Trial Outcomes & Findings for A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN (NCT NCT04032093)
NCT ID: NCT04032093
Last Updated: 2022-10-18
Results Overview
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1153 participants
Primary outcome timeframe
Within 7 days after vaccination
Results posted on
2022-10-18
Participant Flow
Pregnant maternal participants between 18 to 49 years of age and infants who were born to these maternal participants were enrolled in this study.
778 maternal participants signed the informed consent form (ICF). 197 participants were screen failures who did not meet criteria and were not enrolled. 581 maternal participants and 572 infants born to maternal participants were randomized into the study.
Participant milestones
| Measure |
Maternal Participants: RSVpreF 120 mcg
Maternal participants received a single dose of 0.5 milliliter (mL) as intramuscular injection of Respiratory Syncytial Virus prefusion F (RSVpreF) vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
Infant Participants: RSVpreF 120 mcg
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: Placebo
Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
116
|
117
|
116
|
115
|
117
|
114
|
117
|
113
|
112
|
116
|
|
Overall Study
Safety Set
|
115
|
117
|
116
|
114
|
117
|
114
|
117
|
113
|
112
|
116
|
|
Overall Study
COMPLETED
|
107
|
107
|
108
|
100
|
99
|
106
|
107
|
108
|
100
|
98
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
8
|
15
|
18
|
8
|
10
|
5
|
12
|
18
|
Reasons for withdrawal
| Measure |
Maternal Participants: RSVpreF 120 mcg
Maternal participants received a single dose of 0.5 milliliter (mL) as intramuscular injection of Respiratory Syncytial Virus prefusion F (RSVpreF) vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
Infant Participants: RSVpreF 120 mcg
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: Placebo
Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
6
|
10
|
13
|
7
|
7
|
5
|
9
|
12
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
2
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
Baseline characteristics by cohort
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=115 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
Infant Participants: RSVpreF 120 mcg
n=114 Participants
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 Participants
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg
n=113 Participants
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=112 Participants
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: Placebo
n=116 Participants
Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Total
n=1151 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Less than or equal to(<=) 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
114 Participants
n=8 Participants
|
117 Participants
n=8 Participants
|
113 Participants
n=24 Participants
|
112 Participants
n=42 Participants
|
116 Participants
n=42 Participants
|
572 Participants
n=42 Participants
|
|
Age, Customized
Greater than or equal to (>=)18 and <= 49 years
|
115 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
579 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
58 Participants
n=24 Participants
|
55 Participants
n=42 Participants
|
53 Participants
n=42 Participants
|
865 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
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
|
52 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
55 Participants
n=24 Participants
|
57 Participants
n=42 Participants
|
63 Participants
n=42 Participants
|
286 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
323 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
81 Participants
n=8 Participants
|
79 Participants
n=8 Participants
|
84 Participants
n=24 Participants
|
79 Participants
n=42 Participants
|
81 Participants
n=42 Participants
|
822 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
237 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
79 Participants
n=8 Participants
|
86 Participants
n=8 Participants
|
82 Participants
n=24 Participants
|
84 Participants
n=42 Participants
|
89 Participants
n=42 Participants
|
859 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=115 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Redness: Mild
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
5.2 Percentage of participants
Interval 1.9 to 10.9
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Redness: Moderate
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
2.6 Percentage of participants
Interval 0.5 to 7.5
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 3.2
|
0 Percentage of participants
Interval 0.0 to 3.2
|
0 Percentage of participants
Interval 0.0 to 3.1
|
0 Percentage of participants
Interval 0.0 to 3.2
|
0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Swelling: Mild
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
4.3 Percentage of participants
Interval 1.4 to 9.8
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Swelling: Moderate
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Swelling: Severe
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Pain at injection site: Mild
|
22.8 Percentage of participants
Interval 15.5 to 31.6
|
53.0 Percentage of participants
Interval 43.5 to 62.4
|
28.4 Percentage of participants
Interval 20.5 to 37.6
|
47.4 Percentage of participants
Interval 37.9 to 56.9
|
12.8 Percentage of participants
Interval 7.4 to 20.3
|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Pain at injection site: Moderate
|
6.1 Percentage of participants
Interval 2.5 to 12.2
|
15.7 Percentage of participants
Interval 9.5 to 23.6
|
5.2 Percentage of participants
Interval 1.9 to 10.9
|
13.2 Percentage of participants
Interval 7.6 to 20.8
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Pain at injection site: Severe
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (\>=38.0 to 38.4 degrees \[deg\] Celsius \[C\]), grade 2: moderate (\>38.4 to 38.9 deg C), grade 3: severe (\>38.9 to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=115 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Fatigue: Severe
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
1.8 Percentage of participants
Interval 0.2 to 6.2
|
1.7 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Fever: Grade 1
|
2.6 Percentage of participants
Interval 0.5 to 7.5
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Fever: Grade 2
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Fever: Grade 3
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Fever: Grade 4
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Fatigue: Mild
|
22.8 Percentage of participants
Interval 15.5 to 31.6
|
27.0 Percentage of participants
Interval 19.1 to 36.0
|
23.3 Percentage of participants
Interval 15.9 to 32.0
|
25.4 Percentage of participants
Interval 17.7 to 34.4
|
24.8 Percentage of participants
Interval 17.3 to 33.6
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Fatigue: Moderate
|
24.6 Percentage of participants
Interval 17.0 to 33.5
|
17.4 Percentage of participants
Interval 11.0 to 25.6
|
19.8 Percentage of participants
Interval 13.0 to 28.3
|
23.7 Percentage of participants
Interval 16.2 to 32.6
|
20.5 Percentage of participants
Interval 13.6 to 29.0
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Headache: Mild
|
18.4 Percentage of participants
Interval 11.8 to 26.8
|
19.1 Percentage of participants
Interval 12.4 to 27.5
|
25.0 Percentage of participants
Interval 17.4 to 33.9
|
18.4 Percentage of participants
Interval 11.8 to 26.8
|
14.5 Percentage of participants
Interval 8.7 to 22.2
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Headache: Moderate
|
10.5 Percentage of participants
Interval 5.6 to 17.7
|
16.5 Percentage of participants
Interval 10.3 to 24.6
|
12.1 Percentage of participants
Interval 6.8 to 19.4
|
10.5 Percentage of participants
Interval 5.6 to 17.7
|
9.4 Percentage of participants
Interval 4.8 to 16.2
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Headache: Severe
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
1.7 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Nausea: Mild
|
14.9 Percentage of participants
Interval 8.9 to 22.8
|
17.4 Percentage of participants
Interval 11.0 to 25.6
|
16.4 Percentage of participants
Interval 10.2 to 24.4
|
14.9 Percentage of participants
Interval 8.9 to 22.8
|
16.2 Percentage of participants
Interval 10.1 to 24.2
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Nausea: Moderate
|
16.7 Percentage of participants
Interval 10.3 to 24.8
|
8.7 Percentage of participants
Interval 4.2 to 15.4
|
8.6 Percentage of participants
Interval 4.2 to 15.3
|
4.4 Percentage of participants
Interval 1.4 to 9.9
|
6.0 Percentage of participants
Interval 2.4 to 11.9
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Nausea: Severe
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Muscle pain: Mild
|
14.9 Percentage of participants
Interval 8.9 to 22.8
|
28.7 Percentage of participants
Interval 20.6 to 37.9
|
21.6 Percentage of participants
Interval 14.5 to 30.1
|
21.9 Percentage of participants
Interval 14.7 to 30.6
|
6.8 Percentage of participants
Interval 3.0 to 13.0
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Muscle pain: Moderate
|
11.4 Percentage of participants
Interval 6.2 to 18.7
|
14.8 Percentage of participants
Interval 8.9 to 22.6
|
12.1 Percentage of participants
Interval 6.8 to 19.4
|
14.0 Percentage of participants
Interval 8.2 to 21.8
|
5.1 Percentage of participants
Interval 1.9 to 10.8
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Muscle pain: Severe
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Joint pain: Mild
|
4.4 Percentage of participants
Interval 1.4 to 9.9
|
7.8 Percentage of participants
Interval 3.6 to 14.3
|
11.2 Percentage of participants
Interval 6.1 to 18.4
|
7.0 Percentage of participants
Interval 3.1 to 13.4
|
5.1 Percentage of participants
Interval 1.9 to 10.8
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Joint pain: Moderate
|
9.6 Percentage of participants
Interval 4.9 to 16.6
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
9.5 Percentage of participants
Interval 4.8 to 16.3
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
4.3 Percentage of participants
Interval 1.4 to 9.7
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Joint pain: Severe
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Vomiting: Mild
|
11.4 Percentage of participants
Interval 6.2 to 18.7
|
7.8 Percentage of participants
Interval 3.6 to 14.3
|
5.2 Percentage of participants
Interval 1.9 to 10.9
|
4.4 Percentage of participants
Interval 1.4 to 9.9
|
6.0 Percentage of participants
Interval 2.4 to 11.9
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Vomiting: Moderate
|
5.3 Percentage of participants
Interval 2.0 to 11.1
|
5.2 Percentage of participants
Interval 1.9 to 11.0
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
1.7 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Vomiting: Severe
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Diarrhea: Mild
|
9.6 Percentage of participants
Interval 4.9 to 16.6
|
10.4 Percentage of participants
Interval 5.5 to 17.5
|
9.5 Percentage of participants
Interval 4.8 to 16.3
|
7.0 Percentage of participants
Interval 3.1 to 13.4
|
12.0 Percentage of participants
Interval 6.7 to 19.3
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Diarrhea: Moderate
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
1.7 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Diarrhea: Severe
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
PRIMARY outcome
Timeframe: Within 1 month after vaccinationPopulation: Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=115 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination
|
22.6 Percentage of participants
Interval 15.3 to 31.3
|
23.9 Percentage of participants
Interval 16.5 to 32.7
|
30.2 Percentage of participants
Interval 22.0 to 39.4
|
22.8 Percentage of participants
Interval 15.5 to 31.6
|
24.8 Percentage of participants
Interval 17.3 to 33.6
|
PRIMARY outcome
Timeframe: From day of vaccination (Day 1) up to 12 months post-deliveryPopulation: Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received.
MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=115 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
MAE
|
20.0 Percentage of participants
Interval 13.1 to 28.5
|
18.8 Percentage of participants
Interval 12.2 to 27.1
|
15.5 Percentage of participants
Interval 9.5 to 23.4
|
21.1 Percentage of participants
Interval 14.0 to 29.7
|
17.1 Percentage of participants
Interval 10.8 to 25.2
|
|
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
SAE
|
6.1 Percentage of participants
Interval 2.5 to 12.1
|
12.8 Percentage of participants
Interval 7.4 to 20.3
|
12.9 Percentage of participants
Interval 7.4 to 20.4
|
16.7 Percentage of participants
Interval 10.3 to 24.8
|
12.0 Percentage of participants
Interval 6.7 to 19.3
|
|
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
Obstetric complications
|
23.5 Percentage of participants
Interval 16.1 to 32.3
|
28.2 Percentage of participants
Interval 20.3 to 37.3
|
30.2 Percentage of participants
Interval 22.0 to 39.4
|
33.3 Percentage of participants
Interval 24.8 to 42.8
|
32.5 Percentage of participants
Interval 24.1 to 41.8
|
PRIMARY outcome
Timeframe: At birthPopulation: Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.
Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=113 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=112 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Percentage of Infant Participants With Specific Birth Complications
|
7.9 Percentage of participants
Interval 3.7 to 14.5
|
10.3 Percentage of participants
Interval 5.4 to 17.2
|
8.8 Percentage of participants
Interval 4.3 to 15.7
|
8.0 Percentage of participants
Interval 3.7 to 14.7
|
9.5 Percentage of participants
Interval 4.8 to 16.3
|
PRIMARY outcome
Timeframe: Within 1 month after birthPopulation: Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=113 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=112 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Percentage of Infant Participants With Any AE Within 1 Month of Age
|
50.9 Percentage of participants
Interval 41.3 to 60.4
|
47.0 Percentage of participants
Interval 37.7 to 56.5
|
46.9 Percentage of participants
Interval 37.5 to 56.5
|
49.1 Percentage of participants
Interval 39.5 to 58.7
|
50.9 Percentage of participants
Interval 41.4 to 60.3
|
PRIMARY outcome
Timeframe: Within 12 months after birthPopulation: Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.
MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=113 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=112 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age
MAE
|
22.8 Percentage of participants
Interval 15.5 to 31.6
|
29.9 Percentage of participants
Interval 21.8 to 39.1
|
30.1 Percentage of participants
Interval 21.8 to 39.4
|
38.4 Percentage of participants
Interval 29.4 to 48.1
|
31.9 Percentage of participants
Interval 23.6 to 41.2
|
|
Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age
SAE
|
36.0 Percentage of participants
Interval 27.2 to 45.5
|
33.3 Percentage of participants
Interval 24.9 to 42.6
|
31.0 Percentage of participants
Interval 22.6 to 40.4
|
39.3 Percentage of participants
Interval 30.2 to 49.0
|
32.8 Percentage of participants
Interval 24.3 to 42.1
|
PRIMARY outcome
Timeframe: Within 12 months after birthPopulation: Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.
AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=114 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=113 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=112 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=116 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay
Congenital Anomalies
|
9.6 Percentage of participants
Interval 4.9 to 16.6
|
4.3 Percentage of participants
Interval 1.4 to 9.7
|
1.8 Percentage of participants
Interval 0.2 to 6.2
|
1.8 Percentage of participants
Interval 0.2 to 6.3
|
6.0 Percentage of participants
Interval 2.5 to 12.0
|
|
Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay
Developmental Delay
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Before vaccination, 2 weeks and 1 month after vaccination and at deliveryPopulation: Maternal evaluable immunogenicity population: eligible maternal participants who received randomized vaccine, had blood collection within protocol-specified time points, had at least 1 valid and determinate assay result after vaccination and had no other major protocol deviations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. Geometric mean ratios (GMRs) of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=111 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=112 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=112 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=110 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=115 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
A 50%: Before vaccination
|
1574 Titer
Interval 1369.2 to 1808.7
|
1577 Titer
Interval 1343.2 to 1850.9
|
1432 Titer
Interval 1221.3 to 1678.2
|
1521 Titer
Interval 1318.6 to 1754.4
|
1450 Titer
Interval 1263.5 to 1663.3
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
A 50%: 2 Weeks after vaccination
|
31871 Titer
Interval 27687.5 to 36685.8
|
31644 Titer
Interval 25759.8 to 38873.3
|
33532 Titer
Interval 28298.3 to 39733.8
|
39874 Titer
Interval 33992.0 to 46773.6
|
1597 Titer
Interval 1357.6 to 1879.4
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
A 50%: 1 Month after vaccination
|
24149 Titer
Interval 19744.0 to 29537.1
|
31007 Titer
Interval 26875.8 to 35773.7
|
23692 Titer
Interval 19234.9 to 29182.2
|
28106 Titer
Interval 24409.9 to 32362.2
|
1549 Titer
Interval 1294.9 to 1853.7
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
A 50%: At delivery
|
12914 Titer
Interval 10781.2 to 15469.2
|
17259 Titer
Interval 14982.9 to 19881.3
|
12231 Titer
Interval 9925.5 to 15071.8
|
15814 Titer
Interval 13512.2 to 18507.5
|
1150 Titer
Interval 957.4 to 1380.3
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
B 50%: Before vaccination
|
1756 Titer
Interval 1513.0 to 2038.3
|
1756 Titer
Interval 1475.2 to 2090.8
|
1647 Titer
Interval 1387.5 to 1955.6
|
1792 Titer
Interval 1510.8 to 2125.2
|
1652 Titer
Interval 1419.8 to 1923.2
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
B 50%: 2 Weeks after vaccination
|
39152 Titer
Interval 31938.0 to 47996.6
|
36382 Titer
Interval 28841.0 to 45893.9
|
43030 Titer
Interval 35419.6 to 52275.2
|
55967 Titer
Interval 46848.7 to 66861.1
|
1615 Titer
Interval 1354.4 to 1926.1
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
B 50%: 1 Month after vaccination
|
34397 Titer
Interval 28139.5 to 42046.9
|
37931 Titer
Interval 31958.7 to 45019.8
|
30339 Titer
Interval 23978.7 to 38387.3
|
39055 Titer
Interval 32898.8 to 46363.2
|
1686 Titer
Interval 1415.4 to 2007.3
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
B 50%: At delivery
|
16157 Titer
Interval 12864.8 to 20291.4
|
19952 Titer
Interval 16221.3 to 24540.1
|
16011 Titer
Interval 12916.4 to 19847.7
|
19130 Titer
Interval 15276.7 to 23955.2
|
1184 Titer
Interval 977.1 to 1435.7
|
SECONDARY outcome
Timeframe: 2 weeks and 1 month after vaccination, at deliveryPopulation: Maternal evaluable immunogenicity population: eligible maternal participants who received randomized vaccine, had blood collection within protocol-specified time points, had at least 1 valid and determinate assay result after vaccination and had no other major protocol deviations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMFRs for RSV A and RSV B neutralizing antibody titers from before vaccination to each available time point after vaccination were calculated by exponentiating the mean logarithm of the fold rises. Corresponding 95% CI was based on the Student t distribution. Data for this outcome measure was planned to be analyzed for maternal participants only.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=106 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=108 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=103 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=103 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=111 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
B 50%: 2 Weeks after vaccination
|
21.8 Fold rise
Interval 17.24 to 27.47
|
21.0 Fold rise
Interval 16.69 to 26.35
|
26.4 Fold rise
Interval 21.36 to 32.51
|
30.4 Fold rise
Interval 24.35 to 37.83
|
1.0 Fold rise
Interval 0.84 to 1.16
|
|
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
B 50%: 1 Month after vaccination
|
19.2 Fold rise
Interval 15.43 to 23.84
|
22.0 Fold rise
Interval 18.3 to 26.41
|
17.7 Fold rise
Interval 13.94 to 22.51
|
20.9 Fold rise
Interval 17.42 to 25.12
|
1.0 Fold rise
Interval 0.9 to 1.17
|
|
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
A 50%: 2 Weeks after vaccination
|
19.8 Fold rise
Interval 16.35 to 24.04
|
20.4 Fold rise
Interval 16.12 to 25.77
|
23.3 Fold rise
Interval 19.27 to 28.1
|
25.3 Fold rise
Interval 20.97 to 30.52
|
1.1 Fold rise
Interval 0.95 to 1.28
|
|
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
A 50%: 1 Month after vaccination
|
14.9 Fold rise
Interval 11.89 to 18.65
|
19.6 Fold rise
Interval 16.21 to 23.61
|
15.9 Fold rise
Interval 12.85 to 19.8
|
17.8 Fold rise
Interval 14.99 to 21.04
|
1.0 Fold rise
Interval 0.94 to 1.18
|
|
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
A 50%: At delivery
|
8.3 Fold rise
Interval 6.85 to 10.05
|
10.9 Fold rise
Interval 9.33 to 12.78
|
8.6 Fold rise
Interval 6.81 to 10.74
|
10.6 Fold rise
Interval 8.91 to 12.56
|
0.8 Fold rise
Interval 0.67 to 0.95
|
|
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
B 50%: At delivery
|
9.2 Fold rise
Interval 7.19 to 11.74
|
11.2 Fold rise
Interval 9.2 to 13.74
|
9.5 Fold rise
Interval 7.8 to 11.48
|
10.7 Fold rise
Interval 8.49 to 13.49
|
0.7 Fold rise
Interval 0.61 to 0.87
|
SECONDARY outcome
Timeframe: At birth and at 1, 2, 4, 6 months after birthPopulation: Infant evaluable immunogenicity population: eligible infant participants born to maternal participants who received randomized vaccine and had no protocol deviation before delivery, had blood collection within protocol-specified time point at birth, had at least 1 valid, determinate assay result at birth and had no other major protocol deviations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student t distribution. GMRs of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
Outcome measures
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=100 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=109 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=103 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=104 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=106 Participants
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
A 50%: At birth
|
22904 Titer
Interval 18636.8 to 28147.5
|
23281 Titer
Interval 19155.8 to 28294.3
|
20530 Titer
Interval 17271.7 to 24403.0
|
24290 Titer
Interval 19858.5 to 29710.2
|
2150 Titer
Interval 1776.7 to 2602.6
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
A 50%: 1 Month after birth
|
13532 Titer
Interval 8775.4 to 20865.4
|
14667 Titer
Interval 10428.4 to 20627.6
|
12685 Titer
Interval 9161.6 to 17563.9
|
15383 Titer
Interval 12253.4 to 19311.4
|
1514 Titer
Interval 1200.9 to 1908.0
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
A 50%: 2 Months after birth
|
11127 Titer
Interval 8424.3 to 14695.8
|
7455 Titer
Interval 5517.1 to 10073.8
|
6943 Titer
Interval 4890.5 to 9858.0
|
10552 Titer
Interval 8019.3 to 13884.7
|
702 Titer
Interval 529.5 to 930.8
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
A 50%: 4 Months after birth
|
2673 Titer
Interval 1904.5 to 3753.0
|
3919 Titer
Interval 2905.9 to 5285.8
|
2148 Titer
Interval 1681.5 to 2743.3
|
2936 Titer
Interval 2217.6 to 3887.3
|
478 Titer
Interval 336.3 to 680.2
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
A 50%: 6 Months after birth
|
1529 Titer
Interval 1164.8 to 2008.3
|
1124 Titer
Interval 790.0 to 1600.4
|
930 Titer
Interval 643.0 to 1344.2
|
1048 Titer
Interval 747.6 to 1468.5
|
233 Titer
Interval 176.2 to 307.0
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
B 50%: At birth
|
30195 Titer
Interval 24308.9 to 37506.3
|
28437 Titer
Interval 22968.2 to 35207.9
|
25112 Titer
Interval 20172.4 to 31262.1
|
32967 Titer
Interval 27494.5 to 39529.5
|
2029 Titer
Interval 1669.5 to 2466.2
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
B 50%: 1 Month after birth
|
17418 Titer
Interval 11133.3 to 27251.5
|
18708 Titer
Interval 12994.4 to 26934.9
|
17911 Titer
Interval 12397.2 to 25876.7
|
20353 Titer
Interval 15477.7 to 26762.8
|
1586 Titer
Interval 1181.0 to 2129.1
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
B 50%: 2 Months after birth
|
13411 Titer
Interval 10016.5 to 17955.2
|
8341 Titer
Interval 5847.7 to 11898.6
|
7251 Titer
Interval 5387.9 to 9757.8
|
12359 Titer
Interval 9060.4 to 16857.4
|
700 Titer
Interval 542.3 to 903.6
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
B 50%: 4 Months after birth
|
3168 Titer
Interval 2261.8 to 4436.5
|
4075 Titer
Interval 2952.0 to 5624.6
|
2621 Titer
Interval 2029.1 to 3385.5
|
4135 Titer
Interval 3093.4 to 5526.2
|
458 Titer
Interval 313.6 to 668.3
|
|
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
B 50%: 6 Months after birth
|
1609 Titer
Interval 1094.5 to 2364.3
|
1195 Titer
Interval 805.8 to 1772.0
|
956 Titer
Interval 656.8 to 1392.7
|
1381 Titer
Interval 966.6 to 1972.0
|
221 Titer
Interval 162.9 to 300.9
|
Adverse Events
Maternal Participants: RSVpreF 120 mcg
Serious events: 7 serious events
Other events: 87 other events
Deaths: 0 deaths
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
Serious events: 15 serious events
Other events: 108 other events
Deaths: 0 deaths
Maternal Participants: RSVpreF 240 mcg
Serious events: 15 serious events
Other events: 96 other events
Deaths: 0 deaths
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
Serious events: 19 serious events
Other events: 103 other events
Deaths: 0 deaths
Maternal Participants: Placebo
Serious events: 14 serious events
Other events: 89 other events
Deaths: 0 deaths
Infant Participants: RSVpreF 120 mcg
Serious events: 41 serious events
Other events: 66 other events
Deaths: 0 deaths
Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide
Serious events: 39 serious events
Other events: 59 other events
Deaths: 0 deaths
Infant Participants: RSVpreF 240 mcg
Serious events: 35 serious events
Other events: 67 other events
Deaths: 0 deaths
Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide
Serious events: 44 serious events
Other events: 66 other events
Deaths: 0 deaths
Infant Participants: Placebo
Serious events: 38 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=115 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=116 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=114 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=117 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
Infant Participants: RSVpreF 120 mcg
n=114 participants at risk
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 participants at risk
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg
n=113 participants at risk
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=112 participants at risk
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: Placebo
n=116 participants at risk
Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Cardiac disorders
Baseline foetal heart rate variability disorder
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Cardiac disorders
Foetal heart rate deceleration abnormality
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Cardiac disorders
Nonreassuring foetal heart rate pattern
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Cardiac disorders
Tachycardia foetal
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Pyrexia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Amniotic cavity infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Anorectal cellulitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Appendicitis
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Endometritis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Endometritis decidual
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Gastroenteritis
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Mastitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Oophoritis
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Salpingitis
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Uterine rupture
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Body temperature increased
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Foetal heart rate decreased
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Foetal heart rate indeterminate
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Influenza virus test positive
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Migraine
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Arrested labour
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged rupture of membranes
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord abnormality
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine tachysystole
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Alpers disease
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.4%
5/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Aplasia cutis congenita
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Birth mark
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Chordee
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Chromosomal deletion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Cleft lip
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Cleft palate
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Congenital coronary artery malformation
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Congenital naevus
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
7.0%
8/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.8%
8/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.3%
6/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
8.0%
9/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Congenital skin dimples
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Congenital tracheomalacia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Congenital umbilical hernia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.3%
6/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Double ureter
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Gastrointestinal disorder congenital
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Haemoglobin D trait
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Labial tie
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Naevus flammeus
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.6%
4/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Penile torsion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Penoscrotal fusion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Spina bifida cystica
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Supernumerary nipple
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Vascular malformation
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Congenital, familial and genetic disorders
XYY syndrome
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Gingival cyst
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Tongue cyst
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.3%
6/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.4%
5/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.2%
7/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.2%
6/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Hypothermia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
COVID-19
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Sepsis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Acoustic stimulation tests abnormal
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Cardiac murmur
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Cardiac murmur functional
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Right ventricular systolic pressure
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Clonic convulsion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Encephalopathy neonatal
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Peripheral nerve palsy
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Reproductive system and breast disorders
Testicular retraction
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Skin and subcutaneous tissue disorders
Cafe au lait spots
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Vascular disorders
Subgaleal haemorrhage
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Meconium aspiration syndrome
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal aspiration
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal pneumothorax
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory depression
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Transient tachypnoea of the newborn
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
Other adverse events
| Measure |
Maternal Participants: RSVpreF 120 mcg
n=115 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg
n=116 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=114 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.
|
Maternal Participants: Placebo
n=117 participants at risk
Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.
|
Infant Participants: RSVpreF 120 mcg
n=114 participants at risk
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide
n=117 participants at risk
Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg
n=113 participants at risk
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide
n=112 participants at risk
Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
Infant Participants: Placebo
n=116 participants at risk
Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
1.7%
2/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
14.8%
17/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
12.0%
14/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
20.7%
24/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
10.5%
12/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
9.4%
11/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Headache
|
1.7%
2/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
27.0%
31/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
43.6%
51/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
34.5%
40/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
36.0%
41/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
12.0%
14/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
2/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Cardiac disorders
Nonreassuring foetal heart rate pattern
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHOEA)
|
13.0%
15/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
11.1%
13/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
11.2%
13/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
11.4%
13/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
13.7%
16/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.3%
6/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.2%
7/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
7.8%
9/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
2/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Nausea
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Nausea (NAUSEA)
|
32.2%
37/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
26.5%
31/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
25.0%
29/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
19.3%
22/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
22.2%
26/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
16.5%
19/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
12.8%
15/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.9%
8/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.4%
5/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
7.7%
9/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Fatigue (FATIGUE)
|
47.8%
55/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
47.0%
55/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
45.7%
53/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
50.9%
58/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
47.0%
55/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Injection site erythema (REDNESS)
|
4.3%
5/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.0%
7/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Injection site pain (PAIN AT INJECTION SITE)
|
28.7%
33/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
69.2%
81/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
34.5%
40/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
60.5%
69/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
12.8%
15/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Injection site swelling (SWELLING)
|
3.5%
4/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.1%
6/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.2%
6/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.4%
5/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Oedema peripheral
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Pyrexia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.4%
5/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.4%
5/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.6%
4/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
General disorders
Pyrexia (FEVER)
|
3.5%
4/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.1%
6/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Bacterial disease carrier
|
1.7%
2/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Gastroenteritis
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Mastitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.2%
7/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
3/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
21.1%
24/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
17.9%
21/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
16.8%
19/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
13.4%
15/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
13.8%
16/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
3/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Bacterial test positive
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Blood pressure increased
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
SARS-CoV-2 test positive
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Streptococcus test positive
|
4.3%
5/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.4%
5/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Headache (HEADACHE)
|
28.7%
33/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
36.8%
43/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
37.1%
43/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
28.9%
33/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
25.6%
30/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Migraine
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
5.2%
6/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.0%
7/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Shoulder dystocia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Psychiatric disorders
Anxiety
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Psychiatric disorders
Perinatal depression
|
4.3%
5/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.1%
7/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.0%
7/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.4%
6/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
7.0%
8/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
8.0%
9/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
7.1%
8/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.9%
8/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.87%
1/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
2/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.2%
6/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Vascular disorders
Hypertension
|
2.6%
3/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.4%
5/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.1%
6/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
8.9%
10/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
10.5%
12/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.0%
7/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
7.1%
8/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.4%
6/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Investigations
Cardiac murmur
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
6.2%
7/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
8.8%
10/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
8.5%
10/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
7.1%
8/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
8.9%
10/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Transient tachypnoea of the newborn
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.3%
6/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Candida infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.6%
4/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Ear infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.5%
5/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Otitis media
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.4%
4/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.4%
6/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
7.8%
9/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
4.3%
5/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
5.4%
6/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.88%
1/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.89%
1/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Skin candida
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.8%
2/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.86%
1/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Viral infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.85%
1/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/115 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
0.00%
0/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
3.5%
4/114 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
1.7%
2/117 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/113 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.7%
3/112 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
2.6%
3/116 • Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER