequential Administration qIRV/ RSVpreF
Participants aged \>= 60 years were randomized to receive 1.0 mL of qIRV intramuscularly on Day 1 (Vaccination 1). After 1 month, RSVpreF (Vaccination 2) was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2.
|
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation
Participants aged \>=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination.
|
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Participants aged \>=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination.
|
|---|---|---|---|---|
|
SSA (Approximately 2 Months)
No longer met eligibility criteria
|
0
|
1
|
0
|
0
|
|
SSA (Approximately 2 Months)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
SSA (Approximately 2 Months)
Withdrawal by Subject
|
4
|
8
|
0
|
0
|
|
SSA (Approximately 2 Months)
Adverse Event
|
1
|
2
|
0
|
0
|
|
SSA (Approximately 2 Months)
Death
|
0
|
1
|
0
|
0
|
|
SSB (Approximately 1 Month)
Not Vaccinated
|
0
|
0
|
1
|
0
|
|
SSB (Approximately 1 Month)
Refused further study procedures
|
0
|
0
|
0
|
1
|
|
SSB (Approximately 1 Month)
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults
Baseline characteristics by cohort
| Measure |
SSA: Group 1: Combination (RSVpreF + qIRV)/ Placebo
n=125 Participants
Participants aged \>= 60 years were randomized to receive 1.0 mL combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\]. After 1 month, placebo (0.9% normal saline for injection) \[Vaccination 2\] was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2.
|
SSA: Group 2: Sequential Administration qIRV/ RSVpreF
n=126 Participants
Participants aged \>= 60 years were randomized to receive 1.0 mL of qIRV intramuscularly on Day 1 (Vaccination 1). After 1 month, RSVpreF (Vaccination 2) was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2.
|
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation
n=101 Participants
Participants aged \>=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination.
|
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
n=102 Participants
Participants aged \>=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination.
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
50-64 years
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Age, Customized
65-79 years
|
94 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
282 Participants
n=21 Participants
|
|
Age, Customized
>=80 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
125 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
453 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
454 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: SSA: From Day 1 to Day 7 after Vaccination 1Population: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.
Local reactions included pain, redness and swelling at the injection site, 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; 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: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=125 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=125 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Mild
|
49.6 Percentage of participants
Interval 40.5 to 58.7
|
52.0 Percentage of participants
Interval 42.9 to 61.0
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Moderate
|
20.8 Percentage of participants
Interval 14.1 to 29.0
|
28.0 Percentage of participants
Interval 20.3 to 36.7
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
2.4 Percentage of participants
Interval 0.5 to 6.9
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Mild
|
3.2 Percentage of participants
Interval 0.9 to 8.0
|
3.2 Percentage of participants
Interval 0.9 to 8.0
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Moderate
|
4.0 Percentage of participants
Interval 1.3 to 9.1
|
4.8 Percentage of participants
Interval 1.8 to 10.2
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0.8 Percentage of participants
Interval 0.0 to 4.4
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Mild
|
5.6 Percentage of participants
Interval 2.3 to 11.2
|
6.4 Percentage of participants
Interval 2.8 to 12.2
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Moderate
|
3.2 Percentage of participants
Interval 0.9 to 8.0
|
8.0 Percentage of participants
Interval 3.9 to 14.2
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Severe
|
0.8 Percentage of participants
Interval 0.0 to 4.4
|
2.4 Percentage of participants
Interval 0.5 to 6.9
|
PRIMARY outcome
Timeframe: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1)Population: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; 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: 2.5 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm; severe: \> 10 cm.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=121 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=115 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Moderate
|
1.7 Percentage of participants
Interval 0.2 to 5.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Mild
|
1.7 Percentage of participants
Interval 0.2 to 5.8
|
7.8 Percentage of participants
Interval 3.6 to 14.3
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Mild
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Mild
|
0.8 Percentage of participants
Interval 0.0 to 4.5
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
PRIMARY outcome
Timeframe: SSB: From Day 1 to Day 7 after VaccinationPopulation: SSB: E-diary safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL) and with at least 1 day of e-diary data transferred.
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; 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: 2.5 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm; severe: \> 10 cm.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=101 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=102 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Mild
|
4.0 Percentage of participants
Interval 1.1 to 9.8
|
5.9 Percentage of participants
Interval 2.2 to 12.4
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Mild
|
42.6 Percentage of participants
Interval 32.8 to 52.8
|
43.1 Percentage of participants
Interval 33.4 to 53.3
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Moderate
|
31.7 Percentage of participants
Interval 22.8 to 41.7
|
32.4 Percentage of participants
Interval 23.4 to 42.3
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Severe
|
1.0 Percentage of participants
Interval 0.0 to 5.4
|
2.9 Percentage of participants
Interval 0.6 to 8.4
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Mild
|
2.0 Percentage of participants
Interval 0.2 to 7.0
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.6
|
3.9 Percentage of participants
Interval 1.1 to 9.7
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.6
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Moderate
|
5.9 Percentage of participants
Interval 2.2 to 12.5
|
7.8 Percentage of participants
Interval 3.4 to 14.9
|
|
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.6
|
PRIMARY outcome
Timeframe: SSA: From Day 1 to Day 7 after Vaccination 1Population: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened 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, 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, chills, new/worsened muscle pain and new/worsened 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: Group 1: RSVpreF + qIRV
n=125 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=125 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Mild
|
1.6 Percentage of participants
Interval 0.2 to 5.7
|
1.6 Percentage of participants
Interval 0.2 to 5.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: Mild
|
4.0 Percentage of participants
Interval 1.3 to 9.1
|
12.8 Percentage of participants
Interval 7.5 to 20.0
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: Moderate
|
6.4 Percentage of participants
Interval 2.8 to 12.2
|
4.0 Percentage of participants
Interval 1.3 to 9.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: Severe
|
1.6 Percentage of participants
Interval 0.2 to 5.7
|
5.6 Percentage of participants
Interval 2.3 to 11.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Mild
|
20.8 Percentage of participants
Interval 14.1 to 29.0
|
20.8 Percentage of participants
Interval 14.1 to 29.0
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Moderate
|
30.4 Percentage of participants
Interval 22.5 to 39.3
|
24.0 Percentage of participants
Interval 16.8 to 32.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Severe
|
0.8 Percentage of participants
Interval 0.0 to 4.4
|
4.0 Percentage of participants
Interval 1.3 to 9.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Mild
|
24.0 Percentage of participants
Interval 16.8 to 32.5
|
26.4 Percentage of participants
Interval 18.9 to 35.0
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Moderate
|
24.8 Percentage of participants
Interval 17.5 to 33.3
|
11.2 Percentage of participants
Interval 6.3 to 18.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 2.9
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 2.9
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 2.9
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Nausea: Mild
|
5.6 Percentage of participants
Interval 2.3 to 11.2
|
5.6 Percentage of participants
Interval 2.3 to 11.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Nausea: Moderate
|
2.4 Percentage of participants
Interval 0.5 to 6.9
|
3.2 Percentage of participants
Interval 0.9 to 8.0
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Nausea: Severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 2.9
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Mild
|
4.8 Percentage of participants
Interval 1.8 to 10.2
|
4.0 Percentage of participants
Interval 1.3 to 9.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Moderate
|
1.6 Percentage of participants
Interval 0.2 to 5.7
|
1.6 Percentage of participants
Interval 0.2 to 5.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Severe
|
0.8 Percentage of participants
Interval 0.0 to 4.4
|
0 Percentage of participants
Interval 0.0 to 2.9
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Mild
|
15.2 Percentage of participants
Interval 9.4 to 22.7
|
20.8 Percentage of participants
Interval 14.1 to 29.0
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Moderate
|
12.0 Percentage of participants
Interval 6.9 to 19.0
|
11.2 Percentage of participants
Interval 6.3 to 18.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 2.9
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Mild
|
17.6 Percentage of participants
Interval 11.4 to 25.4
|
20.8 Percentage of participants
Interval 14.1 to 29.0
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Moderate
|
22.4 Percentage of participants
Interval 15.4 to 30.7
|
15.2 Percentage of participants
Interval 9.4 to 22.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
1.6 Percentage of participants
Interval 0.2 to 5.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Mild
|
11.2 Percentage of participants
Interval 6.3 to 18.1
|
11.2 Percentage of participants
Interval 6.3 to 18.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Moderate
|
14.4 Percentage of participants
Interval 8.8 to 21.8
|
6.4 Percentage of participants
Interval 2.8 to 12.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0.8 Percentage of participants
Interval 0.0 to 4.4
|
PRIMARY outcome
Timeframe: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1)Population: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 deg C and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: \>2 times in 24h; severe: required 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, chills, new/worsened muscle pain and new/worsened 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: Group 1: RSVpreF + qIRV
n=121 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=115 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Nausea: Mild
|
3.3 Percentage of participants
Interval 0.9 to 8.2
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Mild
|
5.8 Percentage of participants
Interval 2.4 to 11.6
|
4.3 Percentage of participants
Interval 1.4 to 9.9
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: Mild
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Mild
|
7.4 Percentage of participants
Interval 3.5 to 13.7
|
6.1 Percentage of participants
Interval 2.5 to 12.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Moderate
|
3.3 Percentage of participants
Interval 0.9 to 8.2
|
7.0 Percentage of participants
Interval 3.1 to 13.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Mild
|
10.7 Percentage of participants
Interval 5.8 to 17.7
|
10.4 Percentage of participants
Interval 5.5 to 17.5
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Moderate
|
5.8 Percentage of participants
Interval 2.4 to 11.6
|
6.1 Percentage of participants
Interval 2.5 to 12.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Nausea: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Nausea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Mild
|
5.0 Percentage of participants
Interval 1.8 to 10.5
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Moderate
|
1.7 Percentage of participants
Interval 0.2 to 5.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Mild
|
2.5 Percentage of participants
Interval 0.5 to 7.1
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Moderate
|
1.7 Percentage of participants
Interval 0.2 to 5.8
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Moderate
|
1.7 Percentage of participants
Interval 0.2 to 5.8
|
7.0 Percentage of participants
Interval 3.1 to 13.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Mild
|
4.1 Percentage of participants
Interval 1.4 to 9.4
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Moderate
|
1.7 Percentage of participants
Interval 0.2 to 5.8
|
6.1 Percentage of participants
Interval 2.5 to 12.1
|
|
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.0
|
0 Percentage of participants
Interval 0.0 to 3.2
|
PRIMARY outcome
Timeframe: SSB: From Day 1 to Day 7 After VaccinationPopulation: SSB: E-diary safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL) and with at least 1 day of e-diary data transferred.
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 deg C and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: \>2 times in 24h; severe: required 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, chills, new/worsened muscle pain and new/worsened 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: Group 1: RSVpreF + qIRV
n=101 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=102 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Mild
|
15.8 Percentage of participants
Interval 9.3 to 24.4
|
10.8 Percentage of participants
Interval 5.5 to 18.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Moderate
|
4.0 Percentage of participants
Interval 1.1 to 9.8
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Severe
|
2.0 Percentage of participants
Interval 0.2 to 7.0
|
0 Percentage of participants
Interval 0.0 to 3.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Mild
|
20.8 Percentage of participants
Interval 13.4 to 30.0
|
28.4 Percentage of participants
Interval 19.9 to 38.2
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate
|
36.6 Percentage of participants
Interval 27.3 to 46.8
|
26.5 Percentage of participants
Interval 18.2 to 36.1
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
5.9 Percentage of participants
Interval 2.2 to 12.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Mild
|
18.8 Percentage of participants
Interval 11.7 to 27.8
|
26.5 Percentage of participants
Interval 18.2 to 36.1
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Moderate
|
27.7 Percentage of participants
Interval 19.3 to 37.5
|
15.7 Percentage of participants
Interval 9.2 to 24.2
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 3.6
|
2.0 Percentage of participants
Interval 0.2 to 6.9
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 3.6
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Mild
|
5.0 Percentage of participants
Interval 1.6 to 11.2
|
11.8 Percentage of participants
Interval 6.2 to 19.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Moderate
|
4.0 Percentage of participants
Interval 1.1 to 9.8
|
2.9 Percentage of participants
Interval 0.6 to 8.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Mild
|
9.9 Percentage of participants
Interval 4.9 to 17.5
|
10.8 Percentage of participants
Interval 5.5 to 18.5
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Moderate
|
5.9 Percentage of participants
Interval 2.2 to 12.5
|
2.9 Percentage of participants
Interval 0.6 to 8.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
0 Percentage of participants
Interval 0.0 to 3.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Chills: Mild
|
15.8 Percentage of participants
Interval 9.3 to 24.4
|
17.6 Percentage of participants
Interval 10.8 to 26.4
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Chills: Moderate
|
24.8 Percentage of participants
Interval 16.7 to 34.3
|
13.7 Percentage of participants
Interval 7.7 to 22.0
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
New or worsened muscle pain: Mild
|
18.8 Percentage of participants
Interval 11.7 to 27.8
|
21.6 Percentage of participants
Interval 14.0 to 30.8
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
New or worsened muscle pain: Moderate
|
27.7 Percentage of participants
Interval 19.3 to 37.5
|
22.5 Percentage of participants
Interval 14.9 to 31.9
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
New or worsened muscle pain: Severe
|
2.0 Percentage of participants
Interval 0.2 to 7.0
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
New or worsened joint pain: Mild
|
14.9 Percentage of participants
Interval 8.6 to 23.3
|
11.8 Percentage of participants
Interval 6.2 to 19.6
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
New or worsened joint pain: Moderate
|
20.8 Percentage of participants
Interval 13.4 to 30.0
|
16.7 Percentage of participants
Interval 10.0 to 25.3
|
|
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 3.6
|
1.0 Percentage of participants
Interval 0.0 to 5.3
|
PRIMARY outcome
Timeframe: SSA: Within 1 Month after Vaccination 1Population: SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone.
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.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=125 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=126 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
|
29.6 Percentage of participants
Interval 21.8 to 38.4
|
33.3 Percentage of participants
Interval 25.2 to 42.3
|
PRIMARY outcome
Timeframe: SSA: Within 1 Month after Vaccination 2Population: SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone.
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.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=121 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=116 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2
|
16.5 Percentage of participants
Interval 10.4 to 24.4
|
13.8 Percentage of participants
Interval 8.1 to 21.4
|
PRIMARY outcome
Timeframe: SSB: From Day 1 of Vaccination up to 35 days of follow-up post VaccinationPopulation: SSB: Safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL).
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. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=101 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=102 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSB: Percentage of Participants Reporting AEs Throughout the Sub Study
|
22.8 Percentage of participants
Interval 15.0 to 32.2
|
33.3 Percentage of participants
Interval 24.3 to 43.4
|
PRIMARY outcome
Timeframe: SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days)Population: SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone.
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.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=125 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=126 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study
|
0 Percentage of participants
Interval 0.0 to 2.9
|
2.4 Percentage of participants
Interval 0.5 to 6.8
|
PRIMARY outcome
Timeframe: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days)Population: SSB: Safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL).
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.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=101 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=102 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study
|
2.0 Percentage of participants
Interval 0.2 to 7.0
|
0 Percentage of participants
Interval 0.0 to 3.6
|
PRIMARY outcome
Timeframe: SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)Population: Evaluable RSV immunogenicity population: all eligible participants who received the study intervention to which they were randomized, had the 1 month postvaccination blood collection within 27 to 42 days after vaccination, had at least 1 valid and determinate RSV NT result at the 1-month postvaccination blood collection, and had no major protocol violations from randomization through the 1 month postvaccination blood collection.
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV subgroup A (RSV A) or RSV subgroup B (RSV B) neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=119 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=112 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2)
NT: RSV A
|
16553 Titer
Interval 14120.9 to 19403.1
|
19740 Titer
Interval 16555.5 to 23536.4
|
|
SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2)
NT: RSV B
|
11795 Titer
Interval 9961.1 to 13966.7
|
14959 Titer
Interval 12408.8 to 18032.4
|
PRIMARY outcome
Timeframe: SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)Population: Evaluable HAI immunogenicity population: all eligible participants who received the study intervention to which they were randomized, and had the 1month postvaccination blood collection for HAI assay within 27-42 days after vaccination, had at least 1 valid and determinate HAI result at 1 month postvaccination blood collection, had no major protocol violations from randomization through 1 month postvaccination blood collection.
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group. The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=119 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=112 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2)
HAI: H1N1 A/Wisconsin
|
194 Titer
Interval 164.3 to 227.9
|
238 Titer
Interval 196.5 to 288.7
|
|
SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2)
HAI: H3N2 A/Darwin
|
161 Titer
Interval 136.9 to 189.9
|
219 Titer
Interval 178.1 to 269.0
|
|
SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2)
HAI: B/Austria
|
53 Titer
Interval 44.6 to 62.1
|
56 Titer
Interval 47.7 to 66.3
|
|
SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2)
HAI: B/Phuket
|
22 Titer
Interval 18.5 to 26.4
|
24 Titer
Interval 20.2 to 29.1
|
SECONDARY outcome
Timeframe: SSB: At 1 Month after Vaccination (Day 1)Population: Evaluable RSV immunogenicity population: all eligible participants who received the study intervention to which they were randomized, had the 1-month postvaccination blood collection within 27 to 42 days after vaccination, had at least 1 valid and determinate RSV NT result at the 1 month postvaccination blood collection, and had no major protocol violations from randomization through the 1 month postvaccination blood collection.
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV A or RSV B neutralizing GMTs in the combination of 1 mL RSVpreF + qIRV (group 1) and 0.5 ml of RSVpreF + qIRV (group 2)
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=100 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=99 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination
NT: RSV A
|
32044 Titer
Interval 26676.5 to 38492.2
|
30575 Titer
Interval 25922.1 to 36062.4
|
|
SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination
NT: RSV B
|
30364 Titer
Interval 25533.4 to 36108.2
|
28614 Titer
Interval 24113.5 to 33954.8
|
SECONDARY outcome
Timeframe: SSB: At 1 Month after Vaccination (Day 1)Population: Evaluable HAI immunogenicity population: all eligible participants who received the study intervention to which they were randomized, and had the 1month postvaccination blood collection for HAI assay within 27-42 days after vaccination,had atleast 1 valid and determinate HAI result at 1 month postvaccination blood collection,had no major protocol violations from randomization through 1 month postvaccination blood collection. 'Number Analyzed'=participants evaluable for specified rows.
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs to the combination of 1 mL RSVpreF + qIRV (Group 1) and 0.5 ml of RSVpreF + qIRV (Group 2). The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket.
Outcome measures
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=100 Participants
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: qIRV
n=99 Participants
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
|---|---|---|
|
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
HAI: H1N1 A/Sydney
|
257 Titer
Interval 212.6 to 311.8
|
217 Titer
Interval 170.2 to 275.8
|
|
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
HAI: H3N2 A/Darwin
|
259 Titer
Interval 216.4 to 310.8
|
229 Titer
Interval 188.7 to 279.0
|
|
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
HAI: B/Austria
|
58 Titer
Interval 49.0 to 69.0
|
54 Titer
Interval 45.0 to 64.1
|
|
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
HAI: B/Phuket
|
32 Titer
Interval 27.0 to 38.6
|
29 Titer
Interval 25.1 to 34.4
|
Adverse Events
SSA: Group 1: RSVpreF + qIRV
Serious events: 0 serious events
Other events: 117 other events
Deaths: 0 deaths
SSA: Group 1: Placebo
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
SSA: Group 2: qIRV
Serious events: 1 serious events
Other events: 117 other events
Deaths: 0 deaths
SSA: Group 2: RSVpreF
Serious events: 1 serious events
Other events: 43 other events
Deaths: 1 deaths
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation
Serious events: 2 serious events
Other events: 91 other events
Deaths: 0 deaths
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=125 participants at risk
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 1: Placebo
n=121 participants at risk
Participants received placebo intramuscularly on 1 month after Vaccination 1 \[Vaccination 2\].
|
SSA: Group 2: qIRV
n=126 participants at risk
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: RSVpreF
n=116 participants at risk
Participants received 1 mL of RSVpreF intramuscularly on 1 month after Vaccination 1 \[Vaccination 2\].
|
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation
n=101 participants at risk
Participants aged \>=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1.
|
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
n=102 participants at risk
Participants aged \>=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Syncope
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
Other adverse events
| Measure |
SSA: Group 1: RSVpreF + qIRV
n=125 participants at risk
Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 1: Placebo
n=121 participants at risk
Participants received placebo intramuscularly on 1 month after Vaccination 1 \[Vaccination 2\].
|
SSA: Group 2: qIRV
n=126 participants at risk
Participants received 1 mL of qIRV intramuscularly on Day 1 \[Vaccination 1\].
|
SSA: Group 2: RSVpreF
n=116 participants at risk
Participants received 1 mL of RSVpreF intramuscularly on 1 month after Vaccination 1 \[Vaccination 2\].
|
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation
n=101 participants at risk
Participants aged \>=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1.
|
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
n=102 participants at risk
Participants aged \>=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Cardiac disorders
Cardiac septal hypertrophy
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Cardiac disorders
Left atrial dilatation
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Axillary pain
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Chest pain
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.0%
2/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.9%
3/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Influenza like illness
|
1.6%
2/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.5%
3/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
1.6%
2/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.0%
2/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
8.8%
9/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Injection site bruising
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Injection site erythema
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Injection site lymphadenopathy
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Injection site pruritus
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Pyrexia
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Vaccination site papule
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Odynophagia
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Bronchitis
|
3.2%
4/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.0%
2/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.0%
2/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Localised infection
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Oral candidiasis
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.0%
2/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
1.7%
2/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Tooth infection
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Infections and infestations
Urinary tract infection
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Injury, poisoning and procedural complications
Buttock injury
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
2/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Investigations
Troponin T increased
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
1.7%
2/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.4%
3/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.4%
3/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Headache
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Syncope
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Tension headache
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.80%
1/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
12.0%
15/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
5.0%
6/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
10.3%
13/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
3.4%
4/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
4.0%
4/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
11.8%
12/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.79%
1/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.98%
1/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
1.6%
2/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
1.6%
2/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.99%
1/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Vascular disorders
Haematoma
|
0.00%
0/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.86%
1/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Vascular disorders
Hypertension
|
1.6%
2/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
4.8%
6/126 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/116 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.0%
2/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.0%
2/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Chills (CHILLS)
|
27.2%
34/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
4.1%
5/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
32.0%
40/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
6.1%
7/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
40.6%
41/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
32.4%
33/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Fatigue (FATIGUE)
|
52.0%
65/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
10.7%
13/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
48.8%
61/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
14.8%
17/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
57.4%
58/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
60.8%
62/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Injection site erythema (REDNESS)
|
7.2%
9/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
8.8%
11/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.0%
2/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
5.9%
6/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Injection site pain (PAIN AT THE INJECTION SITE)
|
70.4%
88/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
3.3%
4/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
82.4%
103/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
8.7%
10/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
75.2%
76/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
78.4%
80/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Injection site swelling (SWELLING)
|
9.6%
12/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.83%
1/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
16.8%
21/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.87%
1/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
9.9%
10/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
13.7%
14/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
General disorders
Pyrexia (FEVER)
|
12.0%
15/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
22.4%
28/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.6%
3/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
21.8%
22/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
12.7%
13/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
7.2%
9/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
6.6%
8/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
5.6%
7/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
3.5%
4/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
15.8%
16/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
13.7%
14/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Nausea (NAUSEA)
|
8.0%
10/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
3.3%
4/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
8.8%
11/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
1.7%
2/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
8.9%
9/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
14.7%
15/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
1.6%
2/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
1.6%
2/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
0.00%
0/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
2.9%
3/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (NEW OR WORSENED JOINT PAIN)
|
25.6%
32/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
5.8%
7/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
18.4%
23/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
8.7%
10/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
35.6%
36/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
29.4%
30/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (NEW OR WORSENED MUSCLE PAIN)
|
40.0%
50/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
7.4%
9/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
37.6%
47/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
11.3%
13/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
48.5%
49/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
45.1%
46/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
|
Nervous system disorders
Headache (HEADACHE)
|
48.8%
61/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
16.5%
20/121 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
37.6%
47/125 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
17.4%
20/115 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
46.5%
47/101 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
|
44.1%
45/102 • Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
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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 publication 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